Expert Insights On Fill/Finish
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A Practical Guide To Navigate The EU's Revised GMP Annex 1
9/9/2022
The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.
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The Environmental Impact Of Biopharma Continuous Manufacturing: Part II
8/22/2022
Part 1 of this two-part series began to compare the environmental impact of biopharma continuous manufacturing with batch manufacturing. In this article, the author considers process efficiency, single-use technology, and facilities requirements.
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Manufacturing Biotherapeutics Based On Synthetic Biology: Lessons Learned
7/8/2022
In 2014, Synlogic's co-founders formed the first company that would apply the principles of synthetic biology to the creation and development of biotherapeutics. This article shares their journey in overcoming challenges in producing synthetic biotics, considering new approaches in manufacturing, and the benefits of a hybrid production model.
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2022 Outsourcing Trends In Biopharmaceutical Manufacturing
6/15/2022
The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.
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Biopharma In China: The Emerging Global Force Of Domestic Suppliers
5/23/2022
Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.
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Key Considerations For Decarbonizing Your Biotech Facility
5/4/2022
Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.
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mRNA Vaccines: Key Considerations For Development & Manufacturing
4/4/2022
As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
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The 13-Step Guide For Conducting Cell & Gene Therapy EHS Risk Assessments
3/14/2022
One of the hurdles for cell and gene therapy manufacturers is the lack of health and safety guidelines. This article summarizes the main steps in a suggested EHS risk assessment process. It can form the basis for discussions between a contract manufacturer and client or between production and development departments. What could go wrong?
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Single-Use Technologies: A Game Changer For Expanding mAb Production
3/4/2022
A biotech company that this author worked with had an expanding pipeline and needed to increase its manufacturing capacity, so single-use technologies were implemented from media prep through buff prep, to seed train and through the downstream process. The company saw a dramatic reduction of production costs.
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2021's Bioprocessing Year In Review And 7 Key Takeaways
1/11/2022
The biopharma industry has responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have created the need for new strategies. Explore more in BioPlan Associates’ 2021 18th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.