Laureate Pharma has entered into a cGMP contract manufacturing agreement with Tolera Therapeutics, a biotechnology company that develops targeted therapies and safer solutions for immune modulation and related medical needs. Under the agreement, Laureate will produce Tolera's TOL101 monoclonal antibody under cGMP conditions to be used in clinical trials. Terms of the agreement were not disclosed.
   
"We are pleased to work closely with Tolera to accelerate their antibody therapeutics program to clinic," said Robert J. Broeze, Ph. D., president and chief executive officer of Laureate. "We are committed to providing Tolera with superior services to help them achieve their manufacturing objectives."
   
"We are excited to work with Laureate, a company with demonstrated expertise in biopharmaceutical manufacturing. Their capabilities in both clinical and commercial-grade materials can support our aggressive development and commercial plans," said John J. Puisis, president and chief executive officer of Tolera. "We look forward to our partnership with Laureate in utilizing their specialized experience in the manufacture of monoclonal antibodies."

QSV Biologics Ltd. has formed an Australian subsidiary, QSV Biologics Australia Pty Ltd., and has appointed Dr. Neville McCarthy to its board of directors.
    
Dr. Graeme Macaloney, founder and chief executive officer, said, “The formation of our Australian subsidiary demonstrates the commitment QSV has for the biopharmaceutical industry in Australasia. The addition of Dr. McCarthy, a founding statesman of the Australian biotech industry, including 17 years at the helm of CSL, brings tremendous experience of — and connectivity to — the Australian and regional industry. I am very pleased and excited to be working with such a gentleman and scholar.”
   
Dr. McCarthy is a medical scientist and an officer of the Order of Australia. His career encompasses the founding and operation of his own medical practice, serving as director with ER Squibb, managing director of Commonwealth Serum Laboratories (CSL), managing director and chairman of Chiron Mimotopes (Australia), chairman of Mabtech Ltd, chairman of Monash IVF Group, and director of Southern Medical Diagnostics Pty. Ltd.

Avid Bioservices, Inc. has signed a manufacturing supply agreement with Catalyst Biosciences to produce clinical-grade material for Catalyst's drug candidate, CB 813, a new version of factor VIIa for the treatment of acute bleeding in hemophilia patients.
   
Under the terms of the agreement, Avid will begin manufacturing drug supply under cGMP regulations and provide cell bank preparation, process development, and preparation of the manufacturing portion of the NDA.  Further details were not disclosed.
   
“This agreement with Catalyst Biosciences for their lead clinical candidate is the most recent example of the traction we are gaining as a trusted provider of cGMP manufacturing services, as well as our broad capabilities as a provider of valuable ancillary services," said Steven W. King, president of Avid.  "We are delighted to be working with the talented Catalyst team and their promising engineered protease technology.”
   
"Avid's expertise in the scale-up and manufacture of clinical-grade biotechnology therapeutics and their strong customer orientation made them a good choice for Catalyst,” said Nassim Usman, Ph.D., chief executive officer of Catalyst Biosciences.

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