Therapure Biopharma Inc. Commissions Its Commercial-Scale Lyophilizer
Thomas Wellner, President and CEO of Therapure Biopharma Inc. recently announced that the Company has completing the commissioning and validation of its commercial-scale pharmaceutical-grade freeze dryer and now offers commercial scale freeze drying (lyophilization) for contract manufacturing of biopharmaceuticals.
Lyophilization is used to convert biopharmaceuticals that are manufactured in an unstable liquid format into a stable, dry powder that can be reconstituted to a liquid format for administration to patients. Lyophilized forms of these life-saving products are more easily handled and stable than their liquid forms and therefore lyophilization is commonly used in the manufacture of these products.
“Until today, commercial-scale lyophilization has not been readily available in Canada,” said Mr. Wellner. “The launch of our commercial-scale lyophilizer, combined with our existing aseptic filling capabilities in vials and bags, significantly broadens the service offering we have for clients,” Mr. Wellner continued.
The new lyophilizer has been integrated into Therapure’s existing aseptic vial filling suite. This integrated suite now includes an automated vial filler, vial transporter, and the 75 square foot lyophilizer. All parts of this automated suite are contained within Class 100 clean space and are fully compliant with Health Canada and FDA GMP requirements The fill suite handles fill volumes ranging from 2ml to 200ml in glass vials with rubber stoppers and capped, and is capable of batch sizes ranging from 35,000 units per shift for smaller vials to 3,000 units per shift for larger vials.
About Therapure Biopharma
Therapure Biopharma Inc. is an integrated biopharmaceutical company that develops, manufactures, purifies, and packages therapeutic proteins. As a contract development and manufacturing organization (CDMO) Therapure Biopharma applies scientific, manufacturing, and downstream purification expertise with an intimate understanding of advanced biology, complex proteins, and regulatory processes to develop effective and innovative solutions to advance products from discovery to market.
For more information, visit: www.therapurebio.com
SOURCE: Therapure Biopharma Inc.