Application Notes & Case Studies

1. 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.

2. 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?”

3. 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.

4. 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.

5. 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.

6. 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.

7. Considerations To Purchasing Low Cost Equipment In Cannabis Manufacturing 11/22/2019

   No one can deny that the cannabis industry is one to watch. Anyone looking to compete in the marijuana and CBD manufacturing business will need to secure process and packaging equipment necessary to produce these products on a commercial scale and with the expected quality. Learn how used process and packaging equipment for the marijuana and CBD industry can fill an immediate and growing need for manufacturing equipment.

8. Accessible Anywhere: How Pfizer Deployed The PI System™ To Enable Production Analysis Across The Organization 11/21/2019

   Pfizer’s Small Molecule Division in Groton, Connecticut, operational data was siloed and only available within the physical building, increasing manual work, hindering collaboration and creating data latency issues. To reach its goal of doubling the innovation success rate while decreasing time to market, Pfizer needed a new data strategy. Using OSIsoft’s PI System, Pfizer embarked on a journey to digitize the drug discovery process and create a single source of truth for self-service operational insights that are accessible anytime and anywhere.

9. Automated Cell Bleed Control In An Intensified SU Rocking Motion Bioreactor 11/20/2019

   Intensified processing increases the productivity of single-use facilities and decreases the manufacturing footprint. Here's how to optimize the approach.

10. Build Or Buy: 6 Advantages Of A Customizable GMP Environment 11/19/2019

    An alternative solution to the 'build or buy' decision is the use of readily available, pre-qualified GMP facilities which can be fully tailored to suit individual needs and budget.