Biosimilar White Papers

  1. 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.

  2. RFID-Based Unit-Level Traceability: Could It Be The Key To Operational Excellence For Fill-Finish Lines? 9/5/2023

    Radio frequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

  3. 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.

  4. 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.

  5. 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).

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

    Conducting stability studies is a critical aspect of the drug development process. Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.

  7. 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 insights from scientists and R&D. Discover how cell therapy manufacturers can combat these costs.

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

    We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.

  9. Inspection Of Injectable Products For Visible Particulates 8/8/2023

    Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.

  10. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.