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

Thursday, 8 July 2010

Jubilant to focus on life sciences

Jubilant Organosys is to spin off its agri-chem and performance polymer business units into a separate business Jubilant Industries and rename itself Jubilant Life Sciences.
Reuters

Tuesday, 6 July 2010

Socma’s Bulk Pharmaceuticals Task Force (BPTF) has introduced a standardised quality drug agreement for CMOs and their customers

Socma

Girindus will validate a manufacturing process for an oligonucleotide product currently in Phase III clinical trials

Girindus

Aptuit acquires GlaxoSmithKline's medicines research centre in verona, Italy

PM Live

BASF merges Swiss fine chems units

BASF has merged its Evionnaz, Switzerland- based businesses BASF Orgamol Pharma Solutions and BASF Fine Chemicals Switzerland into a single organisation, BASF Pharma (Evionnaz). BASF said the merger reduces complexity at its site and simplifies processes.
In-Pharma Technologist

Thursday, 1 July 2010

Aesica acquires R5, plans more

Aesica has acquired R5, which develops and manufactures new medicines and clinical trial materials, for an undisclosed sum. Chief Executive, Robert Hardy, said the company is currently considering a number of additional takeover targets overseas as part of its expansion plans including a formulation manufacturer in the US and Europe.
North East Business

CPhI to be held in Frankfurt in 2011

The annual trade show will take place on 25-27 October 2011 at the Messe, Frankfurt.
PR Newswire

Synthetech has hired a financial adviser to explore alternatives including selling the company

Portland Business Journal

Saltigo's Leverkusen site has successfully completed an FDA audit

Contract Pharma

DCGI to inspect China plants

India's drug regulator, the Drug Controller General of India (DCGI), is planning to start inspecting manufacturers in China supplying intermediates and APIs to Indian manufacturers.
DWS Pillscribe

Rumour: Dishman to sign manufacturing deals worth $40m with Abbott and Merck

Economic Times

Wednesday, 23 June 2010

ICICI seeks buyer for RFCL

ICICI Ventures is looking to sell RFCL, which includes fine chemicals and in vitro diagnostics businesses. ICICI is believed to be looking to raise $87m.
Business Standard

Borregaard closes Italian plant

Borregaard Synthesis is closing its production plant in Ravenna, Italy, as a result of challenging market conditions which it does not see changing in the near future. 40 employees will be affected.
Borregaard

Tuesday, 22 June 2010

Ricerca gains DEA licence; ISO 9001 certification

Ricerca Biosciences has gained a US Drug Enforcement Agency (DEA) licence for its Concord, OH, facility which allows the company to produce controlled bulk APIs for phase I to II trials. Additionally, Ricerca's Lyon facility has obtained the ISO 9001:2008 certification. The company's Taipei facility received the ISO 9001:2008 certification in October 2009.
Outsourcing Pharma
Ricerca

AMRI to buy back $10m shares

Business Week

Monday, 21 June 2010

UKTI seeks companies for UK pavilion at CPhI

UK Trade & Investment is seeking UK-based companies offering UK-origin products and services within the fine and speciality chemical industry, as well as relevant service providers to the pharmaceutical industry for the UK pavilion at CPhI in October.
For more information contact UKTI

Siegfried has broken ground on its new 700m2, $1.5m warehouse in Pennsville, NJ

NJ.com

Kaneka has acquired biologics manufacturer, Eurogentec

Nikkei

Codexis and Merck receive Presidential award

Merck and Codexis have been awarded the Presidential Green Chemistry Challenge Award from the US Environmental Protection Agency for their development of a novel biocatalytic method for the synthesis of diabetes drug, sitagliptin. The award recognises new technologies that help prevent pollution by reducing or eliminating hazardous waste in industrial production. Additionally, the companies have published details of the process, which uses a customised enzyme to perform a key step in the synthesis, in the journal Science.
Codexis
Reuters

FDA plans new manufacturing rules

The US FDA is planning to new regulations to tighten up regulations for drugmakers that outsource manufacturing. The FDA said it may require drugmakers to conduct on-site audits of contract manufacturing facilities. Additionally, the agency is considering issuing warning letters to both the contact manufacturer and drugmaker if issues are found.
Wall Street Journal

Thursday, 17 June 2010

AMRI has acquired Hyaluron for $27m to add pre-filled syringe contract manufacturing capabilities

Reuters

Evonik has commissioned its precious-metal powder catalysts manufacturing plant in Shanghai

Evonik

Jubilant invests in Gujarat

Jubilant Organosys is building two 10,000-tonne/year units at its special economic zone at Bharuch in Gujarat. One plant will produce niacinamide and the other 3-cyanopyridine.
Business Standard

SAFC invests in Scotland and Missouri facilities

Sigma-Aldrich's SAFC division is expanding its network of global 'Centers of Excellence' designed specifically to support the seamless upstream and downstream production of liquid cell culture reagents at its St. Louis, Missouri site and its Irvine, Scotland facility. The work is expected to finish in Q4 2010.
SAFC

Rumour: Is Lilly looking to add custom manufacturing facilities in India?

DNA India

Synthetech reported a 37% decline in revenues in its Q4 ended 31 March to $4.2m and a decline of 23% to $15.2m for its fiscal 2010

Synthetech

Thursday, 10 June 2010

Lonza adds development services

Lonza has launched a new set of immunogenicity, stability and protein engineering services designed to improve the quality, safety, efficacy and manufacturability of antibodies, therapeutic proteins and vaccines. The Applied Protein Services platform complements the company's process development and manufacturing capabilities while advancing its efforts to incorporate Quality by Design (QbD) principles.
Lonza

Xcellerex building biomanufacturing facility

Xcellerex has started construction of its state-of-the-art cGMP biomanufacturing facility in Marlborough, MA. The facility will use Xcellerex's single use bioreactors and downstream unit operations to provide bridge biomanufacturing services for clients that are planning or building their own facilities using Xcellerex technology. The plant, which is due to be completed in September, will also support Xcellerex’s contract manufacturing operations.
Xcellerex

DSM BioSolutions will manufacture Novacta Biosystems' C. difficile antibiotic compound at its Capua, Italy, facility

Manufacturing Chemist

Tuesday, 8 June 2010

Cellectis bioresearch will use its meganuclease technology to deactivate the glutamine synthetase in Lonza’s proprietary CHO cell line

Cellectis

Albemare to build kilo-lab in Belgium

Albemarle fine chemistry services division is building a state of the art kilo lab in Louvain la Neuve, Belgium. The facility will contain the highest quality processes and safety features and have capabilities up to and including 50L glass lined vessels.
Albemarle

Ash Stevens to expand capacity

Ash Stevens will invest $20m to expand its API production capabilities in Riverview, MI, over the next five years. CEO Stephen Munk believes this will expand production by 50-80% and allow the company to hire another 50 workers. In the first phase Ash Stevens will add a 1000m3, $3.5m warehouse, which will be completed by October. The second phase of the project, which will start in 2011, will replace a 3400L reactor bay with a 8500L reactor bay with 1900L, 2800L-gallon and 3800L vessels.
Crain's Detroit

Lonza will manufacture and market California Stem Cell's pluripotent stem cell products

Nasdaq

Almac is planning to add 260 jobs at its new headquarters building near Philadelphia

Philadelphia Business Journal

Fine chems sales grow for Johnson Matthey

Sales at Johnson Matthey's Fine Chemicals Division rose 2% to £219m and operating profit rose 13% to £55.8m. The company expects to deliver steady growth in the divison, but said that H1 results this year would be impacted by the absence of the $12m one-off benefit in 2009/10 from the launch of the generic version of Adderall XR.
Johnson Matthey

Angel Biotechnology reported a reduced Q1 loss and expects to make its first profit in H1

The Herald

Ubichem research has received approval to supply radiolabelled APIs

Out-sourcing Pharma

Angel Biotechnology will provide GMP manufacturing to Materia Medica for antibodies, in a £1.3m contract

Angel Bio

Siegfried will supply at least 60% of Jazz Pharmaceuticals sodium oxybate requirements

Siegfried

Sales at Dottikon fell 25% to CHF113.1m in the year to 31 March

Dottikon

Thursday, 27 May 2010

Alpha Biologics is adding R&D and process development labs in Cambridge, UK

Business Weekly

Codexis saw revenues grow 32% to $25.7m in Q1 2010 compared to 2009 and its losses for the quarter narrow to $1.4m from $6.1m last year

San Francisco Business Times

Jubilant Organosys has repaid $50m foreign currency convertible bonds

MyIris

AMRI cuts back in US

AMRI is closing its Rensselaer, NY, facility, with the loss of 50 jobs. A further 30 jobs will be lost at its other US facilities while the company plans to add 180 jobs in Asia as it invests $30m in its international facilities.
Albany Business Journal

Tuesday, 25 May 2010

Biocon will manufacture Optimer Pharmaceuticals' fidaxomicin API

Optimer

Angel Biotechnology has won three further contracts with Materia Medica

Herald Scotland

Pfizer looks for buyers for Irish plants

Irish Times

Kemwell has doubled its pharmaceutical manufacturing capacity in Sweden

In-Pharma Technologist

Albemarle plans to increase revenues to $3bn in 2012

Business Week

Pfizer cuts eight manufacturing sites; cuts back at others

Pfizer plans to cease operations at eight plants in Ireland, Puerto Rico and the United States by late 2015 and reduce activities at six factories in those countries, plus Germany and Britain. The cuts will result in 6000 job losses.
Reuters

Consortium passes passes flu vax manufacturing test

A consortium led by Xcellerex has successfully demonstrated the production of purified swine flu H1 hemagglutinin (California strain) in 42 days starting from the amino acid sequence of the protein. The test results exceeded the goal for rate of production by at least 10 fold and exceeded all product quality specifications. The team, guided by BioPharm Services, combined Pfenex’s Pseudomonas fluorescens-based rapid strain engineering platform with Xcellerex’s microbial high speed process development and single-use manufacturing technologies and deltaDOT’s label free CE-based analytical technology.
In-Pharma Technologist

Cambrex's Charles City, Iowa, API manufacturing facility successfully completed an FDA GMP inspection in March

Cambrex

Wednesday, 5 May 2010

DSM Biologics has successfully scaled up of its yield-boosting XD technology from 2L to 50L using a CHO cell line, with 5-10 fold titer increases

PR Newswire

American Peptide expands peptide production capacity

American Peptide has expanded its Vista, California cGMP peptide production facility. The large-scale facility expansion includes four new peptide purification suites. The company will also add two new synthesis suites and multi-kg lyophilisation capacity.
In-Pharma Technologist

BioUetikon adds capacity

BioUetikon has installed a single use bioreactor train with 50L, 250L and 1000L capacity tanks. The train also includes complimentary scale GMP buffer and media preparation.
BioUetikon

Cambrex Q1 sales decline

Cambrex's first quarter 2010 sales declined 6.4%, compared to 2009, to $56.2m. Cambrex said the decrease is primarily due to the timing of orders for two APIs manufactured under long-term supply agreements, a customer supply chain disruption for an API manufactured under a long-term supply agreement, and a feed additive for which a contract expired. Additionally, Cambrex said lower pricing of certain generic APIs and a product utilising its drug delivery technology also contributed to the decrease.
Cambrex

Tuesday, 4 May 2010

DSM Biologics has acquired the Rhobust separation technology from Upfront Chromatograpy for use in pharmaceutical applications

PR Newswire

Syngenta is investing some €50m to expand Saltigo's capacity for crop protection agents in Leverkusen, Germany

Saltigo

SynCo Bio Partners will manufacture two additional antibodies for clinical trials for OncoMed Pharmaceuticals

PR Newswire

DSM to build Australian biopharma plant

The Queensland and Australian governments will fund Australia's first biopharmaceutical contract manufacturing facility in Brisbane. The 7000m3 facility to be built and operated by DSM will provide mammalian process development and cGMP clinical and commercial manufacturing services. The new facility is anticipated to be commissioned and operational in 2013.
In-Pharma Technologist

BPTF introduces API quality agreement

Socma's Bulk Pharmaceuticals Task Force (BPTF) has developed a template to help manufacturers and customers standardise API quality agreements and comply with US regulatory requirements.
Socma

Thursday, 29 April 2010

India tries to prevent EU clampdown on manufacturing facilities

The Indian government is lobbying hard in an attempt to prevent European lawmakers introducing legislation to require the European Medicines Agency to carry out pre-inspection of manufacturing facilities. European fine chemicals companies have been lobbying hard for the legislation which is designed to prevent low quality APIs entering the European market.
Economic Times

Wednesday, 28 April 2010

Alnylam Biotherapeutics has shown that the use of siRNA can improve biopharmaceutical manufacturing

Alnylam

Stable Q1 for DSM; outlook tough

DSM said that activity for its Pharmaceutical Products business remained low and Q1 sales were stable compared to last year. The company saw lower API sales following the loss of some products, but this was offset by the completion of the H1N1 vaccine shipments. Looking forward, DSM said it expected the full year results to be lower than in 2009 due to ongoing challenges at in the business unit said there were "some very tough quarters ahead".
DSM

Tuesday, 27 April 2010

Lower fine chemicals volumes at Albemarle

Sales for Albemarle's fine chemicals business grew 13%, compared to 2009, to $136m in Q1 2010. The company attributed this to increased volumes in performance chemicals but saw lower volumes in fine chemistry services.
Albemarle

Monday, 26 April 2010

Codexis launches IPO

Codexis launched its IPO at $13/share - the low end of its projected range of $13-15 - bringing in $78m. In its first two days of trading the shares rose to $14.
San Jose Business Journal

Avecia Biotechnology will provide oligonucleotide manufacturing for a key component of Pfizer's Macugen

Business Wire

SAFC grows 14% in Q1

Sigma Aldrich's fine chemicals business, SAFC showed sales growth of 14.3% to $152m in Q1 2010, continuing the trend seen in H2 2009. The company also took a $6m restructuring charge during the quarter related to the consolidation of some facilities and the elimination of about 100 jobs. SAFC saw double digit growth of its custom pharma products driven by higher demand for HPAPIs and viral vectors met from its recently opened California and Wisconsin facilities. The company has also seen an increase in booked orders.
Seeking Alpha

Lonza remains cautious

Lonza's Q1 demand remained consistent with 2009, but reported that volatility still persists for its custom manufacturing businesses. The company said its pipelines remain strong and it expects higher capacity utilisation this year. Additionally, it is seeing increased levels of partnership discussion in specialty areas such peptides or HAPIs and continuous high level discussions on pipeline outsourcing.
Reuters

BioInvent will stop its contract manufacturing activities to focus on proprietary drug development

GEN

Tuesday, 20 April 2010

Codexis will launch its IPO this week

New York Times

Evonik opens China API facility

Evonik has started production at its new API facility in Nanning, China. The 70m3 capacity plan, which can be doubled in size if required, will primarily supply the Chinese market. The plant has been set up in collaboration with a European pharmaceutical company for which Evonik will produce various active ingredients under a multi-year supply contract and in compliance with cGMP.
Evonik

Inno Biologics is providing manufacturing for two biosimilar products for Avasthagen

Bernama

Almac has completed its £9m of its Pharma Sevices manufacturing facility in Craigavon, Northern Ireland

Almac

Angel Biotechnology will manufacture antibodies for Materia Medica in a £1.5m deal

Pharmaceutical Business Review

Tuesday, 13 April 2010

Angel Bio profit rises in 2009; considers expansion

Angel Biotechnology saw both profit and revenues rise 55% during 2009 compared to 2008. The company reported revenues of £1.48m. Company chairman, Paul Harper said "Angel is well positioned to take advantage of the manufacturing opportunities that are emerging in an evolving business environment and are considering the Company's expansion options in the light of the increased volume of business."
InvestEgate

Dishman CFO, VVS Murthy, says the company is seeking CRAMS revenues of about $10m in 2010-11 from Japan

DNA

Monday, 12 April 2010

Ampac acquires Texas facility

Ampac Fine Chemicals has acquired a fine chemicals manufacturing facility in LaPorte, TX. The $475,000, plus costs, acquisition increases the company's capacity by 30%. The facility, which passed FDA in 2008, was completed in 2001 and significant new equipment was added in the last four years. Aslam Malik, President of Ampac said "this additional capability in Texas, which includes commercial scale hydrogenation, as well as azide, cyanide, and phosgene capabilities, fits well with our areas of established expertise in energetic chemistry and continuous processing."
Ampac

Jantibody Technologies is using Pfenex's expression technology to produce HSP-avidin fusion protein for its Jantibodies platform

Boston BioCom

Thursday, 1 April 2010

Codexis sets its IPO price between $13 and $15

CNBC

SAFC has opened its 4700m2 Verona, WI, facility

Wisconsin State Journal

Lonza will expand carnitine capacity at its Nansha, China, facility

Lonza

Ranbaxy to use Pfenex technology

Ranbaxy will develop an undisclosed biosimilar therapeutic using Pfenex's Pseudomonas-based recombinant protein expression technology. The two companies will develop production strains and the production process for the product.
Business Standard