Thermo Fisher Scientific is responding by increasing capacity and diversifying into new geographies and innovative therapies

12 November 2021 | Friday | Influencers

BioPharma APAC in an Interaction with Eric Nalbach, General Manager, Media, Thermo Fisher Scientific who has more than two decades of experience in the development and manufacturing of cell culture products. He is currently working to improve and expand global manufacturing capabilities—including Gibco (Advanced Granulation Technology™) AGT™ facility operations in Paisley, Scotland.
BioPharma APAC Thought Leadership Series 2021

BioPharma APAC Thought Leadership Series 2021

1) What strategic changes have you brought about within the business due to COVID-19?

Essential to Thermo Fisher Scientific’s ability to support biopharmaceutical developers and manufacturers is its media manufacturing footprint. Thermo Fisher scientific with its multiple Cell culture media manufacturing sites is well positioned to support customers during COVID-19. Our strict quality standards and practices, particularly for raw materials and manufacturing are harmonized between facilities to maintain consistent quality and provide manufacturing equivalency. Our manufacturing capabilities coupled with high performing catalog and custom media products enabled Thermo Fisher to maintain supply continuity during COVID-19.   

2) What are the major plans/launches/investments in store for 2022?

The pipeline of biologic modalities continues to grow and diversify.  Over the last decade, significant advancements have been made in the area of cell and gene therapy driving the need for standardized processes with fit-for-purpose, automated and end-to-end solutions.  Thermo Fisher Scientific is committed to providing innovative workflow solutions for these emerging modalities to address process intensification and speed-to-clinic market requirements.

For cell therapy, there is increased interest in allogeneic workflows which have great potential to offer increased scalability, using cells from healthy donors to create a cell bank system that may be used to treat multiple patients.  Gibco™ CTS™ OpTimizer™ Pro SFM cell culture media, a novel serum-free medium has been specifically formulated for the growth and expansion of human T lymphocytes for use in allogeneic cell therapy workflows. This product marks a major step forward for the wider use of allogeneic workflows for immunotherapy manufacture which, by enabling large-scale production, has the potential to dramatically increase access to these treatments.

Additionally, we are committed and focused to address cell isolation and activation with automation to improve autologous cell therapy manufacturing.  In 2022, Thermo Fisher Scientific will introduce Gibco™ CTS™ DynaCellect™ Magnetic Separation System, an automated, closed system comprised of a rocker, magnet, fluidics, and a fit-for-purpose single-use apparatus all managed by a graphical user interface (GUI) to streamline cell therapy isolation and activation in tandem with our new detachable bead technology.

Another vital therapeutic area that Thermo Fisher Scientific is working to revolutionize is gene therapy. In particular, accelerating the development of these life-changing therapies by improving the efficiency of AAV vector production media optimization through the development of HEK239 media panels. Released in March 2021, these panels offer a diverse set of formulations, which are designed to offer the greatest amount of nutritional diversity and help reduce the time spent screening and developing an ideal medium. In 2022, our focus will remain to deliver fit-for-purpose media products that will improve viral vector productivity and yield.  Lastly, will continue to support gene therapy developers with custom media optimization projects, to specifically optimize for their cell culture process for specific AAV serotypes utilizing OMICS analysis.

Of course, cell and gene therapies are dependent on plasmids. pDNA is a key raw material to produce emerging modalities such as viral vectors for gene therapies and mRNA for SARS-CoV-2 vaccines and long-term for other applications such as immuno-oncology (personalized cancer vaccines), therapeutics for rare diseases etc.  Gibco™ Bacto™ CD Supreme, the first chemically defined cell culture medium for microbial fermentation, will be addressing bottlenecks in pDNA production by providing desired high-cell-density and increased production yields.


3) Are you exploring new markets/regions as a part of your growth plan?

With the unprecedented pressure on the biopharmaceutical industry today, Thermo Fisher Scientific is responding by increasing capacity and diversifying into new geographies and innovative therapies. Asia is of particular importance for us as we are seeing impressive growth of mAbs, vaccines, and coming from this region. With more than 30 manufacturing, assembly, and distribution locations globally that meet or exceed the industry quality standards and ongoing capital improvement projects, we are confident we can meet the growing needs of this important region.


4) What new/unique trends do you foresee within the life sciences space in the coming years?

Recently, Thermo Fisher Scientific made considerable developments in its use of multi-omics analysis, in particular proteomics and metabolomics, to streamline media development, optimization, and troubleshooting. By using state-of-the-art analytical technology and software, this approach can convert large amounts of data into actionable insights, far beyond what can be achieved with traditional spent media analysis. As an example, a multi-omics and bioinformatics modeling approach was used to develop Gibco Efficient-Pro Medium and Feeds. Proteins and metabolites were identified using mass spectrometry. The data was then analyzed to identify what pathways would have the largest effect on titer.

5) How is the Pharma & Vaccine market evolving post-pandemic? 

We are observing broad and significant R&D and manufacturing investment increases across the biologics market from both manufacturers and vendors to support growing demand, supply continuity challenges and shifting treatment modalities due to clinical success and commercialization of mRNA vaccines. In line with these investments we are observing a renewed focus on supply chains essential to supporting complex manufacturing processes.  These efforts include dual source qualification and site redundancies, submission of early, accurate forecast models and orders to ensure products are available and ready for critical biopharmaceutical manufacturing.  Thermo Fisher Scientific has made similar investment to support these efforts in our global bioprocessing network including in new facilities and site expansions to exceed industry demand for Gibco cell culture media and single use products.

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