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

Thursday 25 October 2012

Althea Technologies will manufacture circumsporozoite protein for Pfenex using Pfenex's production process


Pfenex

DSM Pharmaceutical Products will provide process development and cGMP manufacture of Paranta Biosciences' lead recombinant human protein at its Brisbane, Australia, facility


Fierce Pharma Manufacturing

Fujifilm Diosynth Biotechnologies and Piramal Healthcare UK will jointly offer seamless contract development and manufacture of antibody drug conjugates


Manufacturing Chemist

The US FDA has approved 28 NMEs to date in 2012


FDA

John Birch has been appointed as a non-executive director at Cobra Biologics


Outsourcing Pharma

Lonza will develop and manufacture OncoMed’s pipeline of anti-cancer stem cell therapeutics at its mammalian manufacturing facility in Slough, UK


GEN

Sigma Aldrich reported a 17% rise in revenues at SAFC to $211m in Q3 driven by a double-digit growth in the custom pharma manufacturing business


Nasdaq

EU confirms API import rules

The European Union (EU) has confirmed its new rules regarding the import of APIs into member states. From 2 Jan 2013 all imported APIs must have been manufactured to an EU-equivalent GMP and by 2 July 2013 the importer will need to request and receive written confirmation of this compliance from the relevant regulatory authority.
Pharma Times

AMRI has extended its supply contract with Shire for a further five years


Pharmaceutical Business Review

Boehringer Ingelheim has resumed manufacturing at its Ben Venue, Ohio, facility


Nasdaq

Sales for Albemarle's fine chemistry business in Q3 2012 were $193.0m up 8% over 2011


Seeking Alpha

Tuesday 16 October 2012

Dottikon to expand

Dottikon plans to increase its process development and optimisation capacities by 20% and extend its high-pressure technology in heterogeneous and homogeneous catalysis. The company expects the new capacity to be available in H2 2013. Additionally the company will strengthen and expand its catalysis group, including the development and acquisition of high-pressure parallel screening equipment. The company has terminated its talks with Solvias.
Speciality Chemicals

Ark Therapeutics will manufacture Laurantis Pharma's Lymfactin


Ark Therapeutics

Pharma looks back to the west

Speaking at CPhI Albemarle’s director of fine chemistry services David DeCuir said that the pharma industry is looking back to western suppliers as a result of quality issues, potential interruptions with supplies from Asia and rising costs.
In-pharma Technologist

Recipharm will provide formulations envelopment for Astimex Pharma at its Solna, Sweden, site


Pharmaceutical Business Review

Wednesday 10 October 2012

Piramal Healthcare is looking to expand its CRAMS business via acquisitions in the US or Europe


Outsourcing Pharma

Novasep to build commercial scale chromatography plant

Novasep is investing €30m to build a commercial API chromatography plant in Mourenx, France, to address its projected demand for a large volume, highly purified APIs. The company said it expects the facility to be operational within 18 months.
GEN

Lonza will produce induced pluripotent stem cells for the National Institutes of Health Center for Regenerative Medicine in Walkersville, MD


Lonza

BASF will launch a production line for precious metal-based fine chemical catalysts in Mangalore, India


BASF

Dr Reddy's Laboratories has expanded activated mPEG manufacturing and the development and manufacture of APIs at its manufacturing facility in Mirfield, UK


Pharmabiz

Olympus Biotech will provide contract biomanufacturing from its state-of-the-art facility in Lebanon, NH


Outsourcing Pharma

Almac readies API manufacturing expansion

Almac has almost completed the expansion of its API manufacturing facility in Craigavon, UK. The upgraded facility, which will be operational by the end of the year, includes the installation of two 1000L reactors and state-of-the-art pressure filter dryer.
Almac

Almac and DSM to collaborate in biocatalysis

Almac and DSM Pharmaceutical Products will partner their biocatalysis capabilities for the manufacturing of APIs. Almac said its expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-ton scale.
Pharmaceutical Business Review

Sunday 7 October 2012

Dalton Pharma Services will provide scale up and manufacture of a conjugate vaccine for tuberculosis developed by the University of Guelph


Research Views

Novasep has appointed Roger-Marc Nicoud as non-executive chairman of the board and Patrick Glaser as president and CEO


Novasep

AMPAC Fine Chemicals has applied to the US Drug Enforcement Administration to be registered as a bulk manufacturer of Tapentadol


Federal Register

Lonza-Teva biosimilar on hold

Teva has suspended its phase III study of a biosimilar of Rituxan, which it os jointly developing with Lonza. Lonza's shares fell as the company said the partners are evaluating how to move forward with testing as the regulatory environment for biosimilars gets more restrictive.
Fierce Biotech and Business Week

Lonza will manufacture of Celladon’s phase IIb-stage targeted enzyme replacement therapy candidate Mydicar for clinical trials


GEN

BASF relocates pharma ingredients to New Jersey

BASF will centralise the management of its Pharma Ingredients and Services business unit in Florham Park, NJ. The unit, which was previously managed from Evionnaz, Switzerland, will be led by Scott Thomson as Senior Vice President. BASF said the relocation of management will not affect the regional business and production units in Europe, including Evionnaz.
New Jersey Star Ledger

SAFC expands in Irvine

SAFC will add a powder manufacturing line at its Irvine, Scotland, facility. The expansion will be supported with a £1.5m grant from Scottish Enterprise and will create 24 new jobs.
St Louis Business Journal