PPHM Pharma - Unternehmen mit Top-Meldung

December 10, 2014
Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity
State-of-the-Art Facility Design Using Modular Clean Rooms and Fully-Disposable Technologies Provide Flexibility to Meet Growing Production Demands; Facility Expected to Be Ready for cGMP Production in Mid-2015
TUSTIN, CA -- (Marketwired) -- 12/10/14 -- Avid Bioservices, Inc, the contract manufacturing subsidiary of Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), today announced it has initiated an expansion of its biomanufacturing capacity. Avid provides high quality clinical and commercial manufacturing services under cGMP for the biotechnology and biopharmaceutical industries. The new production facility will more than double Avid Bioservices' current manufacturing capacity in a state-of-the-art facility design.
This facility will employ an innovative and flexible modular clean room design and the latest in single-use technologies that provide expanded capacity to meet the growing needs of Avid's existing and future clients. The capacity expansion will take place within an existing 40,000 square foot warehouse located adjacent to the company's current campus. The new cGMP facility will accommodate multiple single use bioreactors of up to 2,000 liters, downstream processing suites, and dedicated support utilities that will allow for the production of a variety of biological products.
"This new production suite will be a key component of our strategic growth as it allows us to meet the increasing demand for our clinical and commercial manufacturing," said Steven King, president at Avid. "As one of the early adopters of single-use technology, this expansion allows us to build upon our expertise in what is now a common mainstream practice for biologics production and is in line with our commitment to providing our clients with the highest quality service offerings to meet every phase of development and production."
"This will truly be a cutting edge facility utilizing a leading trend in biomanufacturing in terms of flexibility and efficiency," said Robert Garnick, Ph.D. head of regulatory affairs at Peregrine. "We have been pleased that the design, the flow, as well as equipment and timelines, have all been well received by leaders and experts in biomanufacturing. We look forward to having this facility build upon our exemplary inspection and audit record that Avid has achieved from multiple regulatory agencies."