Production Featured Articles

  1. Managing Risks With Potent Pharmaceutical Products 7/2/2019

    Managing the risks associated with potent compounds requires a knowledgeable team as well as the design and implementation of an effective safety program.

  2. Keeping Pace With Increasing Biopharmaceutical Manufacturing Demand 6/21/2019

    Today’s biologics pipeline is healthy, but forecasts indicate growth so robust the industry risks being ill-equipped to meet demand. Will contract manufacturers to rise to the demand challenge?

  3. Maintenance 4.0: The Next Revolution In Bio/Pharma Manufacturing 6/21/2019

    The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.

  4. Optimize Your Lyophilization Process Using Minimal Drug Substance 6/18/2019

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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.