NEWS AND VIEWS FROM THE PHARMACEUTICAL FINE CHEMICAL AND CUSTOM MANUFACTURING SECTOR

Thursday 30 June 2011

Lonza has instigated 43-hour working at its Visp, Switzerland, facility to offset currency pressures on profitability

Lonza

Prosonix secures funding

Prosonix has raised £11.4m in Series B funding to move its pipeline of proprietary mono and multi-component combination respiratory therapies through phase II clinical trials. Ventech led the round with Gilde Healthcare Partners joining existing investors the Entrepreneurs Fund, Solon Ventures and Quest for Growth. David Hipkiss, Prosonix's CEO said "these new funds will allow us to attain key performance and clinical data for our pipeline of advanced fast-to-market respiratory programs that will deliver significant added value and benefits to patients and payors alike."
In-pharma Technologist

Cambridge Major Laboratories Europe will manufacture cGMP material for use in clinical studies for Summit's preclinical antibiotic candidate

Manufacturing Chemist

Tuesday 28 June 2011

Senator calls on FDA to tighten outsourcing rules

US Senator Sherrod Brown has called on the FDA to tighten its oversight of outsourcing of API production by US pharmaceutical companies. The Senator said: "When drug companies outsource pharmaceutical ingredients, they also outsource drug safety standards. It's simply unacceptable to allow drug companies to skirt existing regulations by importing ingredients from countries with lax safety standards. Drug company profits cannot come at the expense of consumer safety. Pharmaceutical companies must be able to guarantee the safety of their products and trace the origin of their ingredients.”
Sherrod Brown

Bakhu Pharma has completed the purchase of Phoenix Chemicals' Annan, Scotland, site

News & Star

DSM has introduced new downstream processing technology for for faster and more cost effective production of monoclonal antibodies

PR Newswire

Lonza has introduced a new cell culture medium and feed platform for its GS Gene Expression System that achieves product yields up to 10g/L

Lonza

Fujifilm and Mitsubishi enter partnership

Mitsubishi has acquired a 20% stake in Fujifilm's Fujifilm Diosynth Biotechnologies US and UK business units. Following the deal Mitsubishi and Fujifilm will jointly mange the two business units "to strongly promote the expansion of the biopharmaceutical contract manufacturing business". Fujifilm completed the acquisition of the business from Merck in April.
Fujifilm Diosynth Biologics

Monday 27 June 2011

CMC expansion almost complete

CMC Biologics has almost completed the expansion of its biomanufacturing production facility in Bothell, WA. The expansion will add a 3000L bioreactor train to increase commercial manufacturing.
Pharmaceutical Business Review

Lonza has launched a service to offer early stage development and manufacturing of novel biologics

Lonza

Lonza has received the $260,000 payment it was owed by Regenicin

North Jersey

CABB acquires KemFine

CABB has paid €140m to acquire KemFine from 3i. KemFine, which is headquartered in Helsinki and operates a production facility in Kokkola, Finland, had sales of €81m in 2010. Uwe Kolb, partner responsible for CABB's investors Bridgepoint’s investment activities in the German speaking countries, said: "KemFine is a good fit with our recent acquisition of CABB where our aim is to drive further growth through investments in new technology and new capacities, regional expansion projects and further bolt-on acquisitions.”
Bloomberg

Siegfried plan to power its Pennsville, NJ, facility with solar power

NJ.com

Boehringer Ingelheim is expanding its biopharmaceutical fill and finish capabilities in Biberach, Germany

Boehringer Ingelheim

Tuesday 21 June 2011

FDA plans new approach to drug imports

The FDA has launched a plan to improve the safety of pharmaceutical products being imported into the US. The plan includes partnerships and data sharing with regulators across the world.
Wall Street Journal

Evonik Industries has increased its production capacity for the pharmaceutical amino acid glycine by 50 percent

Pharmaceutical Business Review

RecipharmCobra Biologics will continue to advance KAHR Medical's KAHR-102 for future pre-clinical and clinical testing

Recipharm

Pfizer applies for QbD pilot

Pfizer is the first company to apply for the European Medicines Agency's (EMA) and the US Food and Drug Administration's (FDA) 'quality by design' pilot programme. The programme aims to achieve increased co-operation in drug evaluations between the agencies.
PM Live

Lonza has launched the refinancing of its existing CHF500m revolving credit facility

Lonza

Thursday 16 June 2011

Intercell's cGMP biologics facility in Gaithersberg, MD, is available for lease

Pharma BioSource Realty

Dishman shifts focus

Dishman Pharmaceuticals and Chemicals Ltd is planning to shift its focus from low-margin to high-margin products in a bid to boost profits. The company is also re-structuring its Carbogen Amcis subsidiary to bring it back on a growth track.
Business Standard

Thursday 9 June 2011

Pfenex to develop processes for SAFC

Pfenex will engineer production strains and processes for SAFC’s contract manufacturing customers. The developed processes will ultimately be transferred to SAFC’s recently expanded fermentation facility in Jerusalem, Israel for cGMP production. The companies will also work together to combine Pfenex’s Reagent Proteins product offerings in the area of vaccine components with SAFC’s expertise and facilities for bioconjugation to support development of conjugate vaccines.
Contract Pharma

Lonza expands in Singapore

Lonza will expand its biopharmaceutical development services platform in Singapore. the CHF10m investment will add 1858m2 of state-of-the-art laboratory space and associated equipment. The additional facilities will support cell line construction, upstream and downstream process development, and analytical services. Lonza said the new facility will come on-line in H1 2012.
GEN

Wednesday 8 June 2011

Sales fall at Dottikon

Dottikon reported a 30% fall in sales to CHF80.1m for the year ended 31 March 2011 compared to 2010 and a net loss of CHF7.1m compared to income of CHF12.6m the previous year. The company said the main contributor to the sales decline was a 37% fall in sales of pharmaceutical products as a result of several discontinued and delayed customer projects in the late development phase, together with persistent price and currency pressure.
Dottikon

Viropro's Biologics Process Development subsidiary will double the size of its bioprocess and scale-up laboratory in Poway, CA

Viropro

Aesica's facility in Pianezza, Italy, has received accreditation to manufacture and supply non sterile drugs to the Japanese market

Manufacturing Chemist

Laureate Biopharmaceutical Services will manufacture Patrys' lead antibody PAT-LM1 for preclinical and clinical use

Sacramento Bee

Sunday 5 June 2011

Indian API manufacturers are looking for deals in Japan following after Japanese government opens up its pharmaceutical market to generic drugs

Business Standard

Capacity and costs drive outsourcing

A recent survey of the pharma and biopharma community has revealed that 54.% of organisations outsource less than half of their global manufacturing and that 18.2% currently outsource over 90% of their output. Lack of internal capacity and cost savings were the two key reasons for outsourcing.
GPCM

Fujifilm Diosynth Biotechnologies has added a 1,000L Xcellerex Single-Use Bioreactor at its North Carolina facility

Fujifilm Diosynth Biotechnologies

Sales at Onyx Scientific grew 27% to £3.6m in the last year

Technology Networks

Matthey sales grow

Johnson Matthey's fine chemicals business division ended the year to 31 March with revenues up 14% to £255m and sales up 11% to £245m. The company said it saw good sales growth in its API manufacturing businesses and expects that the division will continue to grow steadily in 2011/12 as a result of increasing demand for its APIs, new product introductions and the additional capacity following the acquisition of the Conshohocken, NJ plant 2010.
Johnson Matthey

Boehringer Ingelheim will produce Betaferon for Bayer after Bayer closes its production facility in Emeryville, CA

RTT News