Robinson Pharma (R.P.I.) has been granted a Drug Manufacturing license by the State of California Food and Drug Branch of the Department of Health Services.
R.P.I met the requirements for facilities, personnel, training, and standard operating procedure for licensing as a Drug Establishment and demonstrated competence in manufacturing over-the-counter drug products, which validates compliance to current good manufacturing practice (CGMP).
The license places R.P.I., which specialises in soft gelatine encapsulation, in the top tier of contract manufacturers.
R.P.I. founder and chef executive Tuong Nguyen said: "The drug license is an important step in making Robinson Pharma Inc.
the leading contract manufacturing company in America.
Our vision is being realised and our success is the result of the hard work and commitment of our staff, and the valued support of our customers.
We recognise that quality is critical to our growth and we are setting increasingly more rigorous standards."
Meanwhile, Vybion , an early stage developer of recombinant proteins for biopharmaceuticals and diagnostics, has been awarded a contract by P2D in Cincinnati as part of a collaboration on a SBIR Phase II grant.
Vybion is developing a humanised version of the monoclonal antibody genes for an antibody that is specific for cocaine, whereby cocaine, bound to the antibody, remains in the blood before detoxification in the liver.
Prosensa and SynCo Bio Partners will be collaborating in the formulation and fill of RNA based therapeutics for the treatment of Duchenne Muscular Dystrophy (DMD).
Under the terms of the agreement, SynCo, the leading biopharmaceuticals manufacturer, will work with Prosensa, a clinical stage pharmaceutical company, to formulate the product for use in human clinical trials.
"SynCo is pleased to be working with Prosensa on this important clinical programme for the life saving treatment of DMD," SynCo chief executive Pierre Warffemius said.
"We aim to establish a long-term relationship with Prosensa to support their expanding portfolio of nucleic acid based therapeutics against neuromuscular disorders, by providing high quality aseptic formulation and filling services," he said.
In other contract manufacturing news, Diosynth Biotechnology has signed an agreement with VGX Pharmaceuticals for process development activities and cGMP production of clinical trial material for VGX Pharmaceutical's therapeutic drug candidate.
The drug VGX-100, a recombinant viral protein r (Vpr) can induce apoptosis - programmed cell death - in tumour tissues of the breast, prostate and brain.
Initial clinical trials will target patients with Non-Hodgkin's Lymphoma and gastric cancer.
Also in the area of cell-killing agents for cancer therapies, biotechnology company ImmunoGen of Cambridge has signed a nearly $7m (€5,176,481) manufacturing contract with pharmaceuticals maker Sicor Italy .
The agreement will be completed in early 2008.
Finally, Novogen announced it will use a red clover extraction facility in Switzerland to source its worldwide requirements for isoflavones to be used in the consumer products Promensil and Trinovin.
The move comes when there is no longer a need for the Australian-based company to have in-house isoflavone extraction facilities in order to protect its intellectual property in this area.
The move also frees up cash resources for the company and reduces working capital through a more sufficient supply chain.
The existing Novogen owned and operated Wyong isoflavone extraction facility, which opened 10 years ago, will be decommissioned and the property sold.