Biosimilar Manufacturing solution center
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Biopharma Manufacturing For Advanced Therapies: A Panel Discussion
9/1/2023
Explore highlights from a panel discussion focused on improving biomanufacturing processes to help ensure the next generation of advanced therapies is both accessible and affordable to patients.
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Enhancing Security Of Supply Of Cell Culture Media With Single-Use Bags
9/1/2023
Biopharma manufacturers continue to face a challenging supply and demand landscape. Learn how Cytiva secured its single-use bag supply with in-house manufacturing of liquid media bags.
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5 Best Practices For Responding To FDA Form 483 Inspection Observations
9/1/2023
How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.
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Sterile Filtration And Quality Risk Management
8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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4 Ways To Gain A Competitive Edge In This Bio/Pharma Talent Shortage
8/25/2023
It’s no secret that finding pharma/biotech manufacturing talent is challenging, and the lack of workers is having a negative impact on productivity and growth. Here are four effective strategies for recruiting, training, educating, and retaining your workforce.
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Lowering The Lipid Barrier To RNA-LNP Therapeutics
8/22/2023
Industry experts discuss current and future trends, formulating successful lipid compositions and navigating the constantly evolving genomic medicine landscape.
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Fast Track RNA-LNP Drug Development By Lowering The Lipid Barrier
8/21/2023
Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.
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Vendor/Supplier Management To Maintain A Drug’s Safety Profile In End-To-End Supply Chain Planning
8/17/2023
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.
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FDA Issues Second DSCSA Warning Letter — What Does This Mean?
8/16/2023
In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.
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CGMP Requirements For Automated Facility Monitoring Systems
8/15/2023
To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.