Downloads

  1. Medium Preparation For Single-Use Fermentation
    11/17/2017

    Single‑use fermenters are becoming an increasingly viable alternative to stainless steel, offering less time is spent on equipment preparation and qualification prior to start-up as well as routine maintenance and requalification of the equipment.

  2. Single-Use Stirred Tank Fermentor System Performance Comparison
    11/17/2017

    The process design proven for one fermentor system is not always directly transferrable to other system formats without adaptation. Here, we compare the performance of the XDR‑500 MO fermentor with the XDR‑50 MO system.

  3. 7 Surefire Ways To Motivate A Life Science Consultant
    11/17/2017

    Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.

  4. ÄKTA Readyflux Single-Use Filtration System Datasheet
    11/15/2017

    ÄKTA readyflux is an automated single-use filtration system for pilot- and small-scale manufacturing. The system is intended for crossflow (also called tangential flow) filtration applications in both upstream and downstream workflows.

  5. Evaluation For Ultrafiltration To High Protein Concentration Using TFF
    11/15/2017

    This automated single-use filtration system for pilot- and small-scale manufacturing features a single-use flow path that addresses the bioburden challenge, reducing the need for cleaning to shorten batch changeover time.

  6. Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing
    11/15/2017

    Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.

  7. Millistak+® HC Pro Datasheet
    11/14/2017

    Millistak+® HC Pro (high capacity synthetic media) is a family of synthetic depth filters providing a cleaner and more consistent depth filtration media over current diatomaceous earth (DE) and cellulose (CE) based filter offerings. Multiple media grades are available for primary and secondary clarification as well as downstream filtration applications.

  8. Sterile injectables
    11/14/2017

    Pfizer CentreOne™ is a global CDMO that manufactures custom APIs, sterile injectables and highly potent solids; and is a supplier of steroid and hormone APIs. This brochure provides an overview of Pfizer CentreOne’s capabilities related to sterile injectables fill-finish. Download it to learn more about their expertise in complex biologics, controlled substances, lyophilization, and sterile suspensions.

  9. Highly Potent Solids
    11/14/2017

    Pfizer CentreOne™ is a global CDMO that manufactures custom APIs, sterile injectables and highly potent solids; and is a supplier of steroid and hormone APIs. This brochure provides an overview of Pfizer CentreOne’s capabilities related to the manufacture of highly potent oral solid dosage forms. Download it to learn more about their specialized technologies, containment expertise, and deep technical and commercial know-how.

  10. APIs and Intermediates
    11/14/2017

    Pfizer CentreOne™ is a global CDMO that manufactures custom APIs, sterile injectables and highly potent solids; and is a supplier of steroid and hormone APIs. This brochure provides an overview of Pfizer CentreOne’s APIs and intermediates that they use for their own branded medicines. Download it to learn more about their expertise in manufacturing cortico-and hormonal sterorioids, prostaglandins, and antibiotics.