The development of new chemistry-based products for life science markets requires the expertise of talented researchers. However, these same researchers are typically not prepared to solve the many other critical problems necessary for successful commercialization. Without the requisite expertise in scale up and commercialization, many early-stage companies find that competitors beat them to the market or resources run out before success can be achieved.
2. Scale-up is generally defined as the process of
increasing the batch size.
Scale-up of a process can also be viewed as a
procedure for applying the same process to
different output volumes.
“scale-up” simply means enlarging the output
by increasing the speed.
3. some of the more common scale-up errors
are:
• Scaling based on wrong unit operation
mechanisms.
• Incompletely characterized equipment, e.g.,
multishaft mixers/homogenizers.
• Insufficient knowledge of process.
lack of important process information.
• Utilization of different types of equipment at
different levels of scale-up.
4. Unrealistic expectations (e.g., heat dissipation)
Changes in product or process (e.g., altered
formulation, phase changes,changes in order
of addition) during scale-up.
5. The scale-up of biotechnology products
requires an understanding of the cellular and
regulatory mechanisms that govern cell
physiology and the biophysical and
biochemical characteristics of products.
The true measure of successful scale-up is
validation of the process at manufacturing
scale and ultimate approval of the product.
6. Successful scale-up requires that
manufacturing personnel be properly trained
on process requirements and Good
Manufacturing Practices to provide an
efficient and seamless transition into
commercial production within the shortest
time possible.
7. In order to scale up and transfer a process
successfully from laboratory scale to pilot
scale and multiple commercial manufacturing
scales, a thorough understanding of the
integration of scale factors, facility design,
equipment design, and process performance is
necessary.
A scale-up template spreadsheet can be a
useful tool to provide the critical integration of
multiple factors.
8. Commercialisation is the process of
introducing a new process or production
method into commerce making it available on
the market.
The commercialisation process has three key
aspects ,
The funnel. It is essential to look at many ideas
to get one or two products or businesses that
can be sustained long term.
9. Commercialisation is a stage wise process, and each
step has its own key goals and milestones.
It is vital to involve key stakeholders early, including
customers.
Commercialisation of a product can raise the following
questions
When to launch
Where to launch
Whom to target
How to launch
10. Commercialisation of biotechnology
discoveries has many challenges
One of the major hurdles to commercialisation
is achieving regulatory approval.
It includes not only approval for the drug but
also the process by which it is produced.
An integrated approach to the product and
process development is not taken to their
business plan.
11. The evaluation of the following 10 factors
identified as potentially important in
determining the future position of the United
States and other countries in the
commercialization of biotechnology:
financing and tax incentives for firms
government funding of basic and applied
research
personnel availability and training
12. health, safety, and environmental regulation
intellectual property law
university/industry relationships
antitrust law
international technology transfer, investment,
and trade
government targeting policies in
biotechnology
public perception.