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news.Avid Bioservices (Avid), a provider of cGMP manufacturing services for the biotechnology and biopharmaceutical industries, has reported data related to the comparability of production run performance between its single-use bioreactors (Thermo Scientific HyClone SUB) and traditional stainless steel bioreactors at the Thermo Scientific BioProduction Optimization Workshop in San Francisco, California.
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The presentation included cell culture performance data comparing multiple stainless steel and SUB production runs at the 1000-liter scale in the company’s cGMP manufacturing facility in Tustin, California.
Avid claimed that Thermo Scientific HyClone SUB consists of a reusable stainless steel outer support container and SUB BioProcess Container (BPC) that integrates with existing bioreactor control systems, providing the benefits of single-use bioprocessing, eliminating the need to install a complete new bioreactor system. The retrofit product replaces the stainless steel bioreactor vessel in existing bioreactor systems, making it a flexible, rapid and economic option to increase bioreactor capacity.
Richard Richieri, senior vice president of technical operations for Avid, said: “Our HyClone SUB system provides important consistency, scalability and efficiencies in our cGMP biomanufacturing services.
“Data from both the 1000 and 100 liter SUB show our process is consistent and scalable, allowing us considerable flexibility to manufacture products using either the SUB or traditional stainless steel bioreactor systems to meet our clients’ clinical trial materials requirements.
“The manufacturing efficiencies from using our SUB, including reduced changeover time between manufacturing runs and shortened project timelines, are critical as we support our clients’ clinical and commercial production needs.”
Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals. The company, in addition to cGMP commercial product, also manufactures clinical supplies for all phases of clinical trials. The company’s range of cGMP services includes cell banking, stability testing, clinical and commercial product manufacturing and purification, bulk packaging, final product filling and regulatory support.
Avid also provides various process development activities, including cell line optimization, analytical method development and product characterization. The company also manufactures antibody, producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes.