Search results for " partnership"
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
The facilities, built in partnership with Cytiva, offer cGMP manufacturing based on mammalian cell culture technologies to meet customer demand for Phase II/III clinical trials. In addition, the singl…
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Biosimilars to Drive Modern Manufacturing Approaches
He and other leaders in the biosimilars field are looking for partnerships and alliances to help secure the best technology for providing large quantities of these follow-on therapies.
Manufacturi…
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Biosimilars: Making the Switch Comes with Challenges
Remsima, then marketed by Hospira in partnership with its developer Celltrion of Korea, won a national tender to supply it to all Danish hospital pharmacies that were able to switch patients to the pr…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
A few examples are BPOG’s Supplier partnership program (SPP), a change notification committee and co-establishing single-use system user requirements.
There is a lot of discussion on standardiza…
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Framing Biopharma Success in 2016
The search for external opportunities was a priority; more than half of the respondents said they are planning peer-to-peer research partnerships; 85% report that they plan to hire a contract research…
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Best Practices in Qualification of Single-Use Systems
Conclusion
The partnership between end user and supplier is essential to successfully implement SUS in manufacturing drugs to achieve success in implementation and continued operation, and to ensu…
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Taking a “Development-by-Design” Approach to Cell Therapies
In January, PCT entered a partnership with Invetech, an equipment design firm based in Australia, with offices in San Diego, to develop automated equipment for cell therapy manufacturing.
The two …
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Biopharma Advances Demand Specialized Expertise
The expanding capacity needs result in partnerships between clients and their contractors with the systems, experience, and expertise to achieve the quality and speed required, while meeting all regul…
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Modular Manufacturing Platforms for Biologics
PCMM systems, launched in partnership with Pfizer, GEA Pharma, and G-CON, are virtually factories within a pod. The first example of this type of unit, constructed to produce oral solid-dosage drugs, …
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Mechanistic Modeling: Does it Have a Future in Process Development?
Could you tell more about your experience?
A couple of years ago, CDER invited industry for partnerships for discussions on how to prepare an application using QbD. Then representatives of CBER app…