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

Wednesday, 9 January 2013

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


Monday, 7 January 2013

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


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

Wednesday, 2 January 2013

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