Biosimilar White Papers

  1. Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster 3/24/2023

    Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

  2. Taking Charge Of Your Stability Program 10/5/2022

    Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

  3. Process Development Considerations For RNA-LNP Therapeutics 9/13/2022

    Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).

  4. Quality by Design (QbD) for Adeno-Associated Virus (AAV) 10/14/2021

    CMC is but one obstacle to gene therapy regulatory approval. Here we review a framework for QbD assessment of AAV products within the Chemistry Manufacturing and Controls documentation.

  5. Key Stages In mRNA-Based Therapeutic Development 9/13/2022

    Learn how planning a product development strategy early on with a technology partner who has deep expertise and technical knowledge of genomic medicines can address uncertainties from the outset.

  6. Manufacturing Custom CDM With Precision Accuracy 4/10/2023

    Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.

  7. Orthogonal Methods To Understand And Define CQAs Of AAV Therapies 2/24/2023

    An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.

  8. A Risk-Based Approach To The Development Of An Injectable Combination Product 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.

  9. Regulatory Considerations For Alternative Microbial Methods 2/28/2022

    This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.

  10. 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.