Industry Insights

  1. Quality Metrics: How To Add Value And Meet The FDA's Expectations

    Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. 

  2. Cold-Chain Fully Automated Assembly and Labeling of Pre-Filled Syringes for Clinical Trials

    Cold is undeniably the new normal for the biopharmaceutical industry. By 2020, greater than half of bestselling drugs will be cold-chain products, most of which are injectable.

  3. Phase II And Phase III Studies Standard Protocol A Template For Success?

    The ultimate goal of a template is to help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed.

  4. Meeting The Challenges With Complex Biomolecules In Modern Vaccinology

    Vaccine development and manufacture is one of the most challenging tasks within biopharmaceuticals today.

  5. Simplifying Recombinant Protein Production

    Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls. 

  6. Determining The Right Type Of Biomanufacturing Capacity

    In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.

  7. With Serialization Mandate Looming, Is Your Data Management System Ready?

    By November 2017, pharma companies must be able to send each product’s transaction information, transaction history, and transaction statement (collectively known as T3 documentation) electronically. 

  8. 5 ADC Manufacturing Challenges You Need To Know

    Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.

  9. Is Your Complex Formulation Process Set Up For Success?

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.

  10. Autologous Cell Therapies At Crossroads With FDA: What To Do Now?

    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?