Outsourced Pharma App Notes & Case Studies

31. Distributed Biobanking: An End To End Solution For FFPE Tissue Block Management 3/27/2019

    From a historical perspective, there are millions of FFPE tissue blocks in storage and in use today. Most storage process work well for small numbers of samples, but is quickly overrun when thousands of blocks begin to accumulate. A new end to end system has been developed and implemented in several locations worldwide to address the issues encountered with FFPE block storage, retrieval and restocking.

32. Purifying Plasmid DNA Using A Modern Chromatography Resin 2/5/2020

    Through an industry collaboration, Cobra and GE were able to combine their expertise and experience and create a solution to meet the rising demand for high quality plasmid DNA.

33. The Transparent CDMO: Maintain Autonomy In Biomanufacturing Partnership 7/6/2018

    Complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

34. Cell Therapy Manufacturing Under GMP - How And When To Get Started 5/2/2019

    Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology they concurrently evaluate whether or not to manufacture the therapies onsite. Here is a guideline of how and when to get started.

35. Determination Of Adenovirus Concentration Using Surface Plasmon Resonance 9/10/2018

    The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.

36. Quality By Design Approach To Analytical Method Optimization 12/18/2019

    A QbD approach solved a high-performance liquid chromatography analytical method problem where impurity peaks had shifting retention times making identification and quantitation problematic.

37. Comparing Continuous And Batch Processing In Downstream Purification 6/10/2019

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

38. Industry Trends In Clinical Development Technology 3/18/2020

    There’s no question that technology is continuously becoming more embedded throughout the clinical development process. The use of electronic data sources is no exception. More systems, processes, files, storage, and approvals are moving away from paper-based methods and toward applications that utilize electronic sources of data.

39. Zydis® Bio Technology, Grazax® & Grastek®: Revolutionizing Allergy Therapy 12/18/2019

    ALK-Abelló is a global research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies. Before ALK-Abelló partnered with Catalent, all marketed allergen immunotherapies were delivered by injection, resulting in a limited patient population and reduced patient adherence. Catalent worked with the client to apply Zydis Fast Dissolve Technology to their therapy, bringing a vastly superior product to market.

40. Innovative, Flexible, And Time-Sensitive Packaging Solutions 9/19/2018

    Given the rapidly changing landscape of today's trials, if sponsors wish to succeed, they must remain vigilant - attending to every detail of the process. Learn how several sponsors achieved success through these case-study examples.