Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Gap Analysis Fundamentals To Maintain Forward Progress 9/16/2020

    Gap analysis—defined as the process of reviewing all the available information for a candidate product to assess current development status, identify potential gaps in information, and the subsequent steps required to develop a strategy to fill those gaps a fundamental and ongoing exercise. In a recent The Business Of Biotech podcast Dr. Valenzuela,  CEO at Andes Biotechnologies, was joined on the podcast by Cristian Hernández-Cuevas, COO at Andes. Their collective reflections and advice on gap analysis execution provides real-world guidance for the leaders of emerging biopharma organizations.

  2. Embracing Biosimilars, They Are Here To Stay 10/10/2018

    The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.

  3. Autologous Cell Therapies At Crossroads With FDA: What To Do Now? 7/25/2017

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

  4. A 15-Minute Guide To Clinical Trial Document Management And The eTMF 5/30/2013

    At the Drug Industry Association’s (DIA) annual meeting held in June 2012, the TMF Reference Model Working Group released TMF reference model 2.0, which included significant updates from the group’s 2010, 1.0 release.

  5. Navigating IND Submissions In China

    Lonza Biologics recently presented a webinar on how to navigate the complexities of submitting a clinical trial application in China.

  6. The Importance Of Assessing And Mitigating Immunogenicity Potential

    Immunogenicity assessment is an area where "standard" in vivo toxicology assessments might lack clinical relevance. Get an expert view on early immunosafety assessment challenges and risk mitigation strategies.

  7. Soluble Versus Insoluble Expression In Microbial Fermentation

    Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?

  8. A Stepwise Approach To CMC Planning For A Biologics License Application

    Lonza understands the challenges of designing a CMC strategy and has developed a structured and stepwise approach to planning that is tailored to our customers’ product, process, and risk tolerance.

  9. A 15-Minute Guide To Compliant Document Management For Life Sciences

    Life Sciences quality and manufacturing organizations face three critical industry forces:  increasingly stringent regulation; globalization; and virtualization of supply networks.

  10. A 15 Minute Guide To Efficient And Compliant Management Of GMP Controlled Documents

    Life Sciences quality and manufacturing organizations face three critical industry forces: increasingly stringent regulation; globalization; and virtualization of supply networks.