Cambridge Major Laboratories has just announced a major expansion into large scale active pharmaceutical ingredient (API) manufacturing, revealing that on 5 June the company will be breaking ground on a new 120,000 square foot manufacturing site next to its headquarters in Germantown, Wisconsin, USA.
The firm said that the move is is in response to its "large and growing pipeline of late developmental and commercial APIs", as the existing facility, that it opened in 2004, is currently approaching the maximum of its operating capacity in this regard.
The facility is designed with multiple GMP manufacturing suites capable of producing multi-ton quantities of API, and is scheduled for completion in August next year.
Initially the plant will house six manufacturing suites with reactors up to the 2000 gallon scale with complete isolation and containment, the firm said, adding that it will also house a number of vessels for hydrogenation and cryogenic reactions to achieve "maximum flexibility and utility" at the site.
As as when required, additional manufacturing suites up to the 4000 gallon scale will be built further down the line.
VGX Pharmaceuticals (VGX) has signed a multi-year supply agreement to provide plasmid DNA for toxicology and clinical trials of the United Kingdom Cystic Fibrosis Gene Therapy Consortium.
The consortium comprises of over 80 scientists in Edinburgh, London and Oxford, all of whom are looking to discover new gene therapies for the lungs of patients with Cystic Fibrosis.
Under the supply agreement, VGX will provide multiple batches of a CFTR product until 2010. The firm said that if all options are exercised, several hundred grams of plasmid DNA will be provided, "making this agreement one of the largest contracts for non-viral gene therapy products ever undertaken".
Consortium lead investigator Dr Deborah Gill said: "Our CpG-free product, utilising technology developed by Cayla-InvivoGen, presented some unique challenges for large-scale production, but the team at VGX used their vast expertise in producing non-viral products to meet our demanding timelines.
"Preliminary results suggest that the materials produced at VGX are of a higher purity than previous batches leading to better overall performance in preclinical studies."
Meanwhile, formulation services firm Xcelience has announced its expanded offering of X-ray Diffraction (XRD) capabilities to support clients' needs in the areas of preformulation and formulation development, following the purchase of an XRD instrument.
Mark Cappucci, team leader for Preformulation and Formulation said the firm did so "at the urging of several of our clients", in order to enhance its overall capabilities in formulation analysis, polymorph identification, salt screen and selection, and crystallinity determination.
This information can be provided to aid early development activities with use of a small amount of sample which is nondestructive to the sample being evaluated, he added.
"The XRD is the key technique for solid state drug analysis benefiting all stages of drug development, testing, production and stability, "said Derek Hennecke, company president and CEO.
"This new capability will help our clients make faster and smarter decisions on their new chemical entities (NCEs) and further enhance our scientific offerings to the science of drug development."
Only recently Xcelience became the first contract manufacturer in North America to purchase the Xcelodose 600 S precision powder micro-doser and automated encapsulator, made by Capsugel.
According to company, the S model fills at speeds of over 600 capsules an hour at 50 per cent greater throughput than its predecessor, the Xcelodose 600.
In other news, Dr Reddy's Laboratories has confirmed the completion of two previously-announced acquisitions: Dowpharma's small molecules business, along with its facilities in Mirfield and Cambridge, UK; and BASF's pharmaceutical contract manufacturing business and related site in Louisiana, USA.
No additional terms or conditions of the transactions were revealed.
