Search results for " process"
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Manufacturers Struggle with Breakthrough Drug Development
Such designation brings considerable FDA assistance in developing accelerated test protocols and in speeding an application through the review process. The designation also plays well on Wall Street, …
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Comparing Protein A Resins for Monoclonal Antibody Purification
As a consequence, downstream processing must accept and handle higher titers of mAbs in harvested cell-culture fluid (HCCF), and vendors of mAb purification technologies must develop chromatography re…
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Webinar: Intensifying downstream bioprocessing with continuous technologies
In this webinar we will explore common bottlenecks in downstream processing and look at continuous processing solutions that can further intensify the monoclonal antibody (mAb) platform.
We will di…
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Moving Biosimilars Forward in a Hesitant Market
… A better model would be one where any biosimilar that’s approved, that goes through the rigorous approval process, by regulators in the US or elsewhere is automatically deemed to be interchangeable …
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Right the First Time: Bioreactor Scale and Design Translation
Cell culture processes need to operate in a design space where the oxygen supply and carbon dioxide removal can match cellular metabolism. In addition, prohibitive high shear stress and high gas flow …
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Webinar about a new affinity chromatography technology for recombinant proteins
• Process developers who need faster and smarter ways to develop processes for recombinant proteins that don’t have an affinity binding partner.
REGISTER TO WATCH THE WEBINAR NOW
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Program finalized for the 6th HTPD and smart PD conference
Talks will cover everything from in silico PD and mechanistic modeling, HTPD approaches to chromatography resin screening and optimization, process characterization of gene therapy viral vectors to es…
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Report from the 12th Plasma Product Biotechnology Forum
With moderate investment Biopharma Plasma have constructed a fractionation facility to process up to one million liters of plasma plus eight modern plasma collection centers. Most impressively, they h…
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Developing a Robust Bioprocess Using Mechanistic Models
The robustness of the manufacturing process has to be validated in order to bring a new biological drug to market.
Regulatory agencies such as the Food and Drug Administration (FDA) and Euro…