Bioprocessing White Papers
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Methods For Determining Equipment Capability Of Freeze-Dryers
10/16/2024
Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
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Leak Rate Testing for Freeze Dryers: A Scientific Approach
10/16/2024
Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.
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Factors To Consider While Selecting Stoppers For Lyophilized Vials
10/16/2024
Ensure the success and stability of your lyophilized products by choosing the right container-closure system — explore your stopper options, here.
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Considerations And Options For Prefilled Syringes
10/16/2024
Explore the benefits of prefilled syringes to enhance product convenience, reduce drug waste, and streamline your pharmaceutical manufacturing process.
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Best Practices In Formulation And Lyophilization Development: Proteins, mAbs And ADCs
10/16/2024
Discover how advancements in pharmaceutical freeze-drying are reshaping the process through better product understanding, precise process control, and innovations in equipment efficiency.
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Is Mannitol Hemihydrate Detrimental To Protein Stability?
10/16/2024
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
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Vial Breakage During Lyophilization: Root Causes And Mitigation
10/16/2024
Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
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Optimizing Safety Measures For rAAV Therapies
10/11/2024
Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk
10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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Avoiding The Pitfalls Of PQR
10/9/2024
Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."