Bioprocessing Application Notes & Case Studies

1. Easy Perfusion For Anchorage-Dependent Cell Culture 1/13/2020

   Anchorage-dependent cells, such as Vero cells, are widely used as a platform for viral vaccine production. This application note demonstrates an excellent platform for high density Vero cell culture.

2. Satisfying Aggressive Timelines With A Simplified Supply Chain For Drug Delivery 1/10/2020

   To meet an aggressive timeline with a lack of resources, Kaleido Biosciences had to consider an alternative yet efficient route.

3. Process Optimization And Scalability Evaluation Of Pellicon® Capsules For Single-Pass Tangential Flow Filtration Of mAb-Based Biomolecules 1/7/2020

   SPTFF has been successfully implemented between unit operations throughout the downstream production process of biopharmaceuticals. Its value lies in the simplicity of operation as well as its small footprint and equipment requirement. This document describes the principles of SPTFF and how to determine operating conditions to achieve the target concentration factor with single-use Pellicon® Capsules.

4. Scale Your Bioproduction With Large Format High-Flow Connectors 1/3/2020

   Looking to scale up your liquid bioprocessing and decrease transfer times? Learn how high-flow, genderless, large format connectors make scale and efficiency easy and reliable.

5. Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies 12/26/2019

   The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

6. Managing Clinical Ancillary Supplies At Global Scale 12/26/2019

   Clinical ancillary management expertise helps biopharma company oversee a large, global trial from start through finish.

7. Scalable Freeze And Thaw Platform For Pharmaceutical Bulk Drug Substance 12/19/2019

   Did you know that slow freezing kills up to 20% of the protein solutions in biopharmaceutical liquids? This case study shows how fast freezing with a plate freezer reduces the risk of cryoconcentration dramatically.

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

   Quality by Design (QbD) is well established in the pharmaceutical industry for manufacturing processes, including active pharmaceutical ingredients and drug products. The knowledge obtained during development can establish the design space and determine suitable process controls. The novelty of the multivariate approach over the traditional one-factor-at-a-time (OFAT) type of study is the ability to evaluate both the individual factor effects and the factor-factor interactions that can also be significant. In this case study, a QbD approach was used to solve a high-performance liquid chromatography (HPLC) analytical method problem where impurity peaks had shifting retention times making identification and quantitation problematic.

9. 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.

10. Zydis® ODT Provides Better Treatments 12/18/2019

    Discover how Catalent's oral drug delivery offerings can help get your molecule to market faster. In this case study, learn the many benefits of our product offerings.