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Watch the presentation of this webinar here: https://bit.ly/3b7vD60 Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode. Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety. In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode. In this webinar, you will learn: • The context of closed processing • Differences between closed and functionally closed processing • The drivers for adoption • Its practical implementation to a TFF step
Single-Use Tangential Flow Filtration for Closed Processing
Single-Use Tangential Flow Filtration for Closed Processing
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What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use. In this webinar, you will learn: • Closed Processing and Single Use Technology implementation • Points to consider using Single Use Technology • Sterile Filtration The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
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Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1 In this webinar, you will learn: - About the GMP Annex 1 draft regulatory overview - How to incorporate the integrity testing & PUPSIT in the filtration systems validation - How to design a bacterial retention test in terms of organism selection and single vs multiple use validation Detailed description: In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies. Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter Validation
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter Validation
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Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies. As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable. Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
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Final sterile filtration operations are the focus of extensive regulatory guidance to assure the safety of medicinal products for administration to patients. All sterilizing-grade filters must be tested for integrity after use, and current draft EMA EU Annex 1 requires pre-use, post-sterilization integrity tests (PUPSIT). This poster explores the use of final fill filters to achieve the following: • Simplify PUPSIT by reducing risk of introducing microbial contaminants to the flow path • Maximize product recovery • Create a safer and more efficient final filtration process To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
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Watch the presentation of this webinar here: https://bit.ly/3b7vD60 Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode. Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety. In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode. In this webinar, you will learn: • The context of closed processing • Differences between closed and functionally closed processing • The drivers for adoption • Its practical implementation to a TFF step
Single-Use Tangential Flow Filtration for Closed Processing
Single-Use Tangential Flow Filtration for Closed Processing
Merck Life Sciences
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use. In this webinar, you will learn: • Closed Processing and Single Use Technology implementation • Points to consider using Single Use Technology • Sterile Filtration The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...
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Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1 In this webinar, you will learn: - About the GMP Annex 1 draft regulatory overview - How to incorporate the integrity testing & PUPSIT in the filtration systems validation - How to design a bacterial retention test in terms of organism selection and single vs multiple use validation Detailed description: In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies. Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter Validation
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter Validation
MilliporeSigma
Sterile filtration and filter validation remain a critical segment during the development of these segments of products. Let's find the same by understanding a checklist and visualize certain case studies. As the sterile injectable market continues to see rapid growth (~10% to 15% per annum) – outpacing the growth of oral products – it is natural to see the diversity of parenteral product formulations increasing in parallel. The definition of complexity in parenteral formulation development is broad. It varies based on the stage of development and the specific nature of the challenge. A notionally simple, stable reproducible laboratory formulation may carry a level of complexity in aseptic control if routine means of sterilization are unavailable. Sterile filtration process intensification can bring significant benefits to manufacturers in terms of manufacturing flexibility, reduction of risks, better turn around time, thus achieving significantly higher productivity. We will identify these scenarios with case studies to reduce complications in manufacturing and process development.
Sterile filtration of complex injectables by Partha Banerjee
Sterile filtration of complex injectables by Partha Banerjee
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Final sterile filtration operations are the focus of extensive regulatory guidance to assure the safety of medicinal products for administration to patients. All sterilizing-grade filters must be tested for integrity after use, and current draft EMA EU Annex 1 requires pre-use, post-sterilization integrity tests (PUPSIT). This poster explores the use of final fill filters to achieve the following: • Simplify PUPSIT by reducing risk of introducing microbial contaminants to the flow path • Maximize product recovery • Create a safer and more efficient final filtration process To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/mlab
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ADC Production - A Journey made safer and faster
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Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
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We will introduce an excipient platform that makes it possible to combine excipients in ways that can reduce protein viscosity to a greater extent. *About challenges arising from high concentrated protein formulations *The Viscosity reduction Platform: A portfolio of excipients to manage protein viscosity *Impact of viscosity reducing excipient use on protein stability *Impact of protein viscosity on syringeability
The Viscosity Reduction Platform: Enabling subcutaneous (subQ) delivery
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Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership. In this webinar, you will learn: • Selection of right excipients for high risk formulation is very critical step • Low Endotoxin and low bioburden limits are important aspect while selecting raw materials • Strong regulatory support is crucial for high risk formulation Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Excipients selection for high risk formulations Smita Rajput
Excipients selection for high risk formulations Smita Rajput
Merck Life Sciences
Final sterile filtration operations are the focus of extensive regulatory guidance to assure the safety of medicinal products for administration to patients. All sterilizing-grade filters must be tested for integrity after use, and current draft EMA EU Annex 1 requires pre-use, post-sterilization integrity tests (PUPSIT). This poster explores the use of final fill filters to achieve the following: • Simplify PUPSIT by reducing risk of introducing microbial contaminants to the flow path • Maximize product recovery • Create a safer and more efficient final filtration process To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
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Watch this webinar here: https://bit.ly/32cbiHt This webinar will introduce PVA as an optimized excipient for sustained release formulations. Combining direct-compression compatibility with a robust and reliable matrix formation, PVA has the potential to enhance sustained release formulations. By modifying the drug release characteristics, significant therapeutic benefits can be achieved, such as improved efficacy of the therapeutic agent, reduced adverse effects, optimization of the dosing scheme and overall improvement in patient compliance. There are numerous approaches for modified release, each with its own benefits and drawbacks. This webinar will present PVA, a fully-synthetic polymer, for optimized sustained release matrix formulations. Combining robust and reliable gel-forming behavior with optimized tableting properties, PVA provides solutions for the most challenging sustained release formulations. In this webinar, you will learn: • How the gel-formation properties of PVA introduce sustained release • Why compatibility with direct compression leads to simplified formulations • That PVA can provide flexibility in sustained release formulation development
PVA for sustained release: theory and practice
PVA for sustained release: theory and practice
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In this webinar, you will learn: - how to measure filter performance and capacity, - how to optimize filter virus removal capability, - and avoid potential pit-falls Detailed description: This webinar will cover all aspects of parvovirus filtration best practices: process development/ optimization, pilot scale-up, and validation and explain the important connections between these activities. The rationale for the recommended best practices will be explained by discussing the underlying mechanisms that control filter performance.
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Access the interactive recording here: https://bit.ly/2mvFxs7 Abstract: The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997. There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use. This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
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Potential Impact of Draft Annex 1 on Sterilizing Filtration
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The complex injectable market is gaining traction in the injectable therapies, however manufacturing of it is critical. In this webinar, lets brainstorm on the downstream criticalities of these molecules and how to handle the same.
Addressing Downstream Challenges with Complex Injectables
Addressing Downstream Challenges with Complex Injectables
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Watch the presentation of this webinar here: https://bit.ly/3bJypPv Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time. In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy. The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality. In this webinar, you will learn: • How to create your coating formulation by utilizing a broad excipient toolbox • Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances • Creating the perfect surface finishing • How to utilize novel analytical technologies to boost your formulation development
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...
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Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship. Explore our webinar library: www.merckmillipore.com/webinars
Using Single-use Technology to Overcome the Challenges of ADC Processing
Using Single-use Technology to Overcome the Challenges of ADC Processing
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Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs). In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations. This webinar includes: - The current status and further potential of HME in pharmaceutical industry - Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options - Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions In this webinar, you will learn: - which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) - why PVA is more than just a polymer - how to create your final dosage form and speed up your formulation development
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Dr. Prashant L. Pingale GES's Sir Dr. M. S. Gosavi College of Pharmacy, Nashik
Access the interactive recording: https://bit.ly/2PSxDUj Abstract: Hot melt extrusion is considered to be one of the most effective technology for the creation of solid dispersion. Its rapid advancement in the development of new pharmaceutical products highlights its importance. In this webinar you will learn about the potential of hot melt extrusion technology to overcome challenges in solubility and bioavailability of drug substances by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as an overview of actual formulation trends. You will gain insights in novel screening tools for hot melt extrusion which can represent a decisive strategic advantage at early development stages. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. Another aspect involves the versatile down-stream options to create your final dosage form as well as innovative applications. In this webinar, you will learn: * about amorphous solid dispersions and their preparation by hot melt extrusion * how to identify the right polymer at early development stages * how to improve the performance of your formulation by using polyvinyl alcohol
Hot melt extrusion with PVA: A new opportunity for challenging APIs
Hot melt extrusion with PVA: A new opportunity for challenging APIs
Merck Life Sciences
Layout of Tablet Manufacturing Section
Layout of Tablet Manufacturing Section
Nitin Kadam
NIRMAN CONSTRUCTIONS one of the leading construction chemical applicator from Gujarat. We undertake turn key projects of Epoxy Flooring, Water proofing, Structural Repairing ang rehabilitation jobs, Groove cutting and filling, core cutting, tremix flooring and all type Civil jobs etc.
Company profile nirman conlatest -2
Company profile nirman conlatest -2
nirmanconstructions
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In this webinar, you will learn: How Single-Use helps to simplify ADC manufacturing Safety and Integrity of the complete process Flexibility and adaptability to changing needs How to speed up the synthesis of high-potent payloads and improve the bioavailability of the ADC Detailed description: The development of an ADC is a long journey that can be speeded-up with the adoption of proper manufacturing tools and new linker-payload solutions. Single-Use equipment applied to the GMP manufacturing of ADC means operator safety, decreased risk of contamination, scalability, reproducibility, flexibility, small footprint, lower cost, and saved time through efficiency (easy setup and cleanup, no need for cleaning validation). The adoption of payload intermediates such as DolCoreTM and MayCoreTM can speed your development project up, while innovative linkers like ChetoSensarTM increase its chances of success. This webinar explains how these technologies improve the ADC production process end-to-end, ultimately enhancing patient safety.
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Excipients selection for high risk formulations Smita Rajput
Merck Life Sciences
Final sterile filtration operations are the focus of extensive regulatory guidance to assure the safety of medicinal products for administration to patients. All sterilizing-grade filters must be tested for integrity after use, and current draft EMA EU Annex 1 requires pre-use, post-sterilization integrity tests (PUPSIT). This poster explores the use of final fill filters to achieve the following: • Simplify PUPSIT by reducing risk of introducing microbial contaminants to the flow path • Maximize product recovery • Create a safer and more efficient final filtration process To learn more about this topic or collaborate with our technical experts, schedule an in-person or remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/mlab
Reducing Contamination Risk and Improving Product Recovery During Final Steri...
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Watch this webinar here: https://bit.ly/32cbiHt This webinar will introduce PVA as an optimized excipient for sustained release formulations. Combining direct-compression compatibility with a robust and reliable matrix formation, PVA has the potential to enhance sustained release formulations. By modifying the drug release characteristics, significant therapeutic benefits can be achieved, such as improved efficacy of the therapeutic agent, reduced adverse effects, optimization of the dosing scheme and overall improvement in patient compliance. There are numerous approaches for modified release, each with its own benefits and drawbacks. This webinar will present PVA, a fully-synthetic polymer, for optimized sustained release matrix formulations. Combining robust and reliable gel-forming behavior with optimized tableting properties, PVA provides solutions for the most challenging sustained release formulations. In this webinar, you will learn: • How the gel-formation properties of PVA introduce sustained release • Why compatibility with direct compression leads to simplified formulations • That PVA can provide flexibility in sustained release formulation development
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Access the interactive recording here: https://bit.ly/2mvFxs7 Abstract: The support for EMA GMPs related to sterile medicinal products is Annex 1. EMA, PICS and WHO have collaborated on the largest and most comprehensive revision of Annex 1 since it was first written in 1997. There are a number of proposed changes to the sections in Annex 1 dealing with filtration, integrity testing and single-use. This presentation will compare the current version with the proposed changes and highlight areas of specific interest to companies who either manufacture in or export to EMA countries, PICS member countries, and WHO compliant countries.
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Addressing Downstream Challenges with Complex Injectables
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Using Single-use Technology to Overcome the Challenges of ADC Processing
Using Single-use Technology to Overcome the Challenges of ADC Processing
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Hot melt extrusion has successfully emerged as an innovative manufacturing technology in pharmaceutical industry for the creation of amorphous solid dispersions (ASDs). In this webinar you will learn about the potential of hot melt extrusion to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as actual formulation trends. You will get insights in potential down-stream options to create your final dosage form and you will gain ideas on how to speed up your formulation development. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. PVA is more than a polymer. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. This highlights the versatility of PVA as an advanced polymer for HME applications and we will guide you through our latest research activities so that you can leverage our knowledge to improve your formulations. This webinar includes: - The current status and further potential of HME in pharmaceutical industry - Advantages of PVA in the field of ASDs: Solubility improvement, impact on supersaturation potential, stability data generated on sample formulations & downstream options - Deep dive into latest research activities: Permeation studies with Caco-2 cell membranes, pH shift studies to investigate supersaturation potential, ongoing research activities to get to know a more detailed understanding of matrix systems and their intermolecular interactions In this webinar, you will learn: - which potential hot melt extrusion has, to overcome challenges in API solubility and bioavailability by using polyvinyl alcohol (PVA) - why PVA is more than just a polymer - how to create your final dosage form and speed up your formulation development
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Merck Life Sciences
Pilot plant scale up for Small Volume Parenterals
Pilot plant scale up for Small Volume Parenterals
Pilot plant scale up for Small Volume Parenterals
Dr. Prashant L. Pingale GES's Sir Dr. M. S. Gosavi College of Pharmacy, Nashik
Access the interactive recording: https://bit.ly/2PSxDUj Abstract: Hot melt extrusion is considered to be one of the most effective technology for the creation of solid dispersion. Its rapid advancement in the development of new pharmaceutical products highlights its importance. In this webinar you will learn about the potential of hot melt extrusion technology to overcome challenges in solubility and bioavailability of drug substances by using polyvinyl alcohol (PVA) as a matrix polymer. We will provide an overview about different types of solid dispersions and their evolution in the pharmaceutical field. A brief introduction in hot melt extrusion processing will be given as well as an overview of actual formulation trends. You will gain insights in novel screening tools for hot melt extrusion which can represent a decisive strategic advantage at early development stages. A detailed background of PVA will be provided including its physical properties as well as its regulatory status. Due to its amphiphilic structure it has the potential to improve the supersaturation of low soluble APIs and to prevent precipitation after release. Another aspect involves the versatile down-stream options to create your final dosage form as well as innovative applications. In this webinar, you will learn: * about amorphous solid dispersions and their preparation by hot melt extrusion * how to identify the right polymer at early development stages * how to improve the performance of your formulation by using polyvinyl alcohol
Hot melt extrusion with PVA: A new opportunity for challenging APIs
Hot melt extrusion with PVA: A new opportunity for challenging APIs
Merck Life Sciences
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Pilot plant scale up for Small Volume Parenterals
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Hot melt extrusion with PVA: A new opportunity for challenging APIs
Hot melt extrusion with PVA: A new opportunity for challenging APIs
Destaque
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NIRMAN CONSTRUCTIONS one of the leading construction chemical applicator from Gujarat. We undertake turn key projects of Epoxy Flooring, Water proofing, Structural Repairing ang rehabilitation jobs, Groove cutting and filling, core cutting, tremix flooring and all type Civil jobs etc.
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StephenWu
A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
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Pilot plant scale up techniques for solid dosage forms
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ElahehEntezarmahdi
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Vijay Pisipaty
Presentation highlighting Alkermes high potency capabilities in solid oral dosage manufacture. Included in the presentation is a case study on our success tech-transferring a highly potent compound for a large pharma company.
Alkermes high potency capabilities
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Alkermes
Pilot plant scale up for tablets
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Robin Gulati
Pilot plant design for tablets and capsules
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Malla Reddy College of Pharmacy
DR Anthony Crasto scaleup techniques & pilot plant, Glenmark scientist helping millions with websites, million hits on google amcrasto@gmail.com
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Anthony Melvin Crasto Ph.D
In this guide (screenshots + descriptions), MRP Steps with exemplary data is covered in SAP. Visit http://sapdocs.info/sap/production-planning/sap-pp-mrp-user-training-document-pdf/ for free download
SAP PP MRP Guide for Beginners
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sapdocs. info
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Pharmaceutical process scale up
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JayantPatil
INTRODUCTION TYPES OF PROCESS VALIDATION PRODUCT VALIDATION PHASES OF VALIDATION VALIDATION OF TABLETS VALIDATION OF CAPSULES CONCLUSION
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Ramya priya
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Asad Mulla
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Alkermes high potency whitepaper 2014
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Effervescent Tablets
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Semelhante a Presentation Of Capabilities Elf
CoreRx, is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
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Corerx, Inc.
End-to-end services and solutions covering the entire spectrum of preclinical biopharmaceutical R&D. Supporting everything from target discovery, candidate development, preclinical screening and drug safety evaluation through IND submission. https://www.medicilon.com/about-medicilon/
High Quality Integrated Drug R&D Services
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medicilonz
PharmaSynth Biopharmaceutical Manufacturing will support you from bench to clinic to market. http://www.pharmasynth.com.au/
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marklicarde_1
CoreRx is a contract pharmaceutical development and manufacturing organization that helps get you into the clinic faster, providing a complete spectrum of cGMP solutions for pharmaceutical dosage form development. Our wide range of support services, extensive instrumentation and rigorous quality systems provide timely results communicated in a clear, efficient and consistent manner.
Core Rx Presentation
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Sitec Labs
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Aniket Manathkar
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Manuel Eduardo Fernandes
Our leading-edge manufacturing facilities located in Southern California allow PYRAMID to offer the pharmaceutical and biotech industries a wide range of services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both Clinical and Commercial products.
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Brendan O'Farrell
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market. In this webinar, you will discover more about: • How outsourcing to a CDMO partner in late-stage will increase flexibility and speed • How a risk-based approach can help you optimize your process validation strategy • How we have implemented a risk-based approach for our clients via case studies
Optimize Your Process Validation Package
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Merck Life Sciences
Kuecept Ltd was founded in 2007 by a group of experienced industrial scientists to provide customised R&D solutions and consultancy services to the pharmaceutical, biotech and health-care industries. Today, we are one of a few contract research organisations dedicated solely to providing preformulation, formulation development and enabling drug delivery services to companies in the discovery / preclinical stages. By working exclusively in this field, we have developed a wealth of knowledge and expertise of enabling drug delivery technologies and formulation know-how in drug solubility and bioavailability enhancement and with over 600 projects completed to date on over 250 NCEs, are well placed to help resolve some of the most complex drug development issues. Our experience covers a broad range of discovery, development & related activities supporting oral, parenteral and orally / nasally inhaled drug products.
Kuecept Corporate Presentation 2014
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In our final webinar of the MDC Connects Series 2021 | A Guide to Complex Medicines. This slide deck takes a closer look at overcoming the challenges of scaling up a complex medicine. Graham Worrall and Emily Port, CPI
MDC Connects Series 2021 | A Guide to Complex Medicines: Overcoming the Chall...
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Pharmaceutical pellets and product development.
Pharmaceutical Product development technology
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Umang Budhraja
Location:- GIDC Estate Ankleswar 393002, Dist. Bharuch ,Gujrat India Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4,700 people and a network of production sites - including flagship sites in Prague, Bucharest and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better supportpeople’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators and governments to provide the everyday solutions that we all depend on. About Zentiva’s Ankleshwar site Established in 1987, the Ankleshwar manufacturing site has a chemistry and biotechnology development center, and manufactures both intermediates and pharmaceutical formulations. A large producer of tablets, the Ankleshwar site manufactures more than 6 billion tablets annually. Mission &Values:- Zentiva is a leading developer and supplier of high-quality affordable prescription medicines and consumer brands. As Zentiva grows more people get the medicine they need. Our business is built on trust and responsibility with the patient at the heart of everything we do. Zentiva has established 6 shared SuperpowerZ which frame the values and behaviours we expect of our team and how we will build a healthy business that we can all be proud of. TABLET-SECTION Tablet:- A tablet is a mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid. The excipients include binders, Glidants (flow aids) and lubricants to ensure efficient tabletting, disintegrates to ensure that the tablet breaks up in the digestive tract; sweeteners or flavors to mask the taste of bad-tasting active ingredients; and pigments to make uncoated tablets visually attractive. A coating may be applied to hide the taste of the tablet's components, to make the tablet smoother and easier to swallow, and to make it more resistant to the environment, extending its shelf life. Advantage • Production aspect Large scale production at lowest cost Easiest and cheapest to package and ship High stability • User aspect (doctor, pharmacist, patient) Easy to handling. Lightest and most compact. Greatest dose precision & least content variability. Coating can mark unpleasant tastes & improve pt. acceptability. PHARMACEUTICAL PRODUCT BY ZENTIVA PHARMACEUTICAL PVT.LTD:- 1. Avil -25 mg 2. Trental-400 3. Paracetamol-500mg 4. Ramilich-( 5, 25mg) 5. Ramipril-25mg 6. Zuglimate-500mg 7. Clopidogrel-75mg 8. Metformin-100mg QUALITY CONTROL AND QUALITY ASSUARANCE Quality control is the part of GMP that deals with sampling, specification, and testing, as well as organisation, documentation, and release procedures to ensure that necessary and
INDUSTRIAL TRAINING REPORT (B-pharmacy ) Zentiva pharmaceutical industry
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What format is best for your laboratory
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Optimize Your Process Validation Package
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MDC Connects Series 2021 | A Guide to Complex Medicines: Overcoming the Chall...
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Presentation Of Capabilities Elf
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Presentation of Capabilities
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Bldg 23 Bldg
24 ‘ Border’ Facilities Penn operates from a primary site of three hectares (323,000sq.ft.) in Tredegar and a new (75,000sq.ft.) storage facility in Oakdale, South Wales. (2.5 hours west of London)
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