Analytical (technologies & services)

USP offers support for WHO’s biological qualifier plan

26-Sep-2014 By Zachary Brennan

USP (US Pharmacopeia) is offering its support for efforts from the WHO to develop a global approach to the naming of all biologics.

Mega deals like Merck-Sigma cut biopharma bargaining power says leading CMO

24-Sep-2014 By Gareth Macdonald

Life science sector consolidation is a concern for some biomanufacturers, who say mega mergers like Merck KGaA’s $17bn acquisition of Sigma-Aldrich will limit their ability to negotiate on prices.

Media moguls: Merck KGaA squares up to Thermo and GE with $17bn Sigma buy

23-Sep-2014 By Gareth Macdonald

Merck KGaA has continued its diversification effort with a $17bn (€13bn) bid for Sigma Aldrich that will see it battle Thermo Fisher and GE Healthcare for a share of the life sciences tools and supplies market.

Boehringer Ingelheim licenses CureVac mRNA vaccine for up to $600m

23-Sep-2014 By Zachary Brennan

Boehringer Ingelheim will pay mRNA drug developer CureVac up to €465m ($600m) for an exclusive global license and development collaboration on CureVac’s potential mRNA vaccine in early clinical development for the treatment of lung cancer.

Pfizer eyes Parkinson’s disease treatments with MedGenesis pact

19-Sep-2014 By Zachary Brennan

Biotech company MedGenesis Therapeutix has granted Pfizer an exclusive, worldwide option to license its glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery (CED) technology to be used in research for potential treatments...

Baxter to spin off biopharma assets to form new ‘Baxalta’

12-Sep-2014 By Zachary Brennan

Baxter International will spin off its biopharmaceutical treatments and manufacturing facilities to form a new company known as Baxalta, which is expected to launch in mid-2015.

Shifting pipelines drive AMRI to expand protein expression services

05-Sep-2014 By Dan Stanton

AMRI has added protein expression and purification services to its drug discovery services citing the shift in pipelines towards larger molecule drugs as a driver.

Expert: Use fluid dynamics to navigate murky waters during scale-up

03-Sep-2014 By Gareth Macdonald

Biopharmas scaling-up production should use fluid dynamics to make better predictions about bioreactor performance according to one expert, who says engineers can use it to test multiple configurations more rapidly.

Thermo Fisher raises guidance on 'fabulous' biopharma services growth

25-Jul-2014 By Dan Stanton

The biopharma services market keeps expanding and “growth prospects look fabulous,” says Thermo Fisher, reporting better than expected sales across its Life Sciences business for the second quarter 2014.

Biopharma Briefs

18-Jul-2014 By Staff Reporter

Latest biopharma news in brief.

Particle Sciences adds biopharma analysis capabilities ahead of schedule

16-Jul-2014 By Gareth Macdonald

Particle Sciences has beefed up its biopharmaceutical testing capabilities ahead of schedule in response to customer demand.

UK to set up personalised meds focused manufacturing tech test centre

11-Jul-2014 By Gareth Macdonald

A new UK “biologics facility of the future” (FoF) testing centre will let biopharma tech firms develop smaller-scale manufacturing systems for personalised medicine production according to the Centre for Process Innovation (CPI).

US FDA offers draft guidance on conducting shedding studies for gene therapies

11-Jul-2014 By Zachary Brennan

The draft guidance aims to provide sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical...

Bio-techne boosts antibody portfolio with $60m Novus acq

09-Jul-2014

Protein manufacturer Bio-Techne has expanded its purified proteins portfolio through the $60m (€44m) acquisition of antibody developer Novus Biologicals.

60-year old smallpox found in US FDA lab may still be viable, if only live vaccines lasted as long

09-Jul-2014 By Gareth Macdonald

For live vaccine manufacturers working to extend shelf-life, the discovery that 60-year old smallpox virus found at a US Food and Drug Administration (FDA) lab could still be viable will be as galling as it is worrying.

‘Why do we put that in?’ SAFC analyses cell culture media

02-Jul-2014 By Fiona Barry

A programme by SAFC is characterising raw materials to reduce delays and cell death in biologics manufacturing, its head of R&D tells BioPharma-Reporter.com.

Synthon contracts Antitope for ADC testing

02-Jul-2014

Synthon has called on UK immunogenicity testing firm Antitope to analyze its pipeline of antibody drug conjugate (ADC) candidates.

BioOutsource targets biosimilars testing growth with new US lab

01-Jul-2014 By Gareth Macdonald

US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.

Roche: ‘If suppliers don’t open up their books, then we are done’

18-Jun-2014 By Fiona Barry

Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.

Arecor and CPI team on biologics stability research project

17-Jun-2014 By Gareth Macdonald

Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.

Pfizer retracts third figitumumab study citing data discrepancies

17-Jun-2014 By Gareth Macdonald

Pfizer has asked for a 2010 research paper examining its discontinued cancer mAb figitumumab to be retracted after discovering data discrepancies.

Demand for pre-prepared media drives Cherwell expansion

13-Jun-2014 By Dan Stanton

Increased regulatory expectation in the environmental monitoring of microbiological media has driven demand for prepared solutions, says Cherwell Laboratories as it completes a facility expansion.

We’re gonna need a bigger bond: studying sharks to make better mAbs

10-Jun-2014 By Gareth Macdonald

Shark antibodies survive in urea concentrations that would denature other proteins thanks to a newly discovered structure that scientists say could be used to make therapeutic mAbs more robust.

Malvern moves for microcalorimeter tech in pharma-focused acquisition

10-Jun-2014 By Gareth Macdonald

Malvern Instruments will buy GE Healthcare’s MicroCal business in a deal that adds protein analysis and formulation development tech to its expanding drug industry offering.

'Tech platform spurred Lucentis biosimilar,' says Pfenex in $75m IPO

10-Jun-2014 By Dan Stanton

Pfenex has filed for an initial public offering to raise $75m to develop biosimilars using its protein producing Expression Technology platform.

Thermo and Cellectis shake hands over Talen gene editing tech for biopharmas

06-Jun-2014 By Gareth Macdonald

Thermo Fisher Scientific has licensed rights to gene editing technology for bioproduction applications that it claims targets DNA more precisely and reliably than current approaches.

Inside NIBRT: Ireland’s 'flight simulator for biopharma manufacturing'

27-May-2014 By Dan Stanton

A government funded bioprocessing institute is helping to drive biopharma investment and retrain workers in Ireland, and Biopharma-Reporter.com visited to find out what happens in this "flight simulator for biopharma manufacturing."

Biopharm launches modelling tool to slash process development costs

21-May-2014 By Fiona Barry

Biologics makers must think about costs surrounding chronic therapies and continuous processing, says a company making software predicting manufacturing scenarios.

UCB aims to halve antibody discovery time with robot

09-May-2014 By Fiona BARRY

UCB has launched a robot it says can halve antibody discovery time.

Waters sees chromatography growth despite flat Q1

30-Apr-2014 By Dan Stanton

Bioprocessing instrument manufacturer Waters has reported a flat Q1, but management predicts new products and a delayed release of capital from large pharma will lead to growth in 2014.

Biopharma turns to outsourcing for more common, simple tasks, survey finds

29-Apr-2014 By Zachary Brennan

Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.

Quality of Life shown in robust Q1 for Thermo Fisher

23-Apr-2014 By Dan Stanton

Q1 revenues for Thermo Fisher’s Life Sciences Solutions business shot up 384% year-over-year in a quarter that saw the integration of Life Technologies.

Thermo Fisher: new pumps compatible with all bioprocessing techs

16-Apr-2014 By Gareth MACDONALD

Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.

Integrity test helps assure no flaws in single-use systems, says ASI

09-Apr-2014 By Dan Stanton

ASI has developed a last-chance confidence test for single-use biomanufacturers looking for assurance there are no flaws in their bioreactor bags.

Takeda to license Trianni mAb discovery platform

08-Apr-2014 By Zachary Brennan

Takeda has entered into a license agreement for the use of the Trianni Mouse, a monoclonal antibody discovery platform.

Austrianova picks A*STAR microfluidics platform for cell dispensing

04-Apr-2014

Cell transportation technology firm Austrianova has licensed a low-cost, disposable microfluidics platform from SIMTech to improve how it dispenses cells used in biomanufacturing and therapeutic applications.

Aspyrian and Goodwin team to 'shed light' on ADC candidate

26-Mar-2014 By Dan Stanton

Aspyrian Therapeutics has teamed up with Goodwin Biotech to make antibody-drug conjugates (ADCs) with a technology platform that uses near‐infrared (NIR) light to activate the cytotoxin.

DISPATCHES FROM INTERPHEX

So far, so very good: Pall and ATMI talk integration at interphex

21-Mar-2014 By Dan Stanton

While there will always be space for stainless steel systems, single-use technology is now mainstream according to Pall and ATMI.

DISPATCHES FROM INTERPHEX

To QbD or not to QbD? For biologics it's a must says Cook Pharmica expert

19-Mar-2014 By Dan Stanton

The thorny issue of applying QbD to biopharmaceutical manufacture is a topic of hot debate at Interphex 2014 according to CMO Cook Pharmica.

Start spreading the news, Interphex opens today

18-Mar-2014

When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.

EMD Millipore wins $400K grant from Massachusetts for Promethera partnership

14-Mar-2014 By Zachary Brennan

In what may be an early indication of states looking to get more involved in biologic development, EMD Millipore has won a $400,000 grant from the Massachusetts Life Sciences Center (MLSC) to fund a partnership with Promethera Biosciences.

Daiichi’s downstream setback cuts Japanese H5N1 vaccine supplies

12-Mar-2014 By Gareth Macdonald

Less H5N1 influenza vaccine than expected will be available in Japan this year after downstream processing problems at a plant being set up by Daiichi Sankyo.

Thermo Fisher talks Life integration and long-term synergies

12-Mar-2014 By Dan Stanton

An analyst predicts overlap between Thermo Fisher and Life Technologies will present manufacturing, procurement and logistics cost-saving opportunities.

AB Sciex begins offering ‘breakthrough’ upstream processing tech

05-Mar-2014 By Zachary Brennan

AB Sciex has launched what it claims is the first commercially available ultra-low flow electrospray ionization instrument that links CE (capillary electrophoresis) technology to mass spectrometry.

Pfizer, MIT in 3-year collaboration focusing on biologics manufacturing

25-Feb-2014 By Zachary Brennan

Pfizer and MIT have announced a new three-year collaboration to advance biopharmaceutical discovery using synthetic biology.

BioOutsource partners with Glythera on ADC characterization

21-Feb-2014 By Zachary Brennan

Contract Testing Organization (CTO) BioOutsource has partnered with Glythera to characterize their ADC (antibody drug conjugate) in development.

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.

Majority of EU member states say ‘no’ to INNs for biosimilars

19-Feb-2014 By Zachary Brennan

Most EU member states “strongly supported” the idea that biosimilars should be closely aligned with their reference products, according to a summary of the European Commission’s pharmaceutical committee meeting released Monday.

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.