Industry Insights

  1. 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?

  2. Complex Molecule Development: Early Considerations To Avoid Failing Later?
    1/26/2018

    How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.

  3. Let The Molecule Decide
    11/2/2017

    Formulation techniques and technologies can become more habit than science, but a single technology does not work for all compounds. Each new drug is unique and deserves a fresh approach to formulation.

  4. The Future Is “Cloudy” For Data Integrity In Life Sciences
    11/29/2016

    Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.

  5. What You Need To Know About Continuous Processing
    2/1/2018

    There is a lot of interest around continuous biomanufacturing, but could a hybrid of batch and continuous unit operations be the best solution for your process train?

  6. Simple Steps To Maintaining Your Chromatography System
    1/21/2017

    There are simple and straightforward chromatography maintenance tips involving sample preparation, buffers, columns and the overall system to keep your experiments humming along.

  7. Pulse Check: How To Assess Your In-House Biomanufacturing Capabilities
    6/18/2018

    By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.

  8. Business and Cultural Considerations When Managing Clinical Supplies for Asia-Pacific Studies
    2/8/2018

    In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.

  9. Speaking The Regulatory Language
    8/16/2016

    The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for MilliporeSigma, to explore the interplay of emerging markets and regulatory harmonization.

  10. Jumpstart Cell & Gene Therapy Commercialization With SUT Learning
    5/21/2018

    Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. In some ways,  will cell and gene therapy manufacturing be similar to biopharmaceutical manufacturing? What are the key differences and gaps in learning?