FROM INITIAL PROCESS DEVELOPMENT TO FINAL IMPLEMENTATION
There is an increasing need for biopharmaceutical manufacturers
to demonstrate viral safety and validate viral clearance capability of the
manufacturing process before market approval. Viral safety is a critical
element in both upstream and downstream processes. Viral clearance
steps are cost-intensive as well as a challenging aspect of bioprocess
development.
Ahead of the upcoming course on Viral Safety being organized by
Sartorius Stedim India Pvt. Ltd. in Bangalore, Sartorius India Training
& Technical Marketing Manager Smita Kumar spoke with the Sartorius
Stedim Biotech faculty, Dr. Yu Chen (Field Marketing Manager, Purification
Technologies, Asia Pacific) and Amit Khanna (Field Marketing Manager,
Filtration & Purification Technologies, India). They discussed the current
trends, regulatory requirements and industry approaches for viral safety
of biologic products.
Significance of Viral Safety
Smita: Why is viral safety more process oriented and not just a
single step within the manufacturing process?
Dr. Chen: Virus safety is one of the most stringent requirements
from regulatory bodies for biological therapeutics. In addition to
starting material and final product testing, the production process must
demonstrate robust virus clearance capabilities to protect patients
against the ‘worst case scenario’. These processes include a series of virus
removal and inactivation processes with orthogonal technologies in the
downstream processing. All these processes must be validated individually
for different viruses respectively, and finally calculated as a whole to meet
the regulatory requirements. That’s why it is seen as a whole process
rather than one or two steps.
Amit: GMP tells you to control your process from every aspect and
not depend on just one removal step. It starts with risk mitigation for the
process and concludes with having multiple technologies to inactivate
and remove viruses along with the process validation of the same.Process Bottlenecks and Costs
Smita: What are the critical considerations to overcome process
challenges including containing costs involved in virus clearance steps,
both in upstream and downstream processes?
Dr. Chen: Virus clearance processes, especially virus filtration, are
one of the most costly processes in unit operations. It is not uncommon
that many people don’t see it as a ‘real process development’ but just
simple validations with existing process conditions. However, there
is actually a lot more room we can play to improve these processes
including virus inactivation, Chroma removal and virus filtrations. For
example, optimization of sample/buffer conditions, selection of Chroma
media and virus filter membranes, optimization of pre-filters... All these
optimizations play an important role in process throughput, LRV, process
time and process robustness. A fully optimized process can show you
several times higher throughput and save you a lot of material cost as
well as process time. A properly developed virus clearance process also
ensures process robustness and effective virus removal, which secure your
clinical trials from early stage till commercial manufacturing.
Amit: Virus filtration is one of the most expensive unit operations in
downstream processing. Process optimization of this step would include
pre filtering the feed stream to get rid of contaminants and thus lower the
virus filter size. Choosing a virus filter which can give high LRV even with
flux decay will further enable to downsize a virus filter.To hear more on such topics from industry leaders and biopharma experts from across the globe, be part of the training course:
‘Viral Clearance Strategies in Biomanufacturing’ on September 24th & 25th, 2018 at Sartorius India Campus, Bangalore.
Call +91 80 681 541 35 or write to [email protected] for further information.ADVERTORIALADDRESSING CHALLENGES &
LATEST TRENDS IN VIRAL SAFETY