Lonza has launched its new GS Xceed Gene Expression System, which it claims will reduce cell line development timelines by up to 6 weeks and can achieve titers of up to 6 g/L

Lonza

Siegfried to build API plant in China

Siegfried, supported by the Chinese development organisation NETDA, will build an API manufacturing plant in Nantong, China. The facility will meet cGMP standards. Siegfried said the site has space for a second phase, which may include finished dosage form production. The new facility is expected to be on-stream in 2014.
Pharmaceutical Business Review

ScinoPharm invests in cytotoxic manufacturing

ScinoPharm will invest $37.6m in the construction of a high potency cytotoxic injectable plant at Tainan Science Park. ScinoPharm said the new facility will include space for R&D, quality control, washing, sterilisation, manufacturing, filling, lyophilisation, packaging, and storage. The company expects the plant to be completed in 2014.
ScinoPharm

Aesica plans to add 100 jobs at its Queensborough, UK, facility

Aesica

Dishman to cancel SEZ project

Dishman is to exit its special economic zone in Ahmedebad, India, and sell the land for $108m. In 2009, Dishman merged its engineering SEZ into its pharma SEZ.
Economic Times

Lonza has extended its XS Technology platformm to two additional microbial systems: pacha pastoris and bacillius subtilis

Lonza

Albemarle expands API capacity

Albemarle has expanded and upgraded its API manufacturing facility in South Haven, MI. The new capacity came online on 1 June. The investment at South Haven matches the solids handling equipment with the reactor capacity and Albemare claims it will enable the company to advance its growing portfolio of custom API products.
In Pharm

Amag moves to contract manufacturing

Amag Pharmaceuticals plans to close its manufacturing facility in Cambridge, MA, and is moving to an outsourced manufacturing model. The company will reduce its workforce by 45 as a result of the disposal.
Aman Pharmaceuticals

Angel Biotechnology's Cramlington facility has successfully completed an MHRA inspection

Proactive Investors

Siegfried has appointed René Imwinkelried as head of R&D and member of the Executive Committee

Siegfried

FDA seeks to secure supply chain

The US Food and Drug Administration is seeking 100 companies to volunteer to join the Secure Supply Chain pilot programme. The programme aims to promote the safety of drugs and active drug ingredients produced outside the US. Applicants will need to meet the programme's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The FDA hopes the programme will expedite the entry of products meeting the pilot's criteria into the US and allow it to focus its resources on foreign-produced drugs that fall outside the programme and that may not be compliant.
Regulatory Focus

Hovione reposted a 24% rise in sales for the year ended March 2012 to $180m, the sixth consecutive year of sales growth

Hovione

Kalon to manufacture countermeasures

Kalon Biotherapeutics will manufacture medical countermeasures under a contract awarded to The Texas A&M University System to develop one of three US Department of Health and Human Services Centers for Innovation in Advanced Development and Manufacturing.
Kalon Biotherapeutics

Boehringer Ingelheim has rebranded its contract manufacturing business as BioXcellence

Pharmaceutical Business Review

Cytovance Biologics will develop the manufacturing platform for BiologicMD’s osteoporosis medication, PTH-CBD

Cytovance

DSM Biologics and the Australian Institute of Bioengineering & Nanotechnology will collaborate on the development of a new CHO cell line to be funded by the Queensland Government

GEN

Fujifilm Diosynth Biotechnologies to expand facilities in UK

Fujifilm Diosynth Biotechnologies is further increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell line development and process development, and the addition of a new multi-product cGMP facility in Billingham, UK. The company said work has commenced on a state-of-the-art cGMP cell bank and 1000L biologics manufacturing facility based upon single-use technology for both upstream and downstream operations. The cell bank manufacturing facility is expected to be available from Q2, 2013 and the mammalian cell culture biologics manufacturing facility is expected to be validated and fully operational in the second half of 2013.
Fujifilm Diosynth Biotechnologies

CMC Biologics' Bothell, WA, facility has received GMP certification from the UK Medicines and Healthcare products Regulatory Agency

PR Newswire

Codexis has been awarded the annual Presidential Green Chemistry Challenge Award for its simvastatin manufacturing process

Codexis

DSM antibody deal

DSM Pharmaceutical Products will use its XD high cell density process technology to produce antibodies for a major pharma company at its Groningen, The Netherlands, and Brisbane, Australia facilities.
PR Newswire

Evonik IPO suspended

Reuters

Lonza has completed the installation of a new GMP clean room in Houston, Texas, for its vaccines and gene therapy business

Lonza

Piramal negotiating to acquire Cambridge Major

Piramal Healthcare is currently in negotiations to acquire Cambridge Major for around $200m. The report appears to confirm earlier comments by the company. A source lose to the situation, quoted in Financial Express, said "Early stage negotiations are on and it will take a while to conclude the deal." Cambridge Major has not commented on the speculation.
Financial Express

Dalton Pharma Services will manufacture chemicals for use in Clarity Pharmaceuticals’ PET-based companion diagnostics and radio-immunotherapeutics programmes

Pharmaceutical Business Review

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