Phase 1
Phase 2
Phase3
Preclinical
Early Drug Development Strategies for Clinical Success
Summary: Every clinical study is different, each with its own unique characteristics and requirements. The optimal time to begin planning a clinical supply strategy is while the study...
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Phase 1
Phase 2
Phase 3
Comparator Drug Sourcing Solutions - Catalent’s Network Effects
Summary: A well-known, mid-size, multi-national pharmaceutical company needed a large supply of comparator drug, in order to begin comparative clinical trials for a rare disease. In addition to quantity, the comparator drug must have an expiry-term long enough for the client to complete the multi-year clinical trials...
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Preclinical
Achieving Faster Timelines and Higher Titer in Antibody Expression When Combining GPEx® Cell Line Development Technology with the Beacon® Platform for Clonal Cell Line Selection
Summary: This case study explores Catalent’s unique GPEx® technology for stable gene product expression with Berkeley Lights, Inc.’s (BLI) Beacon® instrument for clonal selection.
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Commercial
Phase 2
Phase 3
Leveraging Catalent's Integrated Network to Accelerate Spray Drying and Tableting Scale-Up
Learn how a biopharmaceutical company partnered with Catalent to develop and manufacture a commercially-viable, patient-friendly, stable tablet for a program intended to treat a disease that has unmet medical need.
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Phase 1
Phase 2
Phase 3
Preclinical
Planning Ahead: Using Phase 1 to Anticipate Phase 2 Clinical Supply
Learn what clinical sponsors should look for when assessing integrated services and potential providers.
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Phase 1
Phase 2
Phase 3
Preclinical
Planning Ahead: Using Phase 2 to Anticipate Phase 3 Clinical Supply Challenges and Solutions
While clinical studies are in Phase 2, it is important for sponsors to be prepared for any Phase 3 challenges that might arise. Understanding what resources are available is key to being ready for Phase 3 before it even begins.
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Commercial
Phase 1
Phase 2
Phase 3
Preclinical
Accelerated Pathways from Development to Clinic and Market
Summary: In this executive summary, industry experts share case studies of how they’ve adapted to increasingly expedited regulatory reviews.
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Commercial
Phase 1
Phase 2
Phase 3
Preclinical
Strategies For Speeding Time To Clinic For Biotherapeutics
Summary: As the need for accelerated biopharmaceutical development around the world continues to grow, companies are facing complex challenges that need to be overcome to remain competitive for increasing process productivity...
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Phase 1
Phase 2
Phase 3
Managing Risks to Time Critical Product Imports at Clinical Supply Depots
Summary: A Catalent customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-Catalent facility in Europe to a Catalent-managed and audited depot in Israel. With the protocol based...
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Phase 1
Phase 2
Phase 3
Preclinical
Expediting Path to Clinic with OptiForm® Total Supply
Summary: MGB Biopharma, a biotech company based in Scotland, U.K. was developing a new class of anti-infective medicine based on Minor Groove Binder compounds. Learn how Catalent provided integrated formulation...
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