NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Tuesday 29 March 2011

Almac has expanded its biopharmaceutical cold storage facilities in Craigavon, UK

outsourcing Pharma

Lonza invests in biomanufacturing

Lonza is to expand its biopharmaceutical manufacturing facility in Slough, UK. The company will invest £16m in a 6000m2M/sup> building including a fermentation suite, purification suites, process development laboratories and a GMP warehouse. The company expects the facility, which will allow it to respond to a broader range of customer projects, to be completed by the end of 2012.
The Engineer

Tuesday 22 March 2011

Angel leases facility

Angel Biotechnology has leased a biomanufacturing facility in Cramlington, UK. The facility, which used to belong to Angel before it withdrew from the site in 2007, will expand Angel's manufacturing capacity five-fold. The company has leased the facility for 15 years and expects to be operational before the end of this year.
Sharecast

Monday 21 March 2011

Lonza will provide cell line and process development for Athera Biotechnologies' monoclonal antibody PC-mAb

Karolinska Development

Contract manufacturer issues delay Regenrx clinical trial

Washington Business Journal

FDA and EMA start QbD pilot

The US FDA and the European Medicines Agency (EMA) will launch a three-year pilot program on 1 April to evaluate relevant quality data for new medicines. The Quality by Design (QbD) of pharmaceuticals involves an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality.
Pharma Times

Thursday 17 March 2011

Boehringer Ingelheim will provide process development and manufacturing of additional clinical material for MorphoSys's proprietary MOR208 antibody

Morphosys

Lonza will provide process validation and commercial manufacturing Enobia’s bone-targeted enzyme replacement therapy ENB-0040

GEN

Siegfried sales grow in 2010

Siegfried reported sales growing 11% to CHF314.4m in 2010. The company said its API sales grew by 14.1% to CHF252.2m while sales of formulated drug products remained constant.
Chem Manager

Amgen is to buy Pfizer's Dun Loaghaire, Ireland, manufacturing plant and will manufacture products for Pfizer

RTE

Socma and EFCG call for FDA inspections

Socma’s Bulk Pharmaceutical Task Force (BPTF) and European Chemical Industry Council’s Fine Chemicals Group (EFCG) are calling on the FDA to mandate inspections of non-US API manufacturing sites. The two organisations said the FDA should collect a fee for the cost of inspection and the maintenance of a database of inspected sites.
Socma

Tuesday 8 March 2011

CIA and UKTI seek exhibitors for Chemspec Europe

The UK Chemical Industries Association and UK Trade & Investment are seeking companies for the UK pavillion at Chemspec Europe in June. Grants are available to potential exhibitors.
Contact Neil Harvey for more details

Monday 7 March 2011

Evonik has acquired Boehringer Ingelheim Pharma's Resomer polymer technology for use in medical and pharmaceutical formulations

Chemistry Views

Brian Scanlan will succeed Michael Major as president and chief executive of Cambridge Major Laboratories

Milwaukee-Wisconsin Journal Sentinel

Helsinn to build cytotoxic plant

Helsinn Advanced Synthesis is to build a cytotoxic plant in Biasca, Switzerland. The CHF20m plant will have two production areas. One will have three reactor units capable of producing 10kg batches an the other will have larger reactor units to produce 20kg batches. Helsinn expects to begin commissioning projects for the plat in Q1 2012.
Cleanroom Technology