Monday, 29 September 2008

CMC Biologics to expand capacity

CMC Biologics will expand capacity at its Bothell, WA, contract manufacturing facility five-fold as part of a $35m expansion plan. CMC expects the project to be completed by mid-2010.
Seattle Times

Bayer has teamed with Kentucky BioProcessing to advance the manufacture of drugs in tobacco plants

Loiusville Courier-Journal

DSM Biologics and Crucell have scaled up their high-titer fed-batch process for producing biologics using the PER.C6 system


Piramal launches clinical trial supplies and acquires CRO

Piramal Healthcare has launched a clinical trials supply service from its Morpeth, UK, facility. The company has also acquired a Romanian clinical trials management company, Tangent Data s.r.l., which will be integrated into its contract manufacturing business.
Piramal Healthcare

Excelsyn upgrades Holywell

Excelsyn has added Fauske adiabatic and TSU calorimetry equipment at its Holywell, Wales, site and is now able to conduct stability testing in-house. Excelsyn has also added laboratory-scale hydrogenation capability. These additions are part of the recently completed initial phase of its three-year expansion and upgrade programme at Holywell.

Novasep has added a cGMP pilot scale continuous chromatography unit at its Chasse sur Rhône, France, facility


Wednesday, 24 September 2008

Pfizer to use sonocrystallisation

Pfizer will use Prosonix's Prosonitron reactor and sonocrystallisation technology in its API production at its manufacturing facilities in Ireland. Prosonix claims the technology allows the control of many aspects of complex pharmaceutical crystallisation processes, including control of crystal size, shape, and purity, the selective production of polymorphs, enhancing both manufacturing productivity and ultimate formulation performance of drug product.
In-Pharma Technologist

Aesica has established a US subsidiary


Monday, 22 September 2008

Calyx Chemicals and Pharmaceuticals plans acquisition to broaden capabilities from API manufacturing to CRAMS

In-Pharma Technologist

RohnerChem to scale up EnCat

RohnerChem is to scale up Reaxa's EnCat technology. The companies have previously worked on initial screening and process development for the encapsulated catalysts.
In-Pharma Technologist

Clariant to sell businesses


Wednesday, 17 September 2008

Pharmatek opens high potency facility

Pharmatek has opened its 1800m2 highly-potent and cytotoxic facility in San Diego. The new development includes analytical and formulation development laboratories and cGMP manufacturing suites.

Ranbaxy products blocked by FDA after warning letters for two plants

In-Pharma Technologist

BASF offer rejected by large Ciba shareholder


Tuesday, 16 September 2008

DSM-LibraGen amine technology deal

DSM and LibraGen will co-develop new omega-transaminases for production of chiral amines. LibraGen will use its enzyme discovery and development to identify enzymes to convert ketones to optically pure amines. DSM will produce the enzyme using its fermentation capabilities and PluGbug expression platform.

KPMG predicts Indian contract manufacturing market to reach $2.46bn/year by 2010

Live Mint

Significant growth in Excelsyn sales

Excelsyn saw like-for-like sales increase 43.5% to $28m for its year ended 31 May. The company attributed the growth to an acceleration in volume demand and customer numbers for its pharma synthesis business and continuing growth in outsourcing of development and manufacturing services. Excelsyn ceo Ian Shott said the company's strategy, introduced in January, was delivering a significant upturn in business.

European Commission updates radiopharmaceutical GMP requirements

In-Pharma Technologist

BASF acquires Ciba for CHF6.1bn, further sector integration expected

Financial Times

Thursday, 11 September 2008

Lonza expects more outsourcing, plans acquisitions

Lonza CFO Toralf Haag has said the company expects to benefit from the pharma industry's continuing trend towards more outsourcing. He also said the company has CHF1.5bn-2bn ($1.3bn-$1.8bn) available for acquisitions in the next year.
The Guardian

Tuesday, 9 September 2008

FDA revises cGMP guidelines

The FDA has amended its cGMP requirements for finished pharmaceuticals. This amendments concern aseptic processing, verification of performance of
operations by a second individual, and the use of asbestos filters. The FDA said it changes were to "modernise or clarify some of the requirements as well as to harmonize them with other FDA regulations and international cGMP standards". The amendments which are the first phase of an incremental approach to modifying the cGMP regulations will be effective from 8 December 2008.

Bayer shares rose on market rumours of takeover interest from Pfizer


CVC Capital Partners has received approval from the EU for its acquisition of part of Evonik


Sunday, 7 September 2008

SOCMA plans for "Last 100 days"

SOCMA intends to ensure that legislation key for the success for its members does not fall by the wayside during the last 100 days of the Bush Administration. SOCMA will be meeting regulatory agencies overseeing unfinished business to urge completion of its priority issues as well as ensuring that the McCain and Obama campaigns are aware of these issues.

Human Genome Sciences will use excess manufacturing capacity to produce biosimilar products for Hospira


SAFC confirms HP-API expansion plans

Sigma-Aldrich has confirmed plans for a $30m expansion of its SAFC high potency API facility in Madison, Wisconsin. SAFC has purchased 15 acres of land in Verona, Wisconsin, for the 4500m2 facility, which will include development laboratories, a 150L mini-processing plant and two large-scale cGMP manufacturing suites with reactors up to 4000L. Construction is expected to be completed by end-2009.
In-Pharma Technologist

Dishman plans Carbogen Amcis IPO

both acquired by Solutia in 2000. Solutia rebranded the businesses as Solutia Pharmaceutical Services before formally merging them into a single legal entity: Carbogen Amcis in 2006. Dishman acquired Carbogen Amcis from Solutia in May 2006 and has made a number of investments in the business over the past two years.
Sify Business

Codexis withdraws IPO citing unfavourable market conditions

San Jose Business Journal