Analytical (technologies & services)

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.

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.

Thermo: SDS Page price cuts in keeping with China's 5-year plan

06-Feb-2014 By Gareth Macdonald

Thermo Fisher Scientific has confirmed that the price cuts imposed by Chinese M&A authorities are part of the country’s efforts to become and biopharmaceutical hub.

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.

special report

FTC workshop: Questions remain on biosimilar troubles in the US

05-Feb-2014 By Zachary Brennan

It is no clearer how the US will govern biosimilar naming, approval and substitution despite a day-long Federal Trade Commission (FTC) workshop that produced heated debate but few concrete answers.

Thermo Fisher: 'Life begins in February,' as it awaits FTC approval

31-Jan-2014 By Dan Stanton

Thermo Fisher has predicted its $13.6bn takeover of Life Technologies will be completed in February as it reports strong FY 2013 results.

Benchtop mass spec tech could offset low biopharma demand for Waters

15-Jan-2014 By Dan Stanton

Subdued demand from Biopharma for its chromatography equipment could be reversed by its benchtop mass spectrometry technology, Waters says.

EBE says EC must do more on biodrug assessments

18-Dec-2013

A biomanufacturing industry group has rejected the European Commission’s view that current regulations are flexible enough to apply to biopharmaceuticals and says more need to be done.

Norway to facilitate switch to biosimilars with $3m Remicade study

06-Dec-2013 By Dan Stanton

The Norwegian Health Department has committed 20m NOK ($3.3m) to a study in order to facilitate the use of biosimilars.

SGS France lab cleared to release biopharma batches

04-Dec-2013

SGS has been cleared to conduct tests for the batch release of biopharmaceutical products at its laboratory in Poitiers, France.

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.

Bioinvent has 'FIRST' for antibody discovery as tech receives US patent

13-Nov-2013 By Dan Stanton

Bioinvent has been granted a US patent for its FIRST screening platform and says it is unique in selecting antibodies without any prior knowledge of target identities.

Thermo Fisher awaits regulatory nod for Life Tech acquisition

08-Nov-2013 By Dan Stanton

Thermo Fisher has applied to the EU and New Zealand’s competition commissions for approval of its acquisition of Life Technologies.

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...

Merck Serono, Ablynx re-up for fourth partnership on nanobody discovery

04-Oct-2013 By Zachary Brennan

Ablynx and Merck Serono expanded their relationship for a fourth time – this time in a four-year deal worth about $34m (€25m), including an initial payment of $15.5m (€11.5m).

SSB says new dishes cut contamination risk in QC testing

02-Oct-2013 By Gareth Macdonald

Sartorius Stedim Biotech (SSB) has launched a new range of culture media dishes designed cut the risk of contamination during lab analysis of facility microbiological QC samples.

SAFC launches new CHO lines for protein drug developers

01-Oct-2013

A new knock-out cell line developed by SAFC promises to make crystallography studies more effective and –potentially – safer therapeutic proteins.

MIT scientists develop new nanoparticles to improve vaccine delivery

27-Sep-2013 By Zachary Brennan

MIT engineers have developed a new nanoparticle that can protect a vaccine long enough to generate a strong immune response on mucosal surfaces far from the vaccination site.

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.

Shire taps antibody discovery platform using llama immune systems

20-Sep-2013 By Zachary Brennan

A new platform to help biopharma companies discover antibodies is also helping them go after more difficult targets and earn more collaborations with top biopharma companies.

FDA: Draft guidance on bioanalytical validation reflects tech advances

18-Sep-2013 By Zachary Brennan

The updated draft guidance calls for fully validated bioanalytical methods for any pivotal studies used to obtain approval or labelling, though less validation may be sufficient for a sponsor’s internal decision making.

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.

Harvard’s New Melanoma Vaccine Tech Enters Ph I Trial

11-Sep-2013 By Zachary Brennan

A newly developed implantable melanoma vaccine is now in Phase I clinical trials thanks to the efforts of a cross-disciplinary team of engineers, scientists and clinicians from Harvard University and the Dana-Farber Cancer Institute.

Ultrasensitive Immunoassay Tech Aims to Help Discover New Biomarkers

06-Sep-2013 By Zachary Brennan

Biopharma researchers will be able to use a new technology to explore biomarkers and pathways with more sensitivity and precision to create new diagnostics and improved oncology, neurology, cardiology and other therapies.

Sanofi Buys Freeslate’s Biologics Formulation System

04-Sep-2013 By Zachary Brennan

Sanofi Pasteur has purchased Freeslate’s biologics formulation system to accelerate its vaccine research and protein development programmes.

Waters Poring Over Candidates After CEO Announces Retirement Plan

28-Aug-2013 By Gareth Macdonald

Mass spec, chromatography and analytical tech firm Waters has started its search for a new CEO based on the assumption it will remain independent and keep the same growth strategy.

Small Sensors, Big BioPharma Potential Say Scientists

23-Aug-2013 By Gareth Macdonald

Large arrays of identical nanosensors could improve MAb production, identify glycosylation and pinpoint the best cell lines for biomanufacturing say US researchers.

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.

Agilent Looks to Expand Access to Biomarker Discovery Platform

16-Aug-2013 By Zachary Brennan

Agilent Technologies is partnering with SomaLogic to expand the dissemination of Soma’s proteomic assay to at least five academic and contract research centers by the end of the year as demand for the tool has skyrocketed among biopharma companies.

Heat Stabilization Tech Aims to Overcome Limitations in Mass Spec Imaging

02-Aug-2013 By Zachary Brennan

New heat stabilization technology can preserve the quality of tissue samples used in mass spectrometry imaging to improve the accuracy of downstream analytical results.

Roche Launches Iron and Phosphate Test Reagents for BioPharmas

31-Jul-2013 By Gareth Macdonald and Dan Stanton

Roche has added iron and phosphate to the list of metabolites BioPharmas can detect and quantify using its process analytics technology.

Company Results

Sartorius: Single-Use Demand in Europe and Asia Offsets Rev Decline North America

26-Jul-2013

Increased demand for single-use tech from Europe and Asia offset lower North American sales and help Sartorius’ bioprocess solutions division drive company-wide growth.

AB Sciex, Beckman Coulter Combine Chromatography, CE Biz as Part of Biologics Push

26-Jul-2013 By Zachary Brennan

AB Sciex is combining its chromatography business with the capillary electrophoresis (CE) business from Beckman Coulter (BC) to align BC’s expertise in microscale separation with AB’s expertise in microfluidics.

To QbD or not to QbD? That is the Question...

24-Jul-2013 By Dan Stanton

Europe may soon approve the first biologic made according to quality by design (QbD) principles, but opinions are still split over whether the approach should even be applied to biopharmaceuticals.

Sartorius and BlueSens Partner on Microbial Gas Sensor Tech

24-Jul-2013 By Dan Stanton

Industry has been slow to implement single-use technologies for microbial cultivations, according to Sartorius which has launched a new bioreactor gas sensor.

Chinese Market for Nucleic Acid Purification Expected to Grow Rapidly, Report Finds

24-Jul-2013 By Zachary Brennan

With the Chinese NAP (nucleic acid purification) market expected to grow more than 8% over the next year and no clear market leaders, companies are looking to take control of the industry space.

Immunocore CEO: 3rd Big Pharma Eying Unique Cancer Targeting Tech

17-Jul-2013 By Dan Stanton

Immunocore is looking for more licensees for its cancer targeting technology following recent discovery and development deals with GSK and Genentech.

Technology News Is Vital for BioPharmas MIT Prof Tells BioPharma-Reporter.com

16-Jul-2013 By Gareth Macdonald

Keeping up with the latest technology news is a must for biomanufacturers according to an MIT Professor who told BioPharma-Reporter.com new advances in microtechnologies could help address process development challenges.