Facilities

Pieris teams with Strides Arcolab to develop Anticalin-based drugs

18-Dec-2013 By Dan Stanton

Pieris has selected Stelis Biopharma to develop and manufacture its proprietary Anticalin-based protein therapeutics.

US Gov: Is UN chemical weapons treaty bad for biopharma business?

13-Dec-2013 By Gareth Macdonald

The US Government asked biopharmaceutical companies if the international treaty banning chemical weapons is hampering legitimate business.

Biocon: Course will make Indian graduates 'more employable' in biopharma

13-Dec-2013 By Dan Stanton

Biocon and a Californian institute have formed an academy to develop local talent in India’s biopharma sector.

Shire halts construction of Cali regenerative medicine plant

11-Dec-2013 By Dan Stanton

Shire has stopped construction on its Californian regenerative medicine site citing adequate capacity in its existing facilities.

Alvotech's $250m Icelandic plant will use disposable tech for mAb biosimilars

11-Dec-2013 By Dan Stanton

Alvogen has branched into biomanufacturing with plans to build a $250m (€182m) facility in Iceland to produce biosimilar monoclonal antibodies. 

Pfizer wants more biopharma CMO work and would manufacture for Big Pharma rivals

04-Dec-2013 By Gareth Macdonald

The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals. 

Puerto Rico to 'opportunistically pursue' biologics to regenerate industry

04-Dec-2013 By Dan Stanton

The Puerto Rican Government has laid down plans to regenerate its drug manufacturing industry by pursuing opportunities in biologics.

Cobra says the right tech strategy can cut lead times

02-Dec-2013 By Gareth Macdonald

Choosing the same biomanufacturing tech supplier for development and commercial systems cuts scale steps and reduces lead times according to Cobra Biologics.

Biocon and Mylan's Herceptin biosimilar approved in india

02-Dec-2013 By Dan Stanton

The Drug Controller General of India has approved a biosimilar version of Roche’s Herceptin developed by Biocon and Mylan.

Largest biologics plant in world set as Roche U-turns over biosimilar fizzle

13-Nov-2013 By Dan Stanton

Genentech has recommissioned plans to make a Californian facility the largest biologics plant worldwide after anticipated revenue drop from biosimilars did not materialise.

Orgenesis and ATMI partner in diabetes cell therapy Belgian subsidiary

08-Nov-2013 By Dan Stanton

Orgenesis has partnered ATMI and established a subsidiary in Belgium in order to manufacture cells for clinical trials of its insulin-producing regenerative drug.

ADC Therapeutics licenses proprietary antibodies from Five Prime

08-Nov-2013 By Zachary Brennan

ADC Therapeutics and Five Prime Therapeutics have announced an exclusive license agreement for human antibodies directed to an undisclosed target expressed on the surface of various types of cancers.

Pfenex selects Paragon for HHS anthrax vaccine manufacture

06-Nov-2013 By Dan Stanton

Pfenex has selected Paragon Bioservices to manufacture its Recombinant Protective Antigen (rPA) for an anthrax vaccine as it enters Phase I clinical trials.

Repligen ups disposable chromatography column capacity

06-Nov-2013 By Zachary Brennan

US biopharma company Repligen has completed a 9,000 square foot expansion of its facilities in Massachusetts to meet growing customer demand for disposable chromatography columns and warehousing.

DSM's cGMP biologics plant a boon to Australian biotech, firm says

30-Oct-2013 By Dan Stanton

DSM says its new biomanufacturing facility will benefit the Australian biotech sector, overcoming the problems of distance with foreign contract manufacturers.

Dispatches from CPhI

'The sexiness of the ADC world' - CMOs talk antibody-drug hybrids at CPhI

30-Oct-2013 By Dan Stanton

Piramal’s COO Vijay Shah described antibody-drug conjugates (ADCs) as “a concept whose time has come” at the CPhI annual report press conference and recent investors in the technology echo his words.

Pall opens Centre of Excellence in Shanghai

25-Oct-2013 By Dan Stanton

Pall has opened of a Centre of Excellence (CofE) in Shanghai for both local and international customers.

OncoMed wins first US patent for mAb discovery tech

23-Oct-2013 By Zachary Brennan

OncoMed Pharmaceuticals announced last week that the US Patent and Trademark Office granted its first US patent for technology to identify mAbs (monoclonal antibodies). 

Big Pharma business opportunities driving ADC boom say experts

18-Oct-2013 By Gareth Macdonald

Big Pharma interest in antibody drug conjugates (ADC) hit another high this week with Roche  ,Novartis and AstraZeneca each announcing investments that boost their ability to develop and manufacture these small-molecule monoclonal antibody (mAb) drug...

Securing sterility leads to union headache for Genzyme

18-Oct-2013

Attempting to ensure cleanroom sterility has gotten Genzyme into hot water with Trade Unions who protested outside a Fabrazyme manufacturing plant yesterday.

GSK waiting to ramp up malaria vaccine manufacturing despite Ph III progress

18-Oct-2013 By Zachary Brennan

GlaxSmithKline will wait to ramp up manufacturing capacity of its promising malaria vaccine until after it makes its way through the regulatory process.

Update

Regeneron expands NY, Ireland manufacturing sites as potential mAb shows early success

18-Oct-2013 By Zachary Brennan

Biotech developer Regeneron is investing as much as $300m in its New York manufacturing plants and for a new site in Ireland as part of preparations for a potential new blockbuster monoclonal antibody that treats high cholesterol.

UPDATE

Genzyme to strengthen Fabrazyme production with $80m downstream plant

16-Oct-2013 By Dan Stanton

Genzyme says it will invest $80m (€59m) in a new downstream plant to process its Fabry Disease drug, Fabrazyme.

CMOs invest in fill/finish capacity in response to biopharma demand

11-Oct-2013 By Dan Stanton

Increasing interest in biopharmaceuticals has led to significant CMO investments and upgrades with Recipharm, Vetter and Aesica upping their fill/finish game this week.

Carbogen Amcis CEO: Competition in ADC sector not a concern

04-Oct-2013 By Gareth Macdonald

Investing in antibody-drug conjugates (ADCs) made sense despite CMO competition and the fact few of these hybrid drugs have been approved to date says Carbogen Amcis CEO, Mark Griffiths.

US flu vaccine manufacturing network looks to increase capacity by 20%

04-Oct-2013 By Zachary Brennan

The US Department of Health and Human Services has awarded almost $40m (29m Euros) in contracts to four contract flu vaccine manufacturers as part of an effort to increase fill and finish capacity by 20%.

Carbogen Amcis invests in ADC capacity

02-Oct-2013

Carbogen Amcis AG has become the latest CMO to invest in antibody drug conjugate (ADC) production.

Gallus doubles biologics capacity with acquisition of CMO Laureate

02-Oct-2013 By Dan Stanton

Gallus Biopharmaceuticals has doubled its biologics process development services with the acquisition of contract manufacturer Laureate.

Fujifilm Diosynth Biotechnologies opts for Xcellerex tech at new UK plant

02-Oct-2013 By Gareth Macdonald

Fujifilm Diosynth Biotechnologies has opened a mammalian cell culture-based manufacturing facility in the UK in the latest stage of an effort to expand its business.

GE to build disposable biopharmaceutical factory for JHL Biotech in China

27-Sep-2013 By Zachary Brennan

GE Healthcare Life Sciences has agreed to build a modular biopharmaceutical factory in China for JHL Biotech, which could be a model for ways to grow local manufacturing in emerging markets. 

Kemwell opens doors to West with first mAb deal from Indian plant

25-Sep-2013 By Dan Stanton

Kemwell says it intends to open the Indian market to contract biomanufacturing as it signs its first monoclonal antibody (mAb) development and manufacture agreement for a European biopharma. 

Agilent splits up to create two separate businesses

20-Sep-2013

Agilent Technologies has officially separated its biopharma service offerings from its electric measurement group to create two separate companies, the life science portion of which is expected to bring in about $3.9B in FY2013.

EMD Millipore: New chromatography offerings will meet industry need

20-Sep-2013 By Zachary Brennan

EMD Millipore on Tuesday launched a new protein A chromatography media to help biopharma manufacturers purify monoclonal antibodies, as well as new prepacked chromatography columns.

US Flu Vaccine Manufacturers: Not Enough Quadrivalent Vax Supply

13-Sep-2013 By Zachary Brennan

The US FDA approval of the new quadrivalent flu vaccine in June has not quite given manufacturers enough time to meet demand expectations, as production time can take up to about six months.

Bioreliance Doubles Viral Clearance Space at Maryland Site

11-Sep-2013 By Dan Stanton

Bioreliance has doubled the space for clients to conduct their downstream bioprocessing studies with the opening of its new US Clearance Services Laboratories in Rockville, Maryland.

Report: Biopharma Industry’s Growth Driven By mAb Development

11-Sep-2013 By Zachary Brennan

The $165bn biopharma market is expected to grow by about 15% annually, driven largely by increasing revenue growth from recombinant monoclonal antibodies (mAbs), according to a recent report.

Mitsubishi Closer to Buying Vax and Biosimilar Tech Developer Medicago

30-Aug-2013 By Gareth Macdonald

Mitsubishi Tanabe Pharma (MTPC) is closer to adding two plant-based expression techs to its manufacturing arsenal after Medicago shareholders back its takeover bid. 

UK Biomanufacturing Hub Will Help Firms Cut Costs says CPI

23-Aug-2013 By Gareth Macdonald

The new UK biomanufacturing hub will help BioPharmas cut costs and let those developing novel biodrugs assess manufacturability according to the Centre for Process Innovation (CPI).

Shift to Biomanufacturing Offsetting Ireland's Small Molecule Woes

23-Aug-2013 By Dan Stanton

Biomanufacturing is offsetting a decline in Ireland's small molecule industry caused by the patent cliff and cheaper manufacturing options in the East say industry groups.

NanoViricides Builds Plant to Prep for 'Viral Penicillin' Pipeline

21-Aug-2013 By Dan Stanton

NanoViricides has begun construction of a new GMP sterile manufacturing facility to support approaching human trials in its anti-viral drug pipeline.

Vindon: Biomanufacturers Less Inclined to Outsource Storage Solutions

16-Aug-2013 By Dan Stanton

A trend to outsource storage solutions is being driven by a need to cut costs, says Vindon, though uptake amongst biomanufacturers trails that of small molecule manufacturers.

Manufacturing Concerns Halt US Approval for Novo Nordisk's Factor XIII

14-Aug-2013 By Dan Stanton

Novo Nordisk says it has received a complete response letter for its recombinant factor XIII drug citing manufacturing concerns at a Danish facility.

Regeneron to Add 2 New Bioreactors in NY Plant Expansion

14-Aug-2013

Regeneron will add two new 10,000-litre bioreactors at its East Greenbush facility as part of an $80m expansion.

Uptake in Single-Use is Changing Facility Design, Experts Say

14-Aug-2013 By Dan Stanton

Adapting stainless steel facilities to incorporate increased use of disposable technology can help reduce costs and improve quality compliance, say TFS and Lonza.

Best Way to Ensure Biomanufacturing Plants Have Quality? By Design

09-Aug-2013 By Dan Stanton

Regulatory compliance, simplicity and flexibility are the key things to remember when designing a biomanufacturing facility says Lonza, M+W and TFS.

Thermo Fisher Opens First Dry Powder Media Plant in Singapore

07-Aug-2013 By Dan Stanton

Growing demand amongst biomanufacturers has prompted Thermo Fisher to open the first dry powder media (DPM) production plant in Singapore.

Piramal Invests $2.5m to Expand ADC Capacity in Scotland

02-Aug-2013 By Zachary Brennan

Piramal is upgrading its ADC (antibody drug conjugate) manufacturing capacity in response to demand from clients in late phase trials looking to ramp up production.

Samsung Biologics in 10 Year Deal to Make Yervoy MAb for BMS

31-Jul-2013 By Dan Stanton

Bristol-Myers Squibb has selected Samsung Biologics to manufacture the antibody cancer drug Yervoy for markets outside the US.

'First Japanese Clinical Trial using Stem Cells’ isn’t and doesn't say Researchers

31-Jul-2013 By Gareth Macdonald

Recent reports of a 'clinical trial' assessing 'stem cells' for the treatment of AMD are wrong say the Japanese researchers trying to transform somatic cells into retinal pigment epithelium (RPE) cells for transplant.

Regeneron Plans Ireland MAb Plant if Dell Deal Completes

24-Jul-2013 By Gareth Macdonald

Regeneron plans to turn a former computer plant in Ireland into a biologics manufacturing hub to boost MAb production capacity.