Outsourced Pharma App Notes & Case Studies
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Getting CMC Right For Emerging Technologies
12/20/2023
Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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Optimized Processes: A Guide To Lyophilization Cycle Development
6/25/2024
Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.
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A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation
1/15/2025
Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.
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Closing The Duration Gap In FDA-Approved Long-Acting Contraceptives
7/17/2024
A gap exists between three months and three years in FDA-approved long-acting contraceptives (LACs). A microsphere formulation enables sustained release over a six to twelve-month period.
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Implementing A Disaster Recovery Plan
8/23/2024
When facing a malfunction, having an effective disaster recovery plan can make the difference between a swift fix, and losing your samples and time.
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Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel
10/19/2023
Here, we describe the design and performance of a degenerate PCR-based approach to broad virus screening that can be used in testing bulk harvest material derived from CHO cells.
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Lyophilization To Enable Drug Products Containing Labile Molecules
6/6/2025
Develop lyophilized formulations to overcome stability challenges and significantly extend the shelf life of sensitive therapeutic products.
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Long-Term Container Closure Integrity Testing Of Vial-Stopper-Seal Combinations
9/3/2024
The study was designed to investigate CCI over a period of 24 months at ambient, ultra-low and cryogenic temperatures for serum-stopper samples and at ambient temperature for lyo-stopper samples.
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Choosing The Right Tech To Optimize Processes And Reduce Costs For Therapeutic Proteins
3/25/2025
Discover how scalable and cost-effective manufacturing solutions can optimize your biopharmaceutical production, ensuring the successful commercialization of your therapeutic protein and broader patient access.
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Lentiviral Vector Production Using Single-Use Bioreactors
5/6/2024
Here, we outline a scalable and robust upstream process developed for LVV production of HEK293T cells and demonstrate how to expand HEK293T suspension cells.