Contract Pharma Manufacturing White Papers & Articles
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Nasal Vaccine Development, Manufacturing, And Device Selection
7/11/2023
When developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.
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Spray Drying To Enable New Inhaled Drug Products
7/11/2023
The formulation and spray drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, a biologic, or rapid onset therapeutic.
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Assessing Reliability, Confidence, And Batch Variation In PPQ Runs
6/29/2023
Examine the procedures and benefits of two statistical methodologies and how new technologies are requiring a risk-based approach to calculate the necessary number of PPQ runs.
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Successful Planning: Process Liquid & Buffer Preparation
6/23/2023
Obtain an accurate total cost of ownership assessment through understanding common operational inefficiencies, risks, and financial burdens associated with process liquid and buffer preparation.
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The Business Case For Pharmaceutical Continuous Manufacturing
6/2/2023
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
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The Growth Of Sterile Injectables
6/1/2023
Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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CDMO Management for Sponsors — Part 2: Handling SOPs, Multiple Partnerships, and M&A Disruptions
5/30/2023
Day-to-day discussions between technical teams and regular brainstorming/exchange-of-information meetings are commonly understood to be vital to a partnership — ensuring the sponsor and vendor understand each other’s long- and short-term priorities — but problem-solving and mediation are equally critical communication skills.
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CDMO Management for Sponsors — Part 1: Identify Partners and Nail Project Kickoff
5/30/2023
Identifying an appropriate CDMO partner and establishing relationship structure/expectations early is an intrinsic part of leveraging the CDMO to provide the sponsor a competitive advantage. A good partner blurs the line between third-party service and extension of your company.
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Efficient, Large-Scale Transfection Of T-Cells Using Flowfect® Technology
2/26/2023
The objective of this study was to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post-transfection growth using Kytopen’s Flowfect® technology.
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Importance Of Assessing Mannitol Crystallinity In Lyophilized Drug Products
2/15/2023
Drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.