Industry Insights

  1. Key Challenges In mRNA Manufacturing 7/11/2024

    Manufacturing mRNA products is a complex and challenging process that requires careful consideration at each stage. Learn more about the challenges and intricacies involved.

  2. How Will Medicare's International Pricing Index Model Affect Biosimilars? 12/18/2018

    CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.

  3. Leveraging Digital Solutions To Reshape The CDMO Experience 1/8/2025

    CDMO customers consistently state that access to near real-time data is crucial to their ability to make timely, informed decisions, especially during early development.

  4. Solid Form Strategies For Increasing Oral Bioavailability

    Optimizing a drug’s solid form can improve its solubility and bioavailability when further molecular modifications are prohibitive.

  5. Qualifying Working Cell Bank Replenishment 9/6/2022

    Cell banks represent the fundamental starting substrates for biological drug substance/drug substance intermediate manufacturing. The availability of well-characterized cell banks is imperative to ensure drug product supply. This article shares regulatory tips for cell bank registration and regulatory considerations when replenishing a working cell bank.

  6. Modular And Single-use Tech Driving The Future Of Biomanufacturing 11/14/2023

    BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.

  7. Three Imperatives To Make Regenerative Medicine An Everyday Reality 7/18/2022

    Three imperatives that will help make regenerative medicine part of everyday medicine explained.

  8. Industry Trends In Biologic Formulations

    Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs, and favorable government regulations.

  9. Maybe Biosimilar Applicants Should Dance After All 6/30/2020

    The decision to engage in the BPCIA patent dance with a reference product sponsor is rarely black and white. Early dismissals in cases like Eagle v. Slayback and Amgen v. Coherus are just one factor a biosimilar applicant should consider.

  10. Successful Regulatory Submission Via The Trifecta Of Awesomeness 1/17/2025

    Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.