Expert Insights On Cell Line Development
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Assessing Quality Of mRNA Vaccines: Key Considerations
10/12/2022
To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
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Pharma Process Validation: Initial Conclusions Are Often Deceptive
9/26/2022
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.
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Qualifying Working Cell Bank Replenishment
9/6/2022
Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. The availability of well-characterized cell banks is imperative to ensure drug product supply. This article shares regulatory tips for cell bank registration and regulatory considerations when replenishing a working cell bank.
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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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The Environmental Impact Of Biopharma Continuous Manufacturing
8/8/2022
One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.
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AstraZeneca Implements A "Technology Uplift" Of Its Microbiology Labs
5/31/2022
Modern microbiology labs are busy, with a wide range of activities taking place from final product testing to auxiliary support such as quality control release checks on nutrient media. While instruments and equipment available to technicians can vary, AstraZeneca wanted a networkwide approach to modernizing its labs.
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Making An Unapprovable Drug Product Approvable: Lessons Learned
5/27/2022
This true story explores a drug product that was in the middle of Phase 3 trials, generating the keen interest of the FDA, but which suffered a commercialization setback due to manufacturing inefficiency and safety concerns. They asked us to think about how we would transform the manufacturing process into a licensable process.
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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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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?