Biosimilar White Papers
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2024 Global Biopharma Sustainability Review
9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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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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The Advantages Of A Blended Learning Approach In Operator Training
5/30/2024
Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
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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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A Scalable Single-Use Two-Step pDNA Purification Process
3/6/2024
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.
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Innovation In Filtration
3/18/2025
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
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Biologics Technology Transfer Guidebook
2/26/2025
Explore why technology transfer is a critical component in mammalian biologic drug development and manufacturing with the essential guide to biologics tech transfer that covers key strategies, best practices, and critical considerations.
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COGs Process Economics For Autologous Cell Therapy
8/11/2023
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and additional insights. Discover how cell therapy manufacturers can combat these costs.
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Manufacturing Challenges With High Concentration Biologics
3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.
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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.