Wacker Biotech has completed a feasibility study to produce XL-protein's PASylated therapeutic proteins

GEN

Ubichem adds capacity in Hungary

Ubichem has added a new manufacturing site in Budapect, Hungary. Ubichem Pharma Manufacturing's 55,000² facility will produce starting materials, intermediates and other fine chemical products for pharma and non-pharma applications.
Ubichem

SAFC plans to consolidate its global chiral chromatography screening and small scale purification operations at its Pharmorphix laboratories in Cambridge, UK, by July

SAFC

Evonik IPO may be cancelled

Reuters

The US FDA has sent warning letters to eight companies for failing to register manufacturing facilities

In-pharma Technologist

Strong sales for Johnson Matthey

Johnson Matthey reported that sales for its fine chemical division rose 16% to £285m and operating profit rose 24% to £69.7m. The company said this was boosted by strong demand and supported by a very strong performance from its API manufacturing businesses. Sales in API manufacturing rose 18% to £206m.
Johnson Matthey

PacificGMP has successfully completed the manufacture of Vasgene Therapeutics' recombinant fusion protein for use in a phase I clinical trial

PR Newswire

Abbott's custom manufacturing business will be spun out alongside the company's pharmaceutical products into Abbvie

Outsourcing Pharma

Gallus Biopharmaceuticals has completed a $20m expansion of its clinical manufacturing and process development facilities at its St. Louis, MO, site

St Louis Business Journal

Carbogen Amcis' Aargau facilities have received SwissMedic authorisation to manufacture drug substances for commercial purposes following GMP inspections

Carbogen Amcis

Piramal looks to acquire

Piramal Healthcare is looking to expand its contract manufacturing business and is already in talks with some contract manufacturing companies in Europe and the US. Chief operating officer, Vijay Shah, said the company wants to scale up the contract manufacturing business to become one of the world's top five.
Live Mint

Codexis has appointed John J Nicols as President and Chief Executive Officer

Codexis

Siegfried adds sterile filling

Siegfried has acquired Alliance Medical Products in Irvine, CA, to add sterile filling services. Siegfried paid $58m in cash with a contingent earn-out consideration subject to AMP meeting defined profitability goals for the fiscal year ended December 31, 2013.
Siegfried

Profits fall at Angel

Angel Biotechnology has reported revenues of £3.456m for the peered ended 31 March. Profits fell from £1.9m to £1.2m partly as a result of the expenditure prepare its Cramlington facility for its initial MHRA inspection. The company plans to continue consolidating its businesses in the coming year.
Proactive Investors

Evonik IPO to proceed

Evonik's owners RAG and CVC plan to go ahead with an IPO of the chemicals unit in June. Reports suggest the firm could raise €5bn after delaying the IPO last year.
Reuters

Albemarle is increasing prices for all grades of ibuprofen by 15%

Fierce Pharma Manufacturing

Angel Biotechnology has successfully completed an MHRA inspection at its Pentlands facility

Angel Bio

Ian Shott has been appointed as president of AMRI Europe

Albany Business Journal

Codexis and Merck extend collaboration

Merck has extended its catalyst and process development collaboration with Codexis to 2015. Merck will use Codexis' enzyme products to develop more cost- and resource-efficient manufacturing processes for its pipeline of therapeutic candidates. To date Merck has evaluated the use of enzymes across programs in various stages of development and the companies have collaborated to develop enzymes for custom reactions such as for sitagliptin.
Pharmaceutical Business Review

Recipharm to expand

Recipharm plans to use a new €90m loan facility to acquire niche CDMOs, invest in existing facilities and build long term partnerships with major pharmaceuticals companies.
Outsourcing Pharma

The head of RAG has told the German media that Evonik will not be sold "under value"

Bloomberg

Lonza will provide process development and scale-up efforts for manufacturing viral vectors for Avalanche Biotechnologies gene therapy

GEN

ReNeuron has contracted Angel Biotechnology to provide GMP stem cell manufacturing services for completion of its stroke clinical trial

Angel Biotechnology

Carbogen Amcis drags on Dishman

Dishman Pharmaceuticals and Chemicals sales for FY 2012 rose 9% to $208m although profits fell 29% to $10m. The Carbogen Amcis business reported a Q4 turnover of $77m with a loss of $3m although the company expects the unit to grow significantly in terms of topline and bottomline in its 2013 year.
Money Control

Codexis granted patent

Codexis has been granted a US patent covering biocatalytic processes for the preparation of fused bicyclic proline compounds. These compounds are used to make key intermediates in the synthesis of leading hepatitis-C therapeutics.
Codexis

API Corporation has added the pharmaceutical ingredient manufacturing and sales operations of Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma

Codexis reported Q1 2012 product revenues of $15.2m up 17% on 2011 driven by increased sales of atorvastatin-related intermediates

Codexis

AmPac sales revenues rise in Q2

American Pacific's fine chemical division reported Q2 2012 sales of $20.6m up 28% from 2011 primarily due to strong revenues of anti-viral products. However, this was offset by lower oncology products revenues.
In-pharma Technologist

Angel Biotechnology has acquired the Devro Medical collagen manufacturing business for £200,000

BBC

Mixed Q1 for AMRI

AMRI reported mixed results for its manufacturing units in Q1 2012. Sales fell 7% to $9.8m for its development/small scale manufacturing, and rose 6% to 23.2m for the large scale manufacturing business.
AMRI

BASF has acquired omega-3 fatty acid maker Equateq

In-pharma Technologist

Pharma weak for DSM

DSM has reported weak Q1 performance in its pharmaceutical facing businesses. However, the company said the first signs of improvement are visible. DSM attributed its 7% growth in sales to a better performance at DSM Pharmaceutical Products and slightly better prices at DSM Sinochem Pharmaceuticals.
DSM

Wacker's Biosolutions unit reported a 9% increase in Q1 sales to €41.2m

Wacker

Lonza's Q1 in line with expectations

Lonza reported its business performance was in line with expectations in the first quarter of 2012 and that its custom manufacturing business has continued pipeline development and signed new contracts ranging from pre-clinical to commercial products. The company also reported that capacity utilisation in both chemical and biological manufacturing was 75%.
Lonza

Carbogen Amcis looks east

Dishman Pharmaceuticals & Chemicals is refocussing its Carbogen Amcis subsidiary by expanding from its traditional Europe and the US markets towards Japan and other territories. In addition, Dishman has reduced manpower at Carbogen Amcis bringing down the wage bill significantly. The company said these changes are expected to strengthen Carbogen Amcis' financial performance in the fourth quarter of the fiscal 2012.
Business Standard

Cambrex Q1 sales rise

Cambrex reported a 14% increase in Q1 sales to $70.6m and EBITDA increased by 41% to $15.6m. The company attributed the increase in sales to higher volumes of controlled substances and generic APIs.
Cambrex

Pfenex anthrax contract renewed

US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) has exercised its option to extend its contract with Pfenex to develop a production strain and process for the production of bulk recombinant protective antigen (rPA) from anthrax. Under the contract Pfenex will continue to develop an rPA-based anthrax vaccine from rPA produced in Pseudomonas fluorescens. To date, Pfenex has demonstrated that a strongly immunogenic, stable and protective form of rPA could be expressed and recovered from the highly efficient fermentation of a strain of P. fluorescens engineered to produce rPA.
Pfenex

Cambrex’s Charles City, Iowa, API manufacturing facility has successfully completes and FDA GMP inspection

Pharmaceutical Business Review

Ark plant receives approval

The Finnish Medicines Agency (FIMEA) has extended Ark Therapeutics' GMP certification to include its newest and largest production facility in Kuopio, Finland. The 650m² facility has been designed for larger scale production from suspension cell cultures utilising state-of-the-art single use systems and includes an automated fill and finish line capable.
Ark Therapeutics

Strongest Q for SAFC

In its strongest quarter ever, SAFC reported sales of $197m in Q1 2012. The company said the organic sales growth rate for SAFC in the first quarter was in the low single digits but it expects sales growth to move from low-mid single digits in the first half of the year to low double digits for the second half.
Seeking Alpha

The US FDA has approved Codexis' manufacturing process for sitagliptin the API in Merck's diabetes drug Januvia

Bloomberg BusinessWeek

Dalton Pharma Services will manufacture an antiviral agent developed by Defence Research and Development Canada

Dalton Pharma

Albemarle reposted Q1 2012 sales of $190m for its fine chemicals business, up 7% on 2011 and income of $39 million, up 31%

Seeking Alpha

Kemwell Biopharma has added a 750m2 cGMP pilot plant at its Bangalore, India facility

Outsourcing Pharma

AMRI will develop and manufacture Biota Holdings influenza antiviral CS8958

Albany Times-Union

£800k deal for Angel

Angel Biotechnology will develop and manufacture a recombinant interferon product for TransGenRx at its Cranlingon, UK, faulty. As part of the £800,000 deal Angel will work to attain acceptable expression levels on which to establish a GMP manufacturing process, which would then be conducted by Angel.
Angel Biotechnology

Helsinn's Biasca, Switzerland, facility underwent a successful FDA inspection for the production of APIs and HPAPIs

CheManager

Aesica's Queenborough, UK, site has passed an FDA inspection for the production of solid dosage forms

Manufacturing Chemist

Lonza will manufacture Agennix’s dendritic cell mediated immunotherapy, talactoferrin, at its microbial manufacturing facility in Kouřim, Czech Republic

Pharmaceutical Business Review

Lonza will perform process development for Immutep's lead clinical development-stage cancer therapy

Genetic Engineering and Biotechnology News

Avecia Biotechnology has changed its name to Nitto Denko Avecia

Avecia

Merck and Codexis have developed an efficient, enzyme-based production method for a key intermediate in the production of boceprevir

InPharm

Lonza has appointed Richard Ridinger as its new chief executive officer

Bloomberg

Sigma-Aldrich acquires Research Organics

Sigma-Aldrich has acquired Research Organics, Inc. to expand its buffer production capacity and to increase its portfolio of raw materials for the biopharmaceutical and diagnostic markets. Sigma-Aldrich will merge Research Organics into its SAFC business unit.
St Louis Business Journal

CIA seeks companies for UK pavilion at CPhI

The UK's Chemical Industries Association is seeking expressions of interest from UK-based companies offering products and services within the fine chemical industry interested in exhibiting on a UK pavilion at CPhI in Madrid, Spain, during October.
For more information contact CIA

Dottikon has established a US subsidiary Dottikon ES America Inc to meet US business development requirements

Dottikon

Fujifilm Diosynth Biotechnologies expands R&D capabilities

Fujifilm Diosynth Biotechnologies has completed the first phase of a £3m investment in new equipment and laboratories at its Billingham, UK site. The company has refitted its microbial fermentation laboratory to including eight new in-situ sterilisable 20L fermenters and a number of bench-top high-throughput units. Additionally, the company has added a new suite of R&D laboratories for process development work and plans to further additions in Billingham and at its North Carolina site.
Contract Pharma

Angel's Cramlington facility runs again

Angel Biotechnology has completed the re-commissioning of its Cramlington, UK, facility. The company is now seeking to transfer processes from its Edinburgh facility en route to GMP certification.
Angel Bio

RAG looking for €15bn value in Evonik IPO

Reuters

Saltigo realignment hits Lanxess

Lanxess Q4 2011 income fell to €5m, down 80% from €26m in 2010. The company attributed this to a €20m charge for the realignment of the pharma business of the Saltigo business unit.
Lanxess

AMRI will close its operations in Budapest, Hungary, on 30 March, resulting in the loss of 100 jobs

Outsourcing Pharma

Novasep completes recapitalisation

Novasep has completed its previously-announced recapitalisation. The €310m arrangement includes €30m of new capital invested by France’s strategic investment fund, which has become a shareholder in Novasep. Additionally, Azulis invested 3 million euros in equity. The company said it now has more than €40m in cash available for financing growth projects.
Novasep

Manufacturing oversight bill proposed in US

In an effort to improve the tracking of drugs imported into the US, Senator Michael Bennet has published a discussion draft of a bill that would strengthen manufacturer quality standards by improving tracking of foreign manufacturing sites and requiring all manufacturers to register with FDA. The Senator also proposes that manufacturers submit information on the regulatory status, facility information, cGMP and "any other information deemed necessary" for imported drugs before entering the country.
US Senate

Angel Biotechnology is seeking to raise up to £1m through a placing of shares

StockMarketWire

Stuart Needleman has been named President and Chief Operating Officer of Aptuit following promotion from President, Scientific Operations

Aptuit

Recipharm to commercially manufacture Plenadren

Recipharm will commercially manufacture Plenadren for ViroPharma. As part of the agreement, ViroPharma will investing in new equipment at Recipharm to increase the manufacturing capacity for Plenadren. Although Recipharm will be able to use the new equipment for other projects, manufacturing for ViroPharma will be the highest priority.
Recipharm

DSM extends contract with Agennix

DSM Pharmaceutical Products has extended its process development and manufacturing agreement with Agennix to include commercial manufacture of talactoferrin, an oral dendritic cell mediated immunotherapy.
Pharmaceutical Business Review

The WHO has joined the inspections alliance formed by the EMA, FDA and TGA

In-Pharm

Evonik IPO plans revived

Evonik's partial owner CVC has said that the company could now be listed by the end of June. A partner in CVC said that the robust start to the markets this year meant that the conditions for an IPO were more suitable now than when the Evonik IPO was shelved last year.
Reuters

Hovione has appointed Colin Minchom as Vice President of its Particle Design Business Unit

Hovione

GE Healthcare has acquired biopharmaceutical manufacturing systems manufacturer Xcellerex

In-pharma Technologist

Lonza will produce pre-clinical monoclonal antibody material for LegoChem Biosciences at its Cambridge, UK, facility

Lonza

Angel Biotechnology has appointed Stewart White as acting CEO

Angel

Emcure Pharmaceuticals will manufacture Roche's Herceptin and MabThera for the Indian market

Economic Times

Boehringer expands biopharma capabilities

Boehringer Ingelheim has invested €17m to expand its biopharmaceutical development and manufacturing capabilities in Biberach, Germany and Vienna, Austria. The company said the expansions will enhance state-of-the art cell line development and process development services for the contract manufacturing business. Additionally, the company has expanded its current GMP cell banking, process science, cell line development and quality laboratories.
European Pharmaceutical Review

Lonza will produce phase I clinical material for Eclipse Therapeutics' novel cancer therapeutic antibody, ET-101 at its facility in Slough, UK

Lonza

Scott Martin has been promoted to vice president, Fine Chemistry, at Albemarle

Albemarle

Girindus partners with Axolabs

Girindus has partnered its oligonucleotide manufacturing with Axolabs analytical capabilities to offer a complete service solution for therapeutic oligonucleotides from early discovery and preclinical development through clinical stages and into commercialisation.
GEN

Siegfried Rhein will invest $20m to expand its generic drug production capabilities in Queretaro, Mexico

CNN Expansion

Boehringer Ingelheim will manufacture preclinical and phase I supplies for Xencor's biosuperior monoclonal antibodies

Pharmaceutical Business Review

Jubilant HollisterStier signs four contracts

Jubilant Life Sciences subsidiary, Jubilant HolisterStier, has signed manufacturing contracts, worth over $90m in total, with four life sciences firms. The company will manufacture sterile parenteral products for the US and European markets.
Economic Times

Codexis appoints interim CEO

Codexis has appointed Peter Strumph, Senior Vice President and Business Head of Pharmaceuticals, as interim CEO following the surprise decision by Alan Shaw to step down. The company said Shaw resigned to pursue other interests, but will will continue to serve as a special advisor to the Board of Directors.
San Francisco Business Journal

Asymchem adds capacity

Asymchem has completed phase 1 of a new large scale manufacturing facility in Dunhua, China. Operating under the name Jilin Asymchem Laboratories Co. Ltd the $20m facility includes 5,000-20,000L vessels for the limited cGMP manufacture of raw materials to intermediates. A second phase, which will be completed in July 2012 will add a second module for a total capacity of 532m³. The third phase, due online in October 2012, will increase capability through GMP manufacturing of APIs and API intermediates. Asymchem plans a further $12m investment in Dunhua between 2012 and 2014 for additional downstream commercial projects.
Pharmaceutical Business Review

OmniChem expands in Belgium and India

OmniChem has commissioned a new facility for the development and manufacturing of HPAPIs and intermediates in Wetteren, Belgium. The new facility has increased OmniChem's capacity in class 5 HPAPIs by 11,200-liter reactor capacity. Additionally, OmniChem's Indian joint venture Granules-OmniChem has broken ground on a $20m manufacturing facility in Visakhapatnam.
OmniChem
Business Standard

Chemoxy spins out from Dow

The UK facilities of Dow Haltermann Custom Processing have been spun out from Dow Chemical with a management buy-out backed by the Royal Bank of Scotland. The business, which has sites at Middlesborough and Billingham in the UK, has been renamed Chemoxy International, the company's former name. The firm will employ about 80 people an is seeking to grow by 5-10% this year. Managing director, Ian Stark, said "we are going to be more agile as an SME and we’re looking to bring back on line some plants that were idle a few years ago."
Speciality Chemicals

Carbogen Amcis' Bubendorf, Switzerland API manufacturing site has successfully completed a routine US FDA inspection

Contract Pharma

Lonza to form South African JV

Lonza has confirmed it is negotiating with the South African Government to establish a $206m JV, called Ketlaphela, for the establishment of a manufacturing facility for anti-retroviral medicines. The discussions are still at an early stage and nothing has been signed. South African Science and Technology Minister Naledi Pandor has said production should start in 2016 and create 2200 jobs. The South African Industrial Development Corporation and other state institutions will invest $129m, Lonza will invest more than $64m and South Africa's state chemical company, Pelchem (Pty) Ltd., will contribute land and facilities worth $13m. Lonza said that the discussions are still at an early stage and nothing has been signed.
Reuters-Yahoo

SAFC continues to grow sales

Full year sales at Sigma Aldrich rose 10% to $2.5bn, with the SAFC business growing 9% during the year. The company said it expected the SAFC business to show low to mid single digit growth in the first half of the year and low double digit growth in the second half of the year as additional capacity comes on line in China and Taiwan.
Seeking Alpha

Revenues rise for AMPAC

AMPAC reported a 55% increase in fine chemicals segment revenues to $21.5m in its Q1 2012. Dana Kelley, AMPAC vice-president, CFO and treasurer, said that revenues from antiviral products were the primary contributor to the rise as the 2012 first quarter included no antiviral product revenue. Joe Carleone, AMPAC president and CEO, said the company had recently agreed to produce controlled substances for a large pharmaceutical customer and will soon be conducting a full scale validation of a chemical product in this area.
Seeking Alpha

Lonza's new factory concept

Lonza is establishing a new manufacturing concept at its Vis, Switzerland site. The company said that continuous flow and microreactor technologies will allow it to offer increased flexibility and capacity for the development and manufacture of APIs. Lonza added that the facility will be ready for full operation in June 2012.
Manufacturing Chemist

Contract manufacturing sales up for AMRI

Contract manufacturing sales at AMRI rose in 2011. The company reported a rise of 4% to $36m for its development and small scale manufacturing and 20% to $95.6m for large scale manufacturing.
AMRI

Sales rise at Cambrex; looks to acquire

Cambrex reported a sales rise of almost 6% to $67.1m in Q4 2011, which the company attributed to increased demand for an API manufactured under a long-term supply agreement, a recently approved innovator product, higher sales of generic APIs, and higher volumes of controlled substances and products utilising its drug delivery technology. Cambrex CEO, Steven Klosk, said the company is looking to add further capabilities in generic finished products.
In-pharma Technologist

Hikal's Jigani, Bengaluru, API manufacturing facility has successfully completed its third US FDA audit

Pharmabiz

Codexis looks to future

Codexis' full year 2011 product revenue rose 49% to $49.0m as a result of increased sales to both generic and innovator pharmaceutical customers. Codexis President and CEO, Alan Shaw, said that in 2012 the Codexis' customers received FDA and EMA approvals for three new on-patent drugs using the company's technology. Shaw said he expects to see improved sales growth in 2012. Additionally he said Codexis is expecting the FDA to approve the manufacturing process for blockbuster pharmaceutical product, which has approaching $4bn in sales. He sees additional growth from increased volumes of generic atorvostatin using the company's technology and more companies using their products in their process development.
Codexis

New contract for Angel

Angel biotechnology has signed three new manufacturing contracts with Materia Medica Holding, worth £4.5m. Angel will start the projects at its Edinburgh facility before transferring later this year to its refurbished, larger site at Cramlington, UK.
The Herald

Aesica to expand HPAPI capabilities

Aesica is to upgrade its API manufacturing capabilities to enable the company to manufacture high potency APIs at commercial scale. Following the upgrade, Aesica will be able to manufacture SafeBridge Category 3 API and formulated products from pilot to commercial scale at two of its sites in Europe.
Aesica

OctoPlus will provide formulation development and manufacturing for Ferring Pharmaceuticals

Pharmaceutical Business Review

Q3 sales rise at Johnson Matthey

Johnson Matthey's fine chemicals division reported sales up 15% to £62m in its Q3 ended 31 December 2011. The company said its API manufacturing business performed well aided by sales of a new API for the treatment of drug addiction. Looking forward Matthey said the underlying performance of the division is more predictable and it continues in line with expectations.
Johnson Matthey

SAFC gets BioReliance

Sigma-Aldrich has completed its acquisition of BioReliance from Avista Capital Partners for $350m. BioReliance's services will be folded into Sigma-Aldrich's SAFC custom manufacturing and services business unit.
Maryland Daily Record

Indian manufacturing pact for DSM

Mumbai, India-based Indoco Remedies will manufacture eight APIs for DSM's pharmaceutical products business unit. DSM said the alliance will leverage Indoco's product development and cGMP manufacturing capabilities and DSM's market access. Additionally DSM said the deal fits with its global expansion plans.
Hindu Business Line