Industry Insights

  1. 3 Steps To Better Extractables & Leachables Studies

    There is no shortage of guidance for conducting extractables and leachables studies. The trick is aligning standards that overlap.

  2. Tufts Study Uncovers The Economic Advantage Of Single-Source Drug Development And Manufacturing

    With patient care at the forefront, it is critical to assess the economics of both outsourcing models and ensure the one you select provides the most efficient path to commercialization. This was the purpose of a recent study by the Tufts Center for the Study of Drug Development (CSDD), which compared cycle times and development economics between multi- and single-source CDMO models.

  3. Real-Time Monitoring Of Pharmaceutical Shipments

    Supply chain visibility is ever paramount to the success of your shipping program. What criteria should you consider when evaluating solution providers offering monitoring devices whose data can be accessed from the provider’s software platform in real-time?

  4. The Pharma Trends You Need To Know: A CDMO’s Perspective

    Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.

  5. Characterize Drug Substance Properties Early To Optimize Drug Formulation

    Drug substance characterization is critical to drug product formulation but characterization and formulation are often not integrated during drug development. 

  6. Thinking Outside Of The Freezer: DNA And RNA Storage

    While ultra-low temperatures are the current state-of-the-art solution for biospecimen storage, ambient storage is an interesting option and could be superior in certain limited situations. For many types of samples, it’s possible that we will always have to use ultra-low temperatures for long-term storage. For other sample types, such as DNA and RNA, there are alternative solutions.  

  7. Why Early Investment In A Scalable Manufacturing Process Is Critical

    The failure of drug compounds in mid- to late-stage development is far more common than anyone would like it to be. Only about 30% of compounds successfully transition from Phase II to Phase III.

  8. Detecting Bad Quality Culture – A Guide For Small And Virtual Companies

    Small and virtual biotech and pharmaceutical companies rely heavily on partners to advance their development programs. This article offers insider tips for spotting when quality culture has gone bad.

  9. Modular Approaches For Diverse Molecules: Reinventing Smart Bioprocessing

    Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.

  10. Biopharma’s Talent Crunch: How To Gain And Retain Skilled Labor

    What strategies should your company consider for recruiting, training, and retaining qualified candidates in order to remain competitive in a burgeoning biopharma market?