Bio-Outsourcing

BMS's 'industrial evolution' blow to Irish small molecule plant

11-Mar-2014 By Dan Stanton

Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.

DSM to honour Australian biologics plant contract post-Patheon merger

07-Mar-2014 By Dan Stanton

Operations will continue and may even be enhanced at DSM’s Australian taxpayer-funded biologics plant following a merger with Patheon, the Queensland Government says.

Urbane biomanufacturing: Will making biologics in cities become fashionable?

05-Mar-2014 By Gareth Macdonald

The high street of tomorrow is likely to be a mix of supermarkets, banks and biopharmaceutical manufacturing plants according to one expert who says urban drug production has significant advantages for Pharma firms and patients.

Demand for plasmid production growing says Cobra Biologics

04-Mar-2014 By Dan Stanton

Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.

Proteomics teams with inVentiv for biosimilar, biologics development

04-Mar-2014 By Zachary Brennan

Proteomics International has agreed to collaborate with inVentiv Health to develop biosimilars and biologics, which will begin with structural and functional characterization. 

Adcetris to become a blockbuster for ADC biotech Seattle Genetics, says analyst

25-Feb-2014 By Dan Stanton

Seattle Genetics has been upgraded to ‘outperform’ by an analyst based on its antibody-drug conjugate (ADC) technology platforms, pipeline and the potential of Adcetris to become a blockbuster.

MCW to use Transposagen's 'more flexible than ZFN' gene editing tools

19-Feb-2014 By Dan Stanton

Transposagen says its XTN Talen technology is more flexible than Zinc Finger Nuclease (ZFN) platforms for gene editing and creating genetically engineered cell lines.

Expert predicts downstream ‘failures’ will be focus of UK hub

14-Feb-2014 By Fiona Barry

Downstream processing techs are harder to use and the focus of less innovation than systems employed upstream says the team developing the UK's new National Biologics Manufacturing Centre.

MAb biosimilar Inflectra launched in CEE region; Approved in Canada

14-Feb-2014 By Dan Stanton

Inflectra has been launched in Central and Eastern Europe (CEE) and, as the world’s first monoclonal antibody biosimilar drug goes from strength-to-strength, has also been approved by Health Canada.

Cobra attains QC testing accreditation at Swedish plant

12-Feb-2014

Cobra says it will no longer need to rely on third-parties for its biologics quality control tests after receiving an extension to its GMP certification at a Swedish facility.

Pre-emptive state legislation may hinder biosimilar adoption in US

07-Feb-2014 By Zachary Brennan

At least seven states are taking actions that may hinder the substitution of biosimilars for biologics even though the US FDA has yet to approve any.

Demand for biosimilar analysis drives BioOutsource to double capacity

05-Feb-2014 By Dan Stanton

BioOutsource says it has quadrupled its revenue from biologics testing and biosimilar characterisation in the last 18 months and is opening a new facility to cope with continued demand.

Merck & Co. to discover 'smaller antibodies' in potential €1.7bn deal

04-Feb-2014 By Dan Stanton

Biologics could be delivered by routes other than injection using nanobodies one tenth the size of an antibody, Ablynx says as it extends its license with Merck & Co.

Double biologics expansion for CMOs Gallus and Cytovance

31-Jan-2014 By Fiona Barry

Contract manufacturers Cytovance and Gallus have both invested millions of dollars in expanding their biologics-manufacturing facilities.

What’s holding up biosimilars in the US? Researchers investigate

29-Jan-2014 By Zachary Brennan

Politics might not be the only obstacle in getting biosimilars approved in the US, though much of the rest of the world seems intent on obtaining approvals as fast as possible, according to a new report from research company Frost & Sullivan.

Lonza confident manufacturing capacity will be filled, post Teva biosimilar JV

24-Jan-2014 By Dan Stanton

The end of Lonza’s biosimilar joint venture with Teva will not affect manufacturing capacity, the firm says, as it reports a drop in overall revenue for 2013. 

Man-made tracheas move into clinical trial manufacturing phase

22-Jan-2014 By Zachary Brennan

Synthetically engineered tracheas may be marketed sooner than previously thought as a Harvard Bioscience spinoff prepares to produce the “scaffolds” for growing tracheas in more clinical trials.

NewCo to get DSM Biologics and Australian plant says Royal DSM

21-Jan-2014 By Gareth Macdonald

Royal DSM has confirmed that its biologics manufacturing operations and new Australian facility will be part of the business merged with Patheon in its agreement with JLL.

Wuxi predicts growth for biologics manufacturing in 2014

21-Jan-2014 By Zachary Brennan

WuXi PharmaTech has predicted that demand for its biopharmaceutical manufacturing services will increase this year just days after upping its guidance for fiscal 2013.

ADCs are so 2013 as Immunogen and CytomX team up on PDCs

17-Jan-2014 By Dan Stanton

Immunogen has inked a deal to use probodies from CytomX with its own cytotoxics and linker technology, to create probody-drug conjugates (PDCs).

Celltrion receives S Korean approval for biosimilar of Roche's cancer drug

15-Jan-2014 By Dan Stanton

South Korea has approved a version of Roche’s monoclonal antibody drug Herceptin developed by Hospira’s biosimilar partner Celltrion.

Index Ventures selects Lonza for exclusive 5-year biologics contract

10-Jan-2014 By Dan Stanton

Lonza has signed a five year deal to provide exclusive biologics development and manufacturing services for biotech firms within Index Ventures portfolio.

Sanofi undertakes CMO work for Isarna

10-Jan-2014 By Fiona Barry

Sanofi has agreed to manufacture antisense oligonucleotides (ASOs) for German firm Isarna Therapeutics GmbH.

Hospira: Biosimilar JV unaffected if Celltrion is sold

10-Jan-2014 By Dan Stanton

Hospira says its biosimilar partnership with Celltrion is secure even if the South Korean manufacturer is acquired as several media reports have speculated.

AstraZeneca licenses Immunocore's T-Cell platform for potential $300m

08-Jan-2014 By Dan Stanton

AstraZeneca has become the third Big Biopharma to strike a deal with Immunocore to license its Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology.

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.

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.

Smaller large molecules? Roche invests $62m in DARPin dev deal

11-Dec-2013 By Dan Stanton

Roche has teamed with Molecular Profiles to test if short protein sequences can be used to target conjugated cancer drugs when antibodies prove to large.

Therapure acquires chromatography tech in Upfront deal

06-Dec-2013 By Dan Stanton

Technology firm Upfront Chromatography has exited the biopharmaceutical manufacturing market after selling its protein purification business to Therapure Biopharma.

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. 

Dispatches from AAPS

Almac launches 'unique' radiolabeling service for ADCs; names Pfizer client

02-Dec-2013 By Dan Stanton

Almac says it is in a unique position to offer Carbon-14 ADME radiolabeling for the growing antibody-drug conjugate (ADC) market and has already performed the service on a Pfizer candidate.

Genetically engineered rice proves to produce high yields of rotavirus-specific antibody

29-Nov-2013 By Zachary Brennan

Researchers recently genetically engineered rice to produce high yields of an antibody that proved effective in a study to treat and prevent rotavirus-induced gastrointestinal symptoms in mice.

Analyst says Parexel saw demand from small and mid-sized biopharmas decline in fiscal Q1

22-Nov-2013

Parexel has seen small and mid-sized biopharma demand for development services decline in recent months according to an anaylst who attended the CROs presentation at the Jefferies Global Healthcare conference this week.

Physician oversight and recruitment issues in biosimilar trials, CROs say

15-Nov-2013 By Dan Stanton

Biosimilar clinical trials are increasing but levels of physician oversight and regulatory decisions are still hurdles to overcome, say Parexel, PPD and Vince & Associates.

dispatches from aaps

What does clinically meaningful mean? US lawyer predicts biosimilar battles

13-Nov-2013 By Gareth Macdonald

Unclear terms in US biosimilars laws and the high cost of filing with the Food and Drug Administration (FDA) has set the stage for legal battles according to a lawyer who spoke at AAPS this week.

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.

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.

update

Lack of US FDA biosimilars guidance not holding back global dev say EMA meeting attendees

31-Oct-2013 By Gareth Macdonald

The lack of US FDA biosimilars guidance is not holding back development say BioPharmas and regulators who met with the EMA this week.

DSM selected as second manufacturer of Factor IX mAb

31-Oct-2013 By Dan Stanton

DSM has been selected by Sanquin to be the second manufacturer of its factor IX antibody for its haemophilia drug.

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.

update

Stada to sell Apotex' biosimilar filgrastim in Europe

30-Oct-2013 By Gareth Macdonald

Stada Arzneimittel has licensed European rights to a biosimilar version of the white blood cell booster filgrastim from Apotex and says it is not worried by competitors already in the market.

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.

DISPATCHES FROM CPhI

Cobra Biologics looks to reduce volume waste during fill/finish

23-Oct-2013 By Dan Stanton

A project to minimise the hold-up volume and losses in the fill/finish of biologics has reduced biologic waste ten-fold, says Cobra Biologics.

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.

Bayer extends license of 'workhorse' antibody discovery tech

18-Oct-2013 By Dan Stanton

Bioinvent’s n-CoDeR library has been described as a "workhorse" for antibody discovery by Bayer as it extends and broadens its license agreement.

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.

Good news CMOs: Roche will still outsource after $877m biologics investment

16-Oct-2013 By Gareth Macdonald

Roche will continue to work with biologics CMOs despite its plans to spend CHF800m ($877m) on additional in-house production and development capacity.