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

  1. 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.

  2. The Biomedicine Revolution 11/2/2017

    Personalized medicine has the untapped potential to unlock value for both patients and providers. However, biomanufacturers face major obstacles in drug development, such as increasing regulatory oversight, longer development times, and a growing public focus on drug pricing. This e-book outlines some of those struggles as well as highlights the successes of those working to advance the personalized medicine industry.

  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.