Outsourced Pharma App Notes & Case Studies

  1. A Statistical Approach To Expanding Production Capacity

    Contract manufacturer DSM Biologics at its current good manufacturing practices (CGMP) facility in Groningen, The Netherlands provides services for clinical development and commercial production based on mammalian cell culture technology. 

  2. Challenges Of Pharmaceutical Temperature Control Distribution

    A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, orphan drug product. 

  3. Outsourcing In The Pharma Industry – Experience, Expertise And Enthusiasm

    2012 will be regarded by many commentators as one of the most challenging years in the pharmaceutical industry’s history, due in no small part to numerous products facing patent expirations and increased global competition.

  4. E. coli Growth Dab Expression In Single-Use And Stainless Steel Fermentors

    This application note describes the performance of the Xcellerex™ single-use XDR-50 MO stirred-tank fermentor in an E. coli domain antibody (Dab) production process developed for a stainless steel fermentor. Cell growth, cell density, and Dab expression levels were assessed and compared between the two production vessels. The results show that the performance of the XDR-50 MO fermentor is comparable with that of the reference stainless steel fermentor.

  5. Managing Change Control To Comply With FDA And EU Regulations

    When properly implemented, change control is a potent force for improving the efficiency and effectiveness of a quality system. Many organisations find change control management to be a major problem because of the extensive documentation it generates, and the difficulty of managing the large number of interrelated elements and departments that are often involved.

  6. Manufacturing Spray-Dried Dispersions: Process Control Strategies

    This paper broadly describes a model-based SDD product development methodology as well as a control strategy that is based upon fundamental understanding of the formulation and the process.

  7. Pharmaceutical Development For ADCs: Not As Simple As ABC

    Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. 

  8. How To Survive An FDA Audit

    Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

  9. 6 Myths About Biocatalysis Every Manufacturer Should Ignore

    By dispelling the myths associated with biocatalysis, a manufacturer can reap the benefits of this technology, providing a route to greener, safer chemistry that delivers a higher overall yield.

  10. How A Leading Sponsor’s Metrics Were Exceeded For Global Vaccine Enrollment And DB Lock

    A leading pharmaceutical company contracted with INC Research/inVentiv Health Clinical to conduct a large global vaccine study involving more than 900 elderly subjects, all of whom were 68 years of age or older, at more than 50 study sites.