Biosimilar Regulatory solution center

  1. EMA Updates Guidance On Inhalation And Nasal Product Quality 5/29/2024

    The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.

  2. A Synergy Of Excellence: Partnership During Unprecedented Times 5/28/2024

    Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.

  3. Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies 5/24/2024

    The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.

  4. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  5. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

  6. Strategies For Ensuring Virus Bank Manufacturing Success 4/29/2024

    Learn about the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks.

  7. Integrating Quality Processes And Documentation After A Merger 4/25/2024

    If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.

  8. 5 Areas To Focus Your QRM Strategy For Sterile Drug Products 4/24/2024

    Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.

  9. Single Use In Biopharma: Beyond Savings & Sustainability 4/17/2024

    SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. We dove headlong into those issues and more with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.

  10. Tips For Viral Vector Production 4/16/2024

    Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.