Biosimilar Regulatory solution center

  1. 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.

  2. 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.

  3. 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.

  4. FDA Publishes Final Guidance On Reporting Listed Drug Amounts 4/10/2024

    Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.

  5. Quick Takes From Takeda Austria's Annex 1 Rollout 3/25/2024

    At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.

  6. Navigating Grades And Sources Of Materials In Drug Manufacturing 3/22/2024

    From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.

  7. Fine-tuning Analytical Development Strategies For Every Phase 3/22/2024

    Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.

  8. Top 10 Biologics Approved In 2023 3/20/2024

    In 2023, 18 new biologic drugs were approved by the EMA and 34 by the FDA. Dive into the 10 most important drugs that cover unmet medical needs and have the potential to revolutionize medical practice.

  9. A Structured Approach To Regulatory Information Management Vendor Selection 3/13/2024

    Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

  10. Navigating China's Biologics Approval And Accelerated Pathways 3/8/2024

    Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.