Biosimilar White Papers

  1. 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.

  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. 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. 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.

  5. 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.

  6. Designing Successful Viral Clearance Studies 12/23/2021

    A review of studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.

  7. 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.

  8. Establishing Analytical Methods For mRNA-Based Therapies 6/13/2023

    Here, we provide a detailed description of assays for sequence identification and LNP composition, two CQAs of mRNA-LNP products, that support the development of safe and effective mRNA therapies.

  9. 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.

  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.