The US FDA has announced its cGMP requirements for manufacturing combination products

RAPS Regulatory Focus

SFDA to survey API exports

China's State Food and Drug Administration (SFDA) will require API manufacturers in the country to provide details of their APIs' names, license numbers and major export destinations and to tell the authorities whether they hold a European Union GMP certificate.
Pharma Times

Sobi has received approval from the European Medicines Agency for the manufacture of the drug substance for Kineret at Boehringer Ingelheim's Vienna, Austria, facility

Sobi

Serum to add diphtheria toxin plant

Serum Institute of India has commenced the construction of a new large scale cGMP production facility to manufacture CRM197, a non-toxic mutant of diphtheria toxin, for Phenex's Reagent Proteins division. The new facility, which will be able to produce 50kg/year of CRM197 using Pfenex's pseudomonas flourescens expression technology, is due to open in 2014.
GEN

Mitsui & Co Ltd has increased its stake on Arch Pharmalans to 31.96% having acquired a further $68.8m of shares

Mitsui

Almac has added a non-GMP formulation development facility and two new analytical laboratories at its Craigavon, Northern Ireland, site

Speciality Chemicals

Lonza to evaluate Barofold tech

Lonza will evaluate BaroFold’s PreEMT high pressure refolding technology in its microbial development and manufacturing plant in Visp, Switzerland. As part of the agreement Lonza has an option to extend the platform evaluation to GMP production analysis.
Chem Manager

Amgen has licensed DSM Pharmaceutical Products XD high cell density process patents for the manufacture of recombinant proteins and antibodies

In-pharma Technologist

Samsung BioLogics commits $2bn to CMO business

Samsung has committed $2bn to its biologics custom manufacturing business, Samsung BioLogics. The company, established in 2011, completed construction of its first mammalian cell culture facility in December 2012. The 30,000L facility in the Songdo Free Economic Zone near Seoel, Korea, includes six 5000L reactors, as well as fill and finish and quality control capabilities. The company plans to add another 150,000L of mammalian cell culture manufacturing by 2014 and 40,000 of microbial fermentation by 2016 said TH Kim, President and CEO of Samsung BioLogics, at the JP Morgan conference in San Francisco, earlier this week. Kim said that the business brings together Samsung's construction and manufacturing experience with biologics expertise hired from biotech and other cmos. He said he believes the company can produce biologics at lower cost than competitors and still deliver quality and value for customers.
JP Morgan

Lonza to add ADC capacity

Lonza will expand manufacturing capacity for antibody drug conjugates at its Visp, Switzerland, site. The company will invest CHF14m in facilities that are designed to handle both biological species and highly potent cytotoxic small molecule drugs. Lonza said the new capacity is expected to be complete in Q2 2014.
In-pharma Technologist

Aptuit will manufacture Aegerion Pharmaceuticals lomitapide API for commercial supply

Aptuit

Sutro Biopharma will use its cell-free protein synthesis technology to produce two undisclosed vaccine candidates for Sanofi Pasteur

Sutro Biopharma

Questcor Pharmaceuticals will acquire BioVectra for an upfront payment of Can$50m

Questcor

FDA approvals up

The US Food and Drug Administration (FDA) approved 39 products in 2012 - the highest number for 15 years. Of these 35 were drugs, 15 of which targeted new mechanisms of action. Seven of the drugs offer treatment options for previously unmet medical needs.
Drug Baron

Cambridge Major acquired by American Capital

American Capital has acquired Cambridge Major from its previous private equity partner, Arlington Capital Partners for $212m. Cambridge Major said that American Capital brings significant resources, relationships, and capital to fuel the company's continued growth, both organically and through acquisition.
Alt Assets

UMN Pharma and its subsidiary Unigen will produce a number of biosimilars using Catalent’s GPEx cell lines

Catalent

Sartorius Stedim Biotech will market and sell Lonza’s media and buffers used in the manufacture of protein-based therapeutics and vaccines

GEN

Aesica looks for new API processes

Aesica has partnered with Durham and Leeds Universities to identify and commercialise alternative technologies for API manufacturing processes. The partnership is supported by the METRC Innovation Award that supports new research between universities and companies in the fields of nanotechnology, science and engineering.
Contract Pharma

Ampac revenues rise

Ampac's fine chemical segment reported FY12 revenues of $111.5m up 25% on 2011. The company attributed this improvement to a recovery from a lag in antiviral product sales in 2011 and to growth from existing or new products.
Seeking Alpha

IGIG acquires Tessenderlo sites

International Chemical Investors Group has acquired the pharmaceutical ingredients activities of Tessenderlo. ICIG has acquired the facilities in Calaire, France, and Farchemia, Italy, to International Chemical Investors Group (ICIG), a private industrial holding company for an undisclosed sum.
In-pharma Technologist

Genmab desperate to sell

Genmab has reduced the fair value of the Brooklyn Park, MN, facility it has been trying to sell for the last few years from $58m to zero. The company will now enter into an aggressive sales process with the aim of closing a transaction in Q1 2013.
Pharma Bio Source

Evonik is cutting 45 jobs at its Tippecanoe, IN, laboratories

JC Online

MHRA to seek API details

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) will soon contact UK-based marketing authorisation holders to request data on APIs imported into the UK to ensure they are manufactured in accordance with the EU GMP or, if imported into the EU, with equivalent rules. The MHRA recently said that almost 1200 API plants may require inspection to meet the EU rules.
MHRA

Angel Biotechnology's losses for its H1, ended 30 September, rose to £2.86m as revenues fell to £1m

Business 7

Boehringer Ingelheim will develop the cell line and manufacture Apexigen's APX005 humanised monoclonal antibody for phase I clinical trials

Boehringer Ingelheim

Isochem acquires Wychem

Isochem has acquired kg-scale fine chemical intermediate supplier Wychem. Isochem said the acquisition allows it to offer customers continuity of service and capacities ranging from the kilogram to a hundred metric tons.
Isochem

Dottikon sales and losses increase in H1

Dottikon's first half 2012/13 sales increased 22% to CHF37.7m. However, the company said its production output fell 9% due to unexpected delays in projects and products. Dottikon reported a loss of CHF4.0m for the period.
Dottikon

Carbogen Amcis' Riom, France site for sterile manufacture of fill-finished parenteral drugs was successfully certified by the French Health Agency

Carbogen Amcis

Cadila Healthcare will manufacture intermediates, APIs and finished dosages for some Zambon Group drugs

Financial Express

Kemwell will provide contract manufacturing for Mercury Pharma Group from its facility in Uppsala

MyNewsDesk

AMRI is being sued in Hungary for unpaid lease payments following the closure of its Budapest facility earlier this year

Albany Times Union

Hovione drug solubility collaboration with Solvias

Hovione will combine its drug delivery expertise with Solvias' solid state chemistry capabilities in a collaboration focused on the development and GMP supply of pharmaceutical co-crystals. Hovione will use Solvias’ co-crystallisation expertise and crystal design solutions to overcome poor bioavailability and other drug delivery challenges.
Hovione

Switzerland is the first country to gain acceptance to the EU list of countries with a regulatory framework applicable API manufacture

EU

Matthey fine chems perform well in H1

Johnson Matthey reported sales fell 2% to £138m in H1 for its fine chemicals while operating profit rose 14% to £37.2m. Of this, sales in Matthey's API manufacturing business fell 3% to £99m.
Johnson Matthey

Sigma-Aldrich is re-aligning its business segments and SAFC will be reamed the SAFC Commercial Markets Business Unit

St Louis Business Journal

EFCG calls for mandatory inspections

The European Fine Chemicals Group (EFCG) has proposed global harmonisation of the rules and regulations governing the manufacture of active APIs. The trade group wants to level the worldwide playing field and ensure the quality of APIs and the medicines containing them. EFCG has proposed mandatory inspections for all global API manufacturers through a mutual recognition agreement (MRA) approach managed by national regulatory authorities to share scarce inspection resources and to avoid duplication of effort.
Pharmaceutical Technology

Recipharm will develop and manufacture a parenteral veterinary product for Vetcare

Recipharm

Fujifilm Diosynth Biotechnologies will manufacture ThromboGenics' Jetrea following FDA approval

Fujifilm Diosynth Biotechnologies

Boehringer Ingelheim will install a laboratory-scale reactor of BaroFold’s Pressure Enabled Manufacturing Technology at its microbial facility in Vienna, Austria

Pharmaceutical Business Review

Cytovance Biologics will manufacture Selexys Pharmaceuticals' SelG1 monoclonal antibody for a phase II clinical study

Cytovance

Boehringer Ingelheim will develop E coli production strains and manufacture toxicology and clinical stage material for Molecular Partners’ DARPin pipeline

Molecular Partners

Nitto Denko Avecia to acquire Girindus contract manufacturing business

Nitto Denko Avecia will acquire Girindus America's oligonucleotide and small molecule API contract manufacturing business. Nitto Denko Avecia said the acquisition will allow it to offer customers an expanded range of manufacturing capabilities, as well as a second manufacturing facility for security of supply.
Nitto Denko Avecia

ProBioGen has launched a set of engineered, royalty-free biopharmaceutical CHO production cell lines

ProBioGen

Pharma sales flat for DSM

DSM's pharma business reported net sales growth of 1%. However the company said the results were adversely impacted by an uneven delivery pattern at DSM Pharmaceutical Products and by lower margins at DSM Sinochem Pharmaceutical, despite higher volumes. DSM also said it expected business conditions in pharma to remain challenging for the remainder of the year.
DSM

Kemwell will manufacture biosimilar drugs for Avesthagen

Hindu Business Line

Mixed sales performance at AMRI

AMRI reported a 20% fall in sales to $7.4m for Q3 2012 for its development and small scale manufacturing business. The company reported a 14% rise in sales t $9.3m for large scale manufacturing.
AMRI

Cambrex reported Q3 2012 sales rising 2.8% to $59.8m

Cambrex

Angel Biotechnology has signed a new deal to expand CTX cells and produce the GMP drug substance batch for ReNeuron

The Scotsman

Wacker Biotech will provide its customers with access to XL-protein's PASylation platform for the production of biopharmaceuticals with extended plasma half-lives

Wacker

Cytovance Biologics will develop the process an provide cGMP manufacturing for Fountain BioPharma's monoclonal antibody for the treatment of allergy

Pharmaceutical Business Review

Lonza to cut jobs at Visp

Lonza will cut 400 jobs at its Visp, Switzerland, site and another 100 in global support functions. The company said that its Q3 2012 performance was on-track and reported steady demand resulting in capacity utilisation as expected in both its chemical and biological custom manufacturing.
Business Week

SAFC will provide pre-formulation services for CrystalGenomics next-generation non-steroidal anti-inflammatory drug API

Pharmabiz

Oxford BioMedica has launched OXB Solutions to provide contract manufacturing and development from its Oxford, UK facility

OXB Solutions

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

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

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

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

CHP adds capacity

Cedarburg Hauser Pharmaceuticals has expanded its Wisconsin API plant by 50% to meet commercial demand. The company has also added reactor and chiller capacity for GMP cryogenic reactions, made improvements to the air handling systems, installed a reverse osmosis water system, improved isolation capabilities, and upgraded their Emerson DeltaV Digital Automation System.
Cedarburg Hauser Pharmaceuticals

Lonza will develop and manufacture Intellect Neurosciences antibody drug conjugate Conjumab-A

Intellect Neurosciences

Market rumours suggest that BASF or Sabic may be looking to acquire Lonza for around £2.2bn

Lonza

17 Socma member facilities have qualified for the ChemStewards Excellence Tier

Socma

Carbogen Amcis has partnered with ADC Biotechnology to provide customers with seamless development and manufacturing services for antibody drug conjugates

Carbogen Amcis

Gallus BioPharmaceuticals and Roslin Cells will provide manufacturing services cell therapy-based biopharmaceutical products customers

PR Web

India plans to establish a competent authority to meet EU API import requirements from July 2013

In-pharma Technologist

Dishman has licenced statin synthesis technology from Redx Pharma to enhance its CRAMS portfolio

Business Standard

The European Commission has revised its GMP guidelines to align them with ICH Q10

In-pharma Technologist

Navidea blames manufacturer

Navidea Biopharmaceuticals attributed the Complete Response Letter from the US Food and Drug Administration regarding its NDA for Lymphoseek to issues with third-party contract manufacturers. In November 2009, Navidea appointed Reliable Biopharmaceutical Corporation for the manufacture and supply of the API for Lymphoseek. Final product manufacturing including final drug formulation, lyophilization and packaging processes for Lymphoseek is performed by OSO BioPharmaceuticals Manufacturing LLC.
Reuters

Boehringer Ingelheim implements disposable biomanufacturing

Boehringer Ingelheim has implemented single-use biomanufacturing at its mammalian facilities worldwide. The system can incorporate different commercially available single-use systems in 100L and 500L GMP facilities for clinical material supplies or for non-GMP process development.
Biopharmaceutical Business Review

Cambridge Major to add capacity

Cambridge Major Laboratories is to expand its large scale API manufacturing facility in Germantown, WI, as a result of growth in demand. The company will add reactor capacity and isolation equipment. Brian Scanlan, President & CEO of Cambridge Major, said that the company's "invest in the West" policy continues to bear fruit. He added that the company is "very well positioned to support both increasing demand for our commercial products as well as our healthy pipeline of API's in later phases of clinical development."
Milwaukee Business Journal

Codexis to cut 133 jobs after deal with Shell terminated

In-pharma Technologist

GE Healthcare has launched a range of modular biomanufacturing facilities

In-pharma Technologist

Piramal Healthcare is rumoured to be in talks to acquire Ind-Swift Laboratories' CRAMS business and facilities

Business Standard

Aesica Partners with University of Bradford

Aesica has partnered with the Centre for Pharmaceutical Engineering Science at the University of Bradford. Aesica will benefit from the University's research facilities and the University will gain access to Aesica's GMP manufacturing facilities.
Manufacturing Chemist

Mike Ironside has been appointed as General Manager, TTC, at Hovione

Hovione