Search results for " biologics" in Articles / App Notes
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture evolution
Current cell-culture processing has been optimized and has resulted in significantly higher cell densities compared to biologics manufacturing in the past. In the early 1990…
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Biopharma Seeks Balance
Moving from one technology process during scale up to another for manufacturing creates problems, noted Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, to the audienc…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
This week, the Process Development Forum talks to Dr. Neil Goss, an international consultant in biotechnology and plasma fractionation, past director of Research and Development at CSL BioPlasma, Aust…
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Process Development: What May Lie Ahead in 2018?
While only 22 new drugs were approved in 2016, FDA gave its thumbs up to 46 new drugs in 2017 (of which approximately one-quarter were biologics). The figures for all new drug approvals are in line wi…
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QbD Improves Cell-Culture Process Control
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
By Feliza Mirasol
Mar…
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Roadmap Leads to Innovative Biomanufacturing Strategies
Biomanufacturers are uniquely aware of the challenges faced during development and manufacturing of biologics and they are in the best position to communicate their needs to the suppliers and academic…
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ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance
Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.
By Feliza…
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Development of Purification for Challenging Fc-Fusion Proteins
All are at Patheon Biologics.
*To whom correspondence should be addressed.
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
…
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Downstream Processing for Cell-Based Therapies
Unlike the traditional manufacture of monoclonal antibodies (mAbs) and other biologics, the production and processing of cellular material forms the basis of the product for CGTs (1). As such, manufac…