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Pharmaceutical Manufacturing and Packing Sourcer
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A pharmaceutical product’s ability to perform its purpose depends on its quality; the user expects the product to be safe, therapeutic and completely fit for function. To meet these criteria, it needs to be intrinsically stable, free of contamination and must reproducibly deliver the therapeutic benefit claimed on the label or in the product information leaflet to the consumer over the period of its shelf life. Such a product is said to deliver its quality through its design, hence the phrase ‘Quality by Design’ (QbD). QbD focuses on integrated product development, commencing at the concept stage (1). These principles have been adopted by the FDA for the discovery, development and manufacturing of drugs and have been developed further for biopharmaceutical products (2,3).
When a product is developed with raw material selection in mind, designing quality and removing formulationassociated risks are key considerations. To this end, using the best materials available is crucial to help manage these aspects of chemistry. Depending on how the drug is to be administered (topically, orally or parenterally), raw material choices and their attributes need to be deliberated, especially where key ‘natural’ materials are to be used. A control strategy needs to be developed for the entire process, including tight supervision on the excipients’ specifications, to ensure consistent quality and product stability over its shelf life.
As such, excipient selection plays a key role in determining the performance of a drug – not only in delivering the efficacy required, but also maintaining this over the product’s lifetime.
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News and Press Releases |
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TheVax Genetics Vaccine CO., Ltd and Biotechpharma UAB to collaborate on cGMP production of THEVAX HBV Vaccine
VILNIUS, Lithuania and TAIPEI, Taiwan, April 30, 2018 /PRNewswire/ --
TheVax Genetics Vaccine CO., Ltd (6567.TWO) and Biotechpharma UAB have
entered into a manufacturing agreement to produce THEVAX HBV vaccine for
first-in-human clinical trials.
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Delivering Fit For Purpose Biomanufacturing CHO Cell Lines
Fujifilm Diosynth Biotechnologies
The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
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Industry Events |
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BioPharm America 2018
5-6 September 2018, Hynes Convention Center
BioPharm America™ is a unique partnering event that forms the nexus of discovery and realization. Startup companies, established biotech and entrepreneurs from academia attend in search of finance, pharma and development partners. The event format highlights innovation and promotes new business relationships by bringing dealmakers from the life science ecosystem together to engage and de-risk the enormous task of drug development.
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