Biosimilar White Papers
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The Dynamic Regulatory Environment Of Drug-Device Combination Products
11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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Establishing Commercial Manufacturing Services For ADCs
6/3/2024
Explore how one organization built upon 15+ years of experience and an extensive knowledge base of biologics manufacturing to establish commercial-scale ADC manufacturing capabilities.
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Considerations For Developing The Recirculation/Perfusion Process
6/6/2024
Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.
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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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Quantitation Of Monoclonal Antibodies In Serum
2/8/2024
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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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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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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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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A Risk-Based Approach To Injectable Combination Product Development
3/14/2023
Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?
4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.