Bio-Outsourcing

Mundipharma associate launches Remsima in UK and preps for wider roll out

25-Feb-2015 By Gareth Macdonald

Mundipharma’s associate Napp Pharmaceuticals launched Celltrion’s Remicade biosimilar Remisma in the UK today, just 24 hours after the originator lost patent protection.

UK gives $31m to industry-academic biodevelopment collabs

25-Feb-2015 By Fiona BARRY

The UK has granted £20m ($31m) to the biotech industry – including Horizon, FujiFilm, and Cobra Biologics, to bring mAb, cell expression, and antibiotic projects to market.

Celltrion explains two-brand Remicade biosimilar strategy

24-Feb-2015 By Gareth Macdonald

Celltrion says the two-brand strategy for its Remicade biosimilar will help it cater for local needs and cultural differences.

Cynata validates stem cell manufacturing process at Wisconsin biomanufacturing site

24-Feb-2015 By Zachary Brennan

Australian stem cell and regenerative medicine company Cynata Therapeutics is now set to scale up manufacturing of its mesenchymal stem cells (MSCs) for therapeutic use.

IDRI receives $4m from BARDA to create adjuvant manufacturing hub

20-Feb-2015 By Zachary Brennan

Seattle-based Infectious Disease Research Institute (IDRI) has received $4m in funding from the US Biomedical Advanced Research and Development Authority (BARDA) to develop an adjuvant manufacturing hub with both preclinical and clinical expertise to...

Sanofi: deals like Lead Pharma accord not a replacement for in-house R&D

18-Feb-2015 By Gareth Macdonald

Sanofi has partnered with Dutch biotechnology spin-out Lead Pharma to discover autoimmune drugs that target ROR gamma t hormone receptors.

Novasep signs €4.7m biomanufacturing deal with biotech

18-Feb-2015 By Zachary Brennan

Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.

EMA defends Humira redactions, says only commercial info was blacked out

10-Feb-2015 By Gareth Macdonald

The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’

Boehringer and VTU extend yeast-based expression system tech deal

10-Feb-2015 By Dan Stanton

Boehringer-Ingelheim has renewed its collaboration with VTU technology to develop a yeast-based protein expression system for biopharmaceutical production.

Juno Therapeutics adds new biomanufacturing facility in Washington, will continue using CMOs

10-Feb-2015 By Zachary Brennan

Cell-based cancer immunotherapy company Juno Therapeutics has entered into a lease agreement for a manufacturing facility in Bothell, Washington to produce its developing cell therapies.

US dollar prompts ThermoFisher to predict flat revs in 2015 and move reagents to Lithuania

30-Jan-2015 By Gareth Macdonald

ThermoFisher has forecast flat sales and earnings in 2015, warning that weaker currencies in key markets will offset higher biopharma spending.

Valeant eyes up personalised meds market with $300m Provenge bid

30-Jan-2015 By Dan Stanton

Valeant is set to buy Dendreon’s prostate cancer drug Provenge as an economic way to enter the personalised oncology market.

Sartorius: US fully embracing single-use as bioprocess unit leads 13% growth

29-Jan-2015 By Dan Stanton

The US has caught up with Europe in adopting single-use technologies, says Sartorius which reported a 32% growth in sales for the region in 2014.

Biosimilar mAbs may have tougher time winning US FDA approval says expert

21-Jan-2015 By Gareth Macdonald

So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles than in Europe.

Teva: More biomanufacturing space needed to tap biologics opportunities

21-Jan-2015 By Dan Stanton

Teva must invest in its biomanufacturing network as the firm’s biologics aspirations grow beyond biosimilars, CEO Erez Vigodman told investors.

Antitope to produce manufacturing cell lines for two potential HIV vaccines

21-Jan-2015 By Zachary Brennan

Abenza subsidiary Antitope has extended its relationship and will provide manufacturing cell lines for two developing HIV vaccines from the French National Institute of Health and Medical Research (INSERM); the National Health Agency for Research on AIDS...

Catalent and Mitsubishi GC team up for Asian cell line offering

20-Jan-2015 By Fiona BARRY

Catalent is taking aim at the Asian market with a partnership with Mitsubishi Gas Chemical Company to make cell lines for the region.

Novozymes predicts half-life boost for pharma business, but lets long term rev forecast slide on oil prices

20-Jan-2015 By Gareth Macdonald

Novozymes finished 2014 with higher pharma revenues thanks in part to GSK's adoption of its albumin half-life extension technology, Veltis.

Piramal acquires Kentucky-based CDMO for $30m

20-Jan-2015 By Zachary Brennan

India-based CMO Piramal has acquired US-based sterile injectable CDMO (contract development and manufacturing organization) Coldstream Laboratories for $30.65m.

Sanofi selects B-I to manufacture growing monoclonal antibody portfolio

16-Jan-2015 By Dan Stanton

Sanofi has selected Boehringer-Ingelheim to manufacture monoclonal antibodies in an agreement that extends to the French drugmaker's partner Regeneron.

Lonza's biopharma focus intensified towards end of 2014

14-Jan-2015 By Gareth Macdonald

Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.

NeoStem, Invetech to develop closed processing system for cell therapy manufacturing

14-Jan-2015 By Zachary Brennan

Cell therapy manufacturer NeoStem and contract manufacturer Invetech have agreed to develop a new closed processing system for cell therapy manufacturing. 

Cellectis patent surprises biopharma, could block CRISPR

09-Jan-2015 By Fiona Barry

A patent issued to French biotech Cellectis threatens to block gene editing tools currently in use by several big pharma and service companies.

Sotio selects Czech CRO for personalised dendritic cell vaccine trial

07-Jan-2015 By Dan Stanton

Sotio has selected local CRO Accord Research to carry out Phase I/II trials on its dendritic cell vaccines to treat patients with lung cancer in the Czech Republic.

Pfizer buys herpes vaccine, access to orphan growth hormone

07-Jan-2015 By Fiona Barry

Pfizer has acquired a herpes vaccine candidate with the buyout of Swiss preclinical-stage company Redvax.

Protein Sciences turns to Japan for manufacturing Flublok for Asia

06-Jan-2015 By Zachary Brennan

Flu vaccine maker Protein Sciences, and Japan-based UMN Pharma and IHI Corp. have entered into an agreement to assess the feasibility of sourcing the active ingredients of Flublok influenza vaccine from Japan.  

Harvard, Korean scientists develop new material to help deliver 3D vaccines

19-Dec-2014 By Zachary Brennan

Korean and Harvard University scientists have developed a way to non–surgically inject programmable biomaterial to deliver a 3D vaccine that can more effectively treat diseases like cancer or HIV.

Biocon planning new biomanufacturing plant in India

17-Dec-2014 By Dan Stanton

Indian drugmaker and biosimilars pioneer Biocon has told the Chief Minister of Andhra Pradesh it intends to set up a new biomanufacturing plant.

Singapore develops plan to support influx of biomanufacturing

16-Dec-2014 By Zachary Brennan

Industry heavyweights and Singaporean development groups have unveiled a five-year roadmap to deal with the need for more employees in the fast-growing biologics manufacturing industry on the island.

'Off the shelf' stem cell firm to benefit from in-house facility, says analyst

12-Dec-2014 By Dan Stanton

Analyst firm N+1Singer has endorsed stem cell manufacturer Reneuron based on its “off-the-shelf” therapy pipeline and a new facility that will reduce the need to outsource.

Peregrine expanding own CMO to make mAb candidate rather than outsource

11-Dec-2014 By Dan Stanton

Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.

Report: Increased dealmaking will launch stem cell therapies within 5 years

11-Dec-2014 By Dan Stanton

Stem cell therapies are on the brink of breaking through into the mainstream drug market, according to a GlobalData report, despite having been hindered by a lack of R&D funding.

Horizon Discovery enters crowded CHO cell line market

09-Dec-2014 By Zachary Brennan

Horizon Discovery Group announced Monday that its bioproduction division has shipped its first commercially available engineered CHO (Chinese Hamster Ovary) cell line for use in manufacturing of antibodies. 

GE Healthcare licenses CRISPR gene-snipping tool from Broad Institute

05-Dec-2014 By Fiona Barry

GE Healthcare is the latest company to adopt the CRISPR-Cas9 gene editing technology through a deal with the Broad Institute. 

Catalent contracted to manufacture Valerion's orphan drug candidates

03-Dec-2014 By Dan Stanton

Valerion Therapeutics has inked an agreement for the manufacture of two orphan drug candidates using Catalent’s GPEx mammalian cell line platform.

Ranbaxy launches India’s first Remicade biosimilar

03-Dec-2014 By Zachary Brennan

Ranbaxy Laboratories has launched the monoclonal antibody Infimab, the first Remicade (Infliximab) biosimilar, in India -- which is the first what could be a few home-grown biosimilar launches.  

CMO use to grow despite Big Biopharma's in-house spend, say experts

02-Dec-2014 By Dan Stanton

Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”

UPDATE

AstraZeneca injects $200m into Maryland plant to support biologics pipeline

25-Nov-2014 By Dan Stanton

AstraZeneca is investing over $200m (€160m) at a facility in Maryland to support its pipeline of over 120 biologics, the company says.

AbbVie buys small molecule API plant to support ADC manufacture in Singapore

25-Nov-2014 By Dan Stanton

An API facility in Singapore acquired by AbbVie on the site where it is building a $320m biologics plant will support the firm's antibody-drug conjugate (ADC) pipeline.

Merck to manufacture NewLink Ebola vaccine in-house

25-Nov-2014 By Zachary Brennan

Merck has agreed to research, develop, manufacture, and distribute NewLink’s investigational Ebola vaccine candidate, which is currently in Phase I trials.

Agilent: Biologics growth presents biggest consumables opportunity

21-Nov-2014 By Dan Stanton

The growth in biologics has given Agilent Technologies a “huge opportunity for services and consumables,” according to the firm’s CEO-Elect.

Novartis to keep complex biologics manufacturing in-house

21-Nov-2014 By Dan Stanton

Novartis says it will keep biomanufacturing in-house and outsource more production of its small molecule portfolio in a strategy mirroring its Big Pharma peers.

Research institute wins $11.9m NIH contract to make thermostable TB vaccine

21-Nov-2014 By Zachary Brennan

With the goal of developing a thermostable tuberculosis vaccine, IDRI (Infectious Disease Research Institute) was awarded a contract from the NIH’s National Institute of Allergy and Infectious Diseases that could be worth up to $11.9m.

Questions raised over new $2.6bn price tag to bring a new drug to market

19-Nov-2014 By Zachary Brennan

The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.

Collaboration can fix ‘broken’ clinical trials model TransCelerate CEO tells CROs

18-Nov-2014 By Gareth Macdonald

Collaboration does not mean drugmakers have started playing nice, it’s just that the pain of shared problems has become unbearable according to TransCelerate Biopharma CEO, Dalvir Gill.

Needles no more: say hello to a tube of squeezable biologics

18-Nov-2014 By Fiona Barry

Drug companies are looking for ways to put biologics in topical creams or “zap” them into skin using electricity as more large molecules come off patent.

GE sets up in Istanbul in bid to capture a share of Turkish tech market

14-Nov-2014 By Gareth Macdonald

Turkey’s efforts to increase local biopharmaceutical production have prompted GE Healthcare Life Sciences to set up a biopharmaceutical technology training centre in Istanbul.

VWR steps into world of single-use with two acquisitions

11-Nov-2014 By Zachary Brennan

Lab service provider VWR is moving into the industry of single-use bioprocessing with the acquisitions of Integra Companies and STI Components.

Anyone seen China’s draft biosimilars guidelines? Apparently there are some

07-Nov-2014 By Gareth Macdonald

Biosimilar developers targeting China have just three weeks to first find and then comment on draft guidelines released by the CFDA.

Amgen files FDA petition, lawsuit seeking info on Sandoz biosimilar manufacturing

07-Nov-2014 By Zachary Brennan

The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.