The document discusses the scale-up process in biotechnology, emphasizing the need for careful planning and understanding of various factors such as process characterization, equipment, and regulatory compliance. It highlights common errors made during scale-up and stresses the importance of training for manufacturing personnel. Furthermore, it outlines the commercialization process, noting challenges like regulatory approval and the necessity of integrating product and process development while engaging stakeholders.

1. PREPARED BY,
VISHNU GM
2014-09-111

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.