Facilities

Irvine Scientific looks to tap CAR-T growth with new media

21-Jan-2015 By Zachary Brennan

Cell culture media manufacturer Irvine Scientific has launched a new xeno-free and serum-free medium that supports immunotherapy production.

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.

Argos looks to disposables for manufacturing personalized immunotherapies

07-Jan-2015 By Zachary Brennan

Cancer and infectious disease immunotherapy developer Argos Therapeutics is collaborating with Saint-Gobain’s Performance Plastics division, to design, integrate and scale production of a range of disposables for use in the manufacturing of Argos’ lead...

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.

Rouble trouble: Big Pharma exposure to Russian currency volatility limited

17-Dec-2014 By Gareth Macdonald

Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.

Immunotherapy in the UK? National manufacturing site backed by GE

17-Dec-2014 By Dan Stanton

GE Healthcare has pledged its support and technology to a national £55m ($86m) Cell Therapy manufacturing centre in Stevenage, UK, set to launch in 2017.

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.

$A dry fracture of a Vero cell exposing the contents of a vacuole where Coxiella burnetii (the Bacteria that cause Q Fever) are growing$

Baxter exits vaccines business as it preps for biopharma spinout

16-Dec-2014 By Dan Stanton

Baxter has sold its pandemic flu portfolio and Vero cell technology to Nanotherapeutics in preparation for the launch of its haematology and oncology-based spinout company Baxalta.

AstraZeneca shutting asthma drug plant as pipeline shifts to biologics

12-Dec-2014 By Dan Stanton

AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.

'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.

Reports of Pierre Fabre's pharma death greatly exaggerated? Cancer mAb R&D to continue

11-Dec-2014 By Gareth Macdonald

Pierre Fabre has spared its biopharmaceutical research team from job cuts unveiled last night, signalling that high value biologics will be a focus for its reduced pharma R&D activities.

Want to work for Pfizer? Get ready for ‘American Idol’ audition

10-Dec-2014 By Fiona Barry

Pfizer has revealed a unique way of hiring employees in Sweden it compares to “American Idol” auditions.

US government offers legal immunity to Ebola vaccine manufacturers, CMOs

10-Dec-2014 By Zachary Brennan

Manufacturers developing Ebola vaccines will be immune from lawsuits following a decision by US HHS (Health and Human Services) to issue a declaration on the matter.

Flu vaccine underwent 35 QA/QC tests in Italy death probe, says Novartis

05-Dec-2014 By Dan Stanton

Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.

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.

Pall up on single-use and steel hybrid bioprocessing systems

26-Nov-2014 By Dan Stanton

A hybrid of disposable and stainless steel systems will remain the biomanufacturing model for the near future, says Pall reporting a robust first quarter 2015.

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.

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.

Amgen launches $200m biomanufacturing facility in Singapore

21-Nov-2014 By Zachary Brennan

Amgen has completed construction of its first $200m next-gen biomanufacturing facility in Singapore, which is outfitted with single-use technology to allow for greater flexibility.

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.

BMS highlights shift to biologics with plans for $900m plant in Ireland

14-Nov-2014 By Dan Stanton

Bristol-Myers Squibb has announced plans to build a biologics facility in Ireland, eight months after winding down a small molecule API plant at the same site.

WuXi plans commercial biomanufacturing plant on back of biologics demand

14-Nov-2014 By Dan Stanton

WuXi PharmaTech has reported a 23% growth in manufacturing services and is planning to build a commercial biomanufacturing facility to meet the strong demand for biologics.

ViaCyte wins US patent to manufacture human pancreatic progenitor cells

11-Nov-2014 By Zachary Brennan

Regenerative medicine company ViaCyte has been granted a US patent for the manufacture of human pancreatic progenitor cells from definitive endoderm cells.

Repligen invests $4m at MA facility to support ATF acquisition

11-Nov-2014 By Dan Stanton

Repligen has invested $4m (€3.2m) in its Massachusetts manufacturing facility in order to support the fermentation cell retention technology acquired from Refine.

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.

Dispatches from AAPS 2014

GSK ‘moves best people’ to keep Ebola vaccine manufacture in-house

07-Nov-2014 By Fiona Barry

GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.

Vendors' role in single-use plant design could cut costs, says M+W

04-Nov-2014 By Dan Stanton

Single-use vendors could help cut costs in designing and building biopharma facilities, according to engineering firm M+W.

Amgen chases $3bn biosimilar market with three new programs, biomanufacturing capabilities

29-Oct-2014 By Zachary Brennan

Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.

Fujifilm to buy BARDA contractor Kalon Therapeutics

28-Oct-2014 By Gareth Macdonald

Texas, US-based GSK influenza vaccine partner Kalon Therapeutics has agreed to a takeover by Japanese conglomerate Fujifilm.

CSL pays $275m to acquire Novartis’ flu vaccines, three manufacturing sites

28-Oct-2014 By Zachary Brennan

CSL Limited has agreed to acquire Novartis’ flu vaccine business for $275m (€216m), which includes manufacturing facilities in the US, UK and Germany.

Eli Lilly confident in its manufacturing for Insulin biosimilar market share

24-Oct-2014 By Dan Stanton

Eli Lilly’ manufacturing network will give it the edge in the glargine insulin market, the firm says having received tentative approval of its “Lantus look-alike” from the USFDA.

Argos begins construction on new biomanufacturing facility in North Carolina

24-Oct-2014 By Zachary Brennan

Personalized immunotherapy developer Argos Therapeutics has broken ground on a new 100,000 square-foot biomanufacturing facility in Durham, North Carolina.

Single-use vendors play vital role in biopharma supply chain, says Sartorius

22-Oct-2014 By Dan Stanton

Close relationships between vendors and biomanufacturers are critical according to Sartorius, which was been awarded an accolade for the design of WuXi AppTec’s biologics production facility in China.

Correction

Biotherapeutics need general chapters not individual Ph. Eur. monographs says EGA

21-Oct-2014 By Gareth Macdonald

Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.

Amgen studying what impact switching to 'biosimilar' Aranesp has on patients

21-Oct-2014 By Gareth Macdonald

Amgen is reviewing data from chronic kidney disease (CKD) patients to assess what impact switching to a 'biosimilar' version of its blood cell booster Aranesp (Darbepoetin Alfa) has had on their disease.

Future trends: Rise of mAbs and fall of 20,000L bioreactors says consultant

17-Oct-2014 By Dan Stanton

Increased efficiency, local manufacturing and specialty products are driving demand for smaller more flexible facilities, according to bioprocessing consultant Howard Levine.

EC Oks 'dead' Abbvie-Shire takeover deal

17-Oct-2014 By Gareth Macdonald

Great news Abbvie; the European Commission (EC) has no problem with you buying Shire.

Texas A&M licenses Xoma mobile clean room tech citing cost savings and flexibility

10-Oct-2014 By Gareth Macdonald

US academics have licensed a mobile clean room design from Xoma for a vaccine and medical countermeasure plant being built in Texas as part of an HHS-funded project.

Baxter Transitions Biopharma R&D to a New Hub in Cambridge

07-Oct-2014 By Agnes Shanley

Baxter International plans to set up a new global R&D center in Cambridge, Mass, for Baxalta, its biopharmaceuticals spinoff, which is expected be formally incorporated next year and headquartered in northern Illinois.