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

Monday, 9 May 2011

Six inspections at Hovione plants

Hovione facilities have undergone six successful GMP inspections in the last eight months. Sites in China and Portugal have been inspected by the Japanese PMDA; the Portuguese authorities inspected a site in April and the US FDA inspected the Loures site twice and New Jersey once.
PR Newswire

DSM and Roquette are to build a 10,000 tonne/year plant for the production of bio-based succinic acid in Cassano Spinola, Italy

DSM

Sales for Wacker Biosolutions in Q1 grew 10% to €37.7m with strong demand for products used in pharmaceutical and agrochemical applications

Wacker

Q1 sales rise at Cambrex

Q1 2011 sales at Cambrex rose 9.8% to $61.7m compared to 2010. The company said the increase was due to higher sales of an API to a customer who resolved their supply chain disruption, higher volumes of generic APIs and increased volumes for a recently approved product.
Cambrex

Wednesday, 4 May 2011

Aptuit will provide manufacturing scale-up services for Iroko Pharmaceuticals' novel pain medications for Phase III clinical trials

Iroko Pharmaceuticals

Q1 contract revenues grow for AMRI

AMRI saw revenue growth in Q1 2011 driven by its contract manufacturing business. AMRI's development and small scale manufacturing revenue grew 24% to $10.5m and large scale manufacturing revenue grew 22% to $21.8m. The company has recently resumed GMP production at its Burlington, MA, facility and is working with the FDA to close out the Warning Letter as soon as possible.
AMRI

SAFC will manufacture the API for Pro-Pharmaceuticals' lead product candidate for anticipated use in clinical trials and sales in Colombia

Pro-Pharmaceuticals

Tuesday, 3 May 2011

Cambridge Major Laboratories has appointed Rick Proehl as Vice President of Manufacturing

Socma

CMC Biologics has appointed Claes Glassell as CEO

CMC Biologics

Carbogen-Amcis HPAPI facility meets standard

Carbogen-Amcis' new high potency API facility in Ahmedabad, India, has completed a containment performance evaluation. The facility, which is located on the Dishman Pharmaceuticals and Chemicals site, meets category IV standards.
Carbogen-Amcis

Thursday, 28 April 2011

Sales fell 14% at DSM's pharma business reflecting a drop in volumes in DSM Pharmaceutical Products

DSM

Record sales for SAFC

Sales for Sigma-Aldrich's SAFC division grew by 16% to $180m in Q1 2011 compared to 2010. Kirk Richter, Sigma-Aldrich's Interim Chief Financial Officer, Vice President and Treasurer, said this growth at SAFC was partially due to continued strong demand by biopharma customers as sales of biological drugs continue to expand and also to strong demand for materials and precursors for semi-conductor and LED applications. Rakesh Sachdev, Chief Executive Officer, President and Director, said SAFC has a record level of booked orders for future delivery.
Seeking Alpha

Thursday, 21 April 2011

TG United will provide commercial-scale manufacturing for Adeona Pharmaceutical's reaZin

Adeona Pharma

Hebei Aoxing API Pharmaceutical Company has adopted advanced process technology from Macfarlan Smith to manufacture naloxone hydrochloride API

In-pharma Technologist

Strong Q1 for Albemarle

Net sales for Albemarle's fine chemicals business rose 30% to $177.3m in Q1 2011 and income rose 151% to $29.5m. The company said the improvement was due primarily to higher volumes and favourable pricing.
Business Week

Monday, 18 April 2011

Bakhu to acquire Phoenix site

Bakhu Pharma has acquired the IP assets of Phoenix Chemicals and is negotiating to purchase the Annan, Scotland, site from the administrators, RSM Tenon. The acquisition is expected to be completed in the next few weeks. Bakhu Pharma was incorporated on 31 March.
BBC

Wednesday, 13 April 2011

Lonza reported a good Q1 2010 but warned that the strong Swiss franc and high raw material prices would dent its H1 performance

Lonza

Dr Reddy's opens Chirotech expansion

Dr Reddy's has inaugurated the new headquarters for its Cambridge, UK, subsidiary Chirotech and plans to invest further in the site. Chirotech provides development services in the areas of chiral technologies, particularly chemocatalysis and biocatalysis.
Financial Times

Monday, 4 April 2011

Kevin Cook has been appointed as Managing Director of Aesica's API business unit

Aesica

Following completion of the acquisition, Fujifilm has renamed the Merck Biomanufacturing Network as Fujifilm Diosynth Biotechnologies

Contract Pharma

BASF increases prices

BASF is increasing the prices of its pharmaceutical excipients and APIs by at least 10% depending on the product group. The company said it is raising prices as a result of a rise in costs for raw materials, energy and labour.
BASF

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

Monday, 28 February 2011

Fujifilm acquires Merck Biomanufacturing Network

Fujifilm has acquired Merck's Biomanufacturing network for $490m. The network consists of the former Avecia facility in Billingham, UK, and Diosynth RTP in Research Triangle Park, NC. Merck has committed to certain continued development and manufacturing activities with Fujifilm.
Bloomberg

Angel Biotechnology made its first pre-tax profit of £0.19m on revenues of £2.95m during 2010

Proactive Investors

Samsung to establish biomanufacturing jv with Quintiles

Samsung and Qunitiles have established a joint venture to provide biopharmaceutical contract manufacturing services in South Korea. Samsung will own 90% of the joint venture company and Quintiles 10%. The jv company will construct its biopharmaceutical manufacturing plant in the Incheon Free Economic Zone in South Korea and be equipped with cutting-edge technologies and 30,000L of mammalian cell culture bioreactor capacity. Groundbreaking is expected in the first half of 2011 and full-scale operation is expected to commence in April 2013.
Bloomberg Business Week

David Anton has been promoted to chief technology officer and senior vice president, process development and manufacturing at Codexis

Silicon Valley / San Jose Business Journal

Wednesday, 23 February 2011

Carbogen Amcis to restructure

Carbogen Amcis plans to restructure its three sites in Sqitzerland. Following the restructuring, the Aarau site will focus more strongly on development; the Hunzenschwil site on the pilot production of early phase projects and the Bubendorf site on large-volume production and the manufacturing of highly active agents. The company said that 60 of its 350 staff will be made redundant.
Carbogen Amcis

Viropro has acquired Alpha Biologics for $21m

Business Weekly

An affiliate of Sun European Partners has acquired NextPharma Technologies

PharmaBiz

Monday, 21 February 2011

Alphora to invest $4m

Alphora is investing $4m during 2011 expanding its facilities and capabilities for API technology development. The company said the expansion is to meet growing demand from customers. The company, which recently increased its R&D capacity by 50% by securing new research facilities, is adding isolation technology for its high potency API development services and will add a fourth cGMP kilo lab.
Contract Pharma

Thursday, 17 February 2011

Pfenex links with Boehringer Ingelheim

Pfenex will use its Pfenex Expression Technology to engineer production strains and processes for Boehringer Ingelheim's proprietary molecules, and molecules from Boehringer Ingelheim's contract manufacturing customers. The companies said the partnership will enable preclinical and clinical development to progress much more quickly and efficiently.
San Diego Union-Tribune

Angel Biotechnology will establish a new manufacturing facility in Newcastle, UK

The Herald

SAFC has completed the first projects at its large scale High Potency facility in Verona, WI

SAFC

Wednesday, 16 February 2011

Endeavour Speciality Chemicals has added compounds for oncology research and novel thioamides to its building blocks and reactive intermediates range

ImPress PR

Robinson Brothers has invested £300,000 in a calorimetry lab for scale-up process safety

Pharma

Profits fall at Dishman

Dishman Pharmaceuticals reported a its net profits fell 94% during its Q3 ended 31 December 2010, while turnover increased 4% to $51m. The company said performance was affected by a lower-than-expected performance at its Carbogen Amcis subsidiary.
Business Standard

FDA to outsource foreign plant inspections

The US FDA is looking to increase the number of overseas plant inspections through the use of third-party inspectors, according to John Taylor, the agency’s acting principal deputy commissioner. The agency is looking to reduce the average of nine yeas between plant inspections overseas.
Bloomberg

Angel Biotechnology has signed a five year pricing agreement with Materia Medica with a potential value of over £4.5m

Angel Bio

Q4 2010 sales at Cambrex rose 8% to $63.5m as a result of order timing and higher API sales

In-pharma Technologist

Monday, 14 February 2011

Merck's BioManufacturing Network will manufacture large scale GMP clinical supplies of Nuron Biotech's NU100 recombinant human interferon beta

Merck

Record quarter for SAFC

Sigma-Aldrich's SAFC business unit reported recede sales of $171m in Q4 2010. Sales for the unit in the full year 2010 were $647m up 9% on 2009. Rakesh Sachdev, Sigma-Aldrich cep, president and director said the company is "pleased with the higher level of SAFC's booked orders for future delivery as that is an indicator of future growth for that business". He added that "we expect our SAFC Pharmaceutical business to improve further in 2011" as a result of new added capacity in Wisconsin and California. Additionally, Sachdev said that despite the challenges facing the SAFC Custom Pharma business in Europe the SAFC Custom Pharma business in the US and the international markets is doing quite well.
Seeking Alpha

Novasep has partnered with instrAction to develop and operate or supply optimised large-scale chromatography processes to purify taxane-based APIs

In-pharma Technologist

DSM Biologics has achieved 11.5g/L tiers using its XD process technology with a CHO cell line producing an Fc-fusion protein

DSM

Wednesday, 9 February 2011

Boehringer to manufacture Elan antibodies

Boehringer Ingelheim will provide technical development, clinical manufacturing and all related regulatory filing support services for antibodies discovered by Elan.
RTE

The assets of Phoenix Chemicals in Arran and the Wirral, UK, are for sale by the administrators

Winter Hill

DSM Biologics will provide process development and cGMP manufacturing for NKT Therapeutics lead product iNKT mAb

DSM

Tuesday, 8 February 2011

Ampac adds new facility

Ampac Fine Chemicals has added a second semi-works facility in Rancho Cordova, CA. The company said the facility was part of several capital improvements in progress during 2011 and became fully operational in January. This facility offers a state of the art, remotely operable facility that is designed to safely run hydrogenations, hazardous chemistry and potent compound processes.
Ampac

Dalton Pharma will provide cGMP API manufacturing and fill/finish services for Oncovir’s collaboration with the Cancer Vaccine Acceleration Fund

Dalton

ScinoPharm will provide commercial manufacturing for Clinical Data's vilazodone hydrochloride API

ScinoPharm

KaloBios Pharmaceuticals will use BioWa and Lonza's Potelligent CHOK1SV cell line for the development and production of its Humaneered antibodies

Genetic Engineering News

Almac has opened analytical labs at its new headquarters in Pennsylvania

Outsourcing Pharma

Monday, 7 February 2011

Former Biogen Idec President and CEO, James Mullen, has been appointed as CEO of Patheon

Research Triangle News

Large scale manufacturing underpins AMRI revenues

Contract revenues rose 4% at AMRI to $163.2m in 2010. Of this revenues for development/small scale manufacturing fell 4% to $36.5m and revenues for large scale manufacturing grew 13% to $71.0m.
Albany Business Review

Pharma products boost Codexis revenues

Codexis' revenues grew 29% to $107.1m in 2010. The growth was driven by a 77% increase in sales of pharmaceutical products, from $18.6m to $32.8m, and increases in collaborative R&D and government grants. The company reported a net loss of $8.5m a reduction on the loss of $20.3m in 2009. Codexis forecasts revenues of over $120m in 2011.
Codexis

Nitto Denko has acquired Avecia Biotechnology, the DNA- and RNA-based therapeutics manufacturer

Mass High Tech

AMRI's Burlington, MA, facility has received approval from the Italian Medicines Agency for the manufacture of octreotide for a customer in the EU

RTT

ICIG to buy Genzyme API unit

International Chemical Investors Group is to acquire Genzyme's API manufacturing unit. ICIG will maintain operations at Genzyme's Liestal, Switzerland, facility and rename the unit Corden Pharma Switzerland LLC. As part of the agreement, ICIG will enter into a five-year supply contract to provide Genzyme with materials needed for the production of eliglustat tartrate, an investigational treatment for Gaucher disease Type 1 that is currently in phase 3 clinical trials. Additionally, ICIG will supply materials needed for the manufacture of other treatments in earlier stages of development. Financial terms for the agreement, expected to close during Q1, were not disclosed.
Boston Globe

RecipharmCobra Biologics has been granted European patents on its Xer-cise genetic engineering technology

Recipharm

Carbogen Amcis has installed new stability study capabilities at its Hunzenschwil, Switzerland-site to meet ICH guidelines

Contract Pharma

Wednesday, 2 February 2011

Informex returns to New Orleans, 14-17 February 2012

Informex

Fine chems grow for Johnson Matthey in Q3

Q3 sales at Johnson Matthey's Fine Chemicals Division improved 10% over last year. The company said sales of APIs remained good, particularly in North America, and the performance of its Pharmaceutical Services business continued to improve.
Johnson Matthey

Laureate Pharma has changed its name to Laureate Biopharmaceutical Services

Laureate Biopharma

Monday, 31 January 2011

Recipharm sells Oxford facility

Recipharm has sold its decommissioned manufacturing facility in Oxford, UK, to Oxford BioMedica for £1.9m. Recipharm acquired the facility when it bought Cobra Biologics in 2010. Oxford BioMedica will recommission the plant over the next 12 months to provide production capacity for its proprietary LentiVector gene delivery technology.
Recipharm

Lonza is to repurchase one million shares during the next year

Lonza

Phoenix Chemicals has made 36 people redundant at its Wirral, UK, site and 7 redundant at its Annan site

Wirral News
Dumfries and Galloway Standard

New contract as Angel raises cash

Angel Biotechnology will provide pre-GMP services for Pathfinder Cell Therapy's novel cell therapy. Additionally, the company has raised £1.9m in a placing of 553,435,720 ordinary shares.
Angel Biotechnology
Angel Biotechnology

Pfenex will develop a scalable production process for a key Malaria antigen in a $3.1m subcontract from SAIC

Xconomy

Wednesday, 26 January 2011

Lonza robust in 2010

Lonza reported sales in its custom manufacturing business unit increase almost 2% to CHF1.4bn in 2010. The company said this growth was driven primarily by improved capacity utilisation in large-scale biological manufacturing as a result of new product introductions, especially in the second half of the year. The company has almost 300 products in its chemical pipeline and about 260 in its biological pipeline and reported capacity utilisation rates of around 75% for both businesses. Lonza also said that the build-out of its large scale mammalian biopharmaceutical facility in Singapore is on track, with start-up targeted in Q3 2011. Additionally, TL Biopharmaceuticals, its joint venture with Teva, has commenced a clinical phase-I trials with its first biosimilar product.
Looking forward, Lonza expects to continue to benefit from increased outsourcing of manufacturing and development by pharmaceutical and biotechnology companies, which combined with stronger product pipelines, improved capacity utilisation and a more appropriate cost base, provides the company with a good platform for a solid performance in 2011.
Reuters