Production Featured Articles

  1. How To Best Optimize Your Lyophilization Process Using Minimal Drug Substance
    6/18/2019

    Scale-up and technology transfer of lyophilization processes remain a challenge, but recent advances in steady-state computer modeling and bench-scale lyophilization practices are driving process optimization with minimal drug substances.

  2. Equipment Change Control For GMP Production Facilities — How To Start
    6/5/2019

    While many may conceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect.

  3. Is Continuous Manufacturing Right For Your Drug?
    5/30/2019

    Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.

  4. Answering Today’s Pharma Dilemma Of Build Or Buy
    5/22/2019

    A new business and operating model may address the build or buy dilemma, offering an innovative and agile way to manage demand uncertainty and reduce the risks associated with early investment decisions.

  5. The Value Of Digital In Biopharma
    5/10/2019

    By working together across the biopharma industry, digital technology can be leveraged and data science can reengineer key elements of the drug manufacturing process to ease commercial scale-up.

  6. Translating Biopharma Knowledge To Cell And Gene Therapies
    5/6/2019

    Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

  7. Grifols New Manufacturing Facility Provides Contract Development And Manufacturing Solutions For Recombinant Proteins
    5/3/2019

    Grifols' Consolidated Manufacturing Facility (CMF) is a flexible, multiproduct facility with available manufacturing capacity that created an opportunity to leverage their existing technical expertise and commitment to quality to provide contract services to biopharma companies as a recombinant protein CDMO and support the development of innovative therapies. We recently spoke with Paul Magreta at Grifols about their new $80 million manufacturing facility in Emeryville, California, and the CDMO Services they offer. 

  8. Training Production Operators In Aseptic Technique: Common Pitfalls And How To Avoid Them
    5/2/2019

    Retraining an operator involved in a microbiological excursion is almost always part of the corrective and preventative action (CAPA), yet repeat excursions and deviations due to improper aseptic technique still routinely occur. So, why do some operators still have difficulty executing the task after completing such intensive training programs?

  9. Scaling Up Or Transferring Your API Manufacture? 3 Considerations To Manage Risk And Improve Efficiency
    4/29/2019

    Scaling or migrating active pharmaceutical ingredient (API) manufacturing requires careful planning and a strategic mindset. In this white paper, learn how to scale and migrate the right way.

  10. Incorporating Natural Hazards & Distributed Infrastructure Into Risk Management For Biopharma Operations
    4/25/2019

    Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.