Industry Insights
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2020 Gene Therapy Progress Wrap-Up
12/22/2020
Over the past 12 months the news has been dominated by the worldwide COVID-19 pandemic, but the work to bring gene and cell therapies to patients has not stopped. Here is a rundown of some of the most interesting developments in gene and cell therapy for the year.
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Why We Shouldn’t Be Categorizing Digital Therapeutics As Drugs
8/2/2021
Payers and health plans handle digital therapeutics inconsistently. They sometimes treat them as medications. The manufacturer would have a role in this determination. This article delves into what digital therapeutics are and are not, and why the industry should not be categorizing them as drugs.
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Continuous Improvement In Life Science Manufacturing
11/15/2022
Learn how having a 6S program tethered to a hierarchy of needs will provide safety for your team when introducing new lean manufacturing processes or continuous improvement software.
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Step Up To GMP Manufacturing Or Outsource To A CDMO
6/1/2022
Explore key factors to help you determine which strategy best suits your process, product, and team, as well as some general considerations and tips for succeeding in GMP manufacturing.
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Handling & Processing Of Potent Compounds: A Holistic Approach
5/5/2017
The topic of potent compounds may seem obscure; however, it touches virtually every aspect of the biopharmaceutical business, from selection pressure in media to antibody-drug conjugates (ADCs). Every chemical and biological compound we work with has an MSDS (material safety data sheet) and an OEL (occupational exposure limit), which dictate how we must handle the compound and bring to the forefront issues of personnel safety and environmental impact that we must address in our manufacturing plants. When designing a process involving any potent compound, there are three aspects we must address directly: facilities, processing equipment, and people.
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FDA Inspection Preparation: SOPs, Process Maps, And Gap Analysis
11/22/2021
Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.
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Moving Beyond Human Error In Biopharma Investigations And CAPA Programs
11/16/2020
Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.
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Stability Chambers: Testing, Equipment, And Uses
3/7/2023
Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
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Vaccine Capacity Musical Chairs
In the past six months, I’ve spoken to more vaccine developers than I have in the previous eight years, all of them searching for production capacity. Has the music stopped? Is it time to grab a chair?
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Why Biosimilar Makers Should Pay More Attention To U.S. State Governments
5/1/2018
A critical mechanism in the U.S. constitutional framework is often overlooked in a larger public affairs strategy — the right of a state to govern itself in most aspects. This article conveys the importance of shifting resources from the federal campaign efforts to a more local effort to ensure biosimilar success.