Wednesday, 6 March 2013

Ashland expands R&D centre

Ashland plans to expand its formulation development and GMP contract manufacturing services for solid dispersions and oral solid dosages at its pharmaceutical R&D centre in Wilmington, DE. The expansion, which aims to support early-stage clinical trials, will include spray drying and extrusion processes previously located in Columbia, MD. Ashland said it wool relocate approximately 20 positions from Columbia to Wilmington as a result of the expansion, which is expected to be operational by summer 2014.
Manufacturing Chemist

Strong sales at Siegfried

Siegfried has reported a 12% rise in sales to CHF367.8m for the 2012 financial year. During 2012 Siegfried opened a high potency drug production suite in Zofingen, Switzerland, made progress with plans to modernise its production facility. The company plans to start construction of a production plant in Nantong, China, during 2013.

DSM Pharmaceutical Products has signed a three-year master supply agreement to produce sterile products at its Greenville, NC, site for Eisai


SAFC is adding large-scale production of bulk dry power media and reagents at its manufacturing plant in Irvine, Scotland

Outsourcing Pharma

Ajinomoto has entered the biopharmaceutical development and contract manufacturing arena by acquiring Althea Technologies for $175m

Wall Street Journal

Monday, 4 March 2013

Revenues fall at Codexis

Codexis reported a 29% fall in revenues in 2012 to $88.3m, which it attributed primarily to the termination of its research agreement with Shell. Additionally, product revenues fell 27% to $35.9m primarily due to the timing of orders from innovator pharmaceutical customers. Codexis said it expects to generate royalty revenues and receive a milestone payment in 2013 from its support of the development of argatroban injection for Exela Pharma Sciences partnership with Hikma Pharmaceuticals.
Seeking Alpha

The US FDA has issues a warning letter Jubilant HollisterStier for violation of cGMP practices at its Kirkland, Quebec, Canada, facility

Hindu Business Line

Genmab finally sells facility

Genmab will sell its non-plasma-derived antibody manufacturing facility, in Brooklyn Park, MN, to Baxter Healthcare for $10m. Baxter will also offer employment to Genmab's employees at the site. Genmab has been trying to sell the facility for a number of years and had written off the value to zero.

Construction has not yet started on the construction of Lonza's Ketlaphela joint venture facility in South Africa due to issues with funding and competitiveness

In-pharma Technologist

Viropro will manufacture six monoclonal antibody products being developed by Oncobiologics

Pharmaceutical Business Review

Evonik's owners have revived plans to list the company in an IPO


Wednesday, 20 February 2013

Lonza will generate induced pluripotent stem cells for research purposes for the US National Institutes of Health Center for Regenerative Medicine at its Walkersville, MD, facility


DSM pharma sales rise in 2012

DSM reported full year 2012 sales rising 9% to €726m, which the company attributed to increased volumes at DSM Pharmaceutical Products. DSM expects the business conditions for the pharma sector to remain challenging in 2013 but is confident of being able to deliver substantially better results during the year.

Thursday, 14 February 2013

Cambrex will manufacture hydroxypropyl methylcellulose acetate succinate for Dow Chemical for use in drug solubility enhancement


AMRI will use enzymes developed by Codexis to develop cheaper routes to manufacture APIs and intermediates

Pharmaceutical Business Review

Mixed manufacturing results at AMRI

AMRI reported development/small scale manufacturing revenues for 2012 were $35.7m, essentially flat with 2011. However, revenues for the large scale m rose 22% to $116.4m. Michael Nolan, AMRI's Vice President, Chief Financial Officer and Treasurer, said the company expects development and small scale revenues to rise up to 7% in 2013 and large scale revenue to rise up to 14%.
Seeking Alpha

Ash Stevens' expansion almost complete

Ash Stevens has completed construction on the expansion of its cGMP manufacturing facility in Riverview, MI, and expects to complete commissioning and validation by April. The new large-scale reactor bay houses 2000, 3000 and 4000L glass-lined vessels and an new isolation bay is equipped with a 1.5m2 fixed filter dryer.
Pharmaceutical Outsourcing

Tuesday, 5 February 2013

Lonza starts to restructure

Lonza will combine its custom manufacturing and bioscience business units into a pharma market segments group. The microbial control and life science ingredients businesses will be regrouped into a specialty ingredients market segments group. The company has also restructured its renamed Executive Committee. The committee will and will consist of five members: Richard Ridinger - CEO, Toralf Haag - CFO, Marc Funk - CLO, Stephan Kutzer - COO and Beat In-Albon - COO.
In-pharma Technologist

FDA leaders are considering a scorecard for quality of manufacturing facilities

Regulatory Focus

Bend Research's Oregon facility has received certification of compliance with European Union GMP regulations by Sweden’s Medical Products Agency

Bend Research

Johnson Matthey reported sales of £63m for its fine chemicals division in Q3

Johnson Matthey

Ben Venue restrained from manufacturing

Boehringer Ingelheim's Ben Venue Laboratories Bedford, Ohio, facility will no be able to manufacture and distribute drugs until the FDA determines that its operations are compliant with the Federal Food, Drug, and Cosmetic Act.
Thomson Reuters

Girindus America's Reading, OH, facility has been acquired Nitto Denko Avecia for $9.5m as part of the previously announced acquisition

Cincinnati Business Courier

Tuesday, 29 January 2013

Cytovance to expand mammalian production

Cytovance Biologics will expand its current mammalian production capabilities in Oklahoma City, OK. The company plans to add a 1000L and 5000L bioreactors and an automated fill/finish line, which are due to be operational by the end of 2013 or early in 2014.

Manufacturing starts at Lonza Houston

Lonza has completed the validation of its new viral-induced cell processing GMP suites in Houston, TX, and has also completed the tech transfer process for a new virally-transfected T-cell product. Lonza said these new cell processing suites will allow it to develop virally-modified autologous cellular immunotherapies.

US seeks EU API import exemption

The US FDA has formally requested to be listed as a third country with GMP rules equivalent to those in the EU to meet the EU's strengthened rules for import of APIs. The FDA said that if its listing request is approved then US exporters will avoid duplicative administrative efforts, which could impede trade and delay the manufacture of needed medicines.
In-pharma Technologist

Angel needs second partnership

Angel Biotechnology needs to sign a second partnership similar to the one it is currently negotiating with NPF Materia Medica Holding to effectively address the company's current trading difficulties. The company said that if both deals were not completed it risks running out of cash by the end of March.
Stockmarket Wire

Thursday, 24 January 2013

Challenging year for Lonza custom manufacturing

Following it acquisition of Arch in 2012, Lonza has reported full year sales of CHF3.93bn. The company reported that sales in custom manufacturing rose 1.5% to CHF1.3bn but Lonza CEO Richard Ridinger said he was unsatisfied with the EBIT performance for the division. The company said it has more than 350 products in its chemical manufacturing pipeline and utilisation was above 75%, close to the 78% reported for 2011. For biologics the company has 340 active projects and capacity utilisation above 70%, down from 87% last year before the Singapore facility opened. Ridinger said that he will complete his review business soon and it may lead to disposals and management changes as he forecast lower-than-expected 2013 earnings.

Wednesday, 23 January 2013

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


Monday, 21 January 2013

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.

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


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

Thursday, 10 January 2013

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