Analytical (technologies & services)

Tokyo team developing stroke vaccine

23-Feb-2016 By Phil Hoad

Japanese researchers have developed a peptide vaccine with the potential to protect the brain when administered prior to a stroke, according to a study presented at the American Stroke Association’s International Stroke Conference.

EMA advocates more regular MRIs for MS patients on Biogen’s mAb Tysabri

17-Feb-2016 By Gareth Macdonald

Multiple sclerosis patients taking Tysabri (natalizumab) who are deemed to be at high risk for the lethal infection PML should have regular brain scans according to the EMA. 

AstraZeneca: Eli Lilly discovery pact won't raise competitive concerns

16-Feb-2016 By Gareth Macdonald

AstraZeneca has no competitive concerns about teaming with Eli Lilly to identify chronic kidney disease (CKD) targets.

All indications? Newer biosimilars may prompt US FDA extrapolation rethink says expert

29-Jan-2016 By Dan Stanton

While data extrapolation is acceptable in approving US biosimilars across the same indications as its reference, the practice will not be applicable for the next generation of copycat biologics, a biotech expert says.

Amatsigroup buys Q Biologicals in 'fragmented' EU bio-services space

27-Jan-2016 By Dan Stanton

French CDMO Amatsigroup will offer complete biologics development services and expand its European presence through the acquisition of Q Biologicals.

Danaher Q4: Life science demand and single-use growth attest Pall buy

27-Jan-2016 By Dan Stanton

Four months since acquiring Pall Corporation, Danaher has reported a 34% year-on-year increase in sales from its life sciences segment.

Sandoz welcomes US FDA promise to publish interchangeability guide in 2016

26-Jan-2016 By Gareth Macdonald

The US FDA plans to release long-awaited biosimilar ‘interchangeability’ guidelines in 2016 according to a publishing plan announced this week.

Sartorius launches crossflow tech for low volume filtration ops

26-Jan-2016 By Dan Stanton

Sartorius Stedim Biotech has launched a crossflow filtration system for scaling studies and low volume options normally available with process systems.

New Novozymes subsidiary Albumedix to develop its own drug pipeline says CEO

20-Jan-2016 By Gareth Macdonald

Novozymes’ new subsidiary Albumedix has announced its intention to develop biobetters and says the first candidate could be in Phase I trials by 2019.

Pfizer hits up four biotechs in $46m R&D collaboration strategy

19-Jan-2016 By Dan Stanton

Pfizer has invested $46m in separate collaborations with four R&D companies specialising in developing ADCs, immuno-oncology candidates and gene-therapies.

Roche and Catalent team up in $600m conjugation tech deal

15-Jan-2016 By Dan Stanton

Roche has collaborated with CDMO Catalent to access the SMARTag protein-modification and conjugation technology in a deal that could be worth up to $618m (€568m).

GE teams with Canadian Gov to set up C$40m cell therapy tech centre

13-Jan-2016 By Gareth Macdonald

GE Healthcare has teamed up with the Canadian Government and the Toronto-based Centre for Commercialization of Regenerative Medicine develop cell therapy manufacturing technologies.

Juno buys cell sequencing firm; set to license tech to CAR-T partner Celgene

13-Jan-2016 By Dan Stanton

T-cell receptor specialist Juno Therapeutics has added a next-generation single cell sequencing platform through the $125m acquisition of AbVitro.

Thermo Fisher to expand cellular analysis toolbelt in $1.3bn 'sensible' deal

12-Jan-2016 By Dan Stanton

Thermo Fisher will expand its antibody, multiplex RNA, and protein analysis tech offerings through the $1.3bn acquisition of Affymetrix.

Personalised tissue will change drug development, says researcher

08-Jan-2016 By Melissa Fassbender

A recently developed stem cell programming technique could produce human tissue on-demand for testing new drug treatments.

Waters to open analytical lab in UK biohub

07-Jan-2016 By .

Waters Corporation will offer an open access analytical laboratory and technology support  to biotechs based at a former AstraZeneca site in the UK.

Cell Therapy Catapult eyes gene and cell therapy partnerships

06-Jan-2016 By Natalie MORRISON

The Cell Therapy Catapult (CTC) UK is in talks over gene and cell therapy partnerships similar to its latest deal with Cancer Research Technology and the University of Birmingham, says Chief Business Officer Matthew Durdy.

Protea and Agilent collaboration looks to address drug discovery and QA/QC

15-Dec-2015 By Dan Stanton

Protea Biosciences has teamed up with Agilent Technologies to offer drugmakers mass spectrometry alternatives to UV detection in QA/QC of recombinant proteins.

Pfizer hails CAB tech in ADC licensing deal with Bioatla

08-Dec-2015 By Dan Stanton

Pfizer and Bioatla have licensed each other’s technology platforms to develop ADCs with Conditionally Active Biologic (CAB) antibodies as the payload delivery vehicles.

Fukushima scientists look to placenta-based cells to target radiation sickness

04-Dec-2015 By Dan Stanton

Researchers in Fukushima will use Pluristem’s placenta-based PLX-R18 cell therapy to investigate a treatment for Acute Radiation Syndrome (ARS).

Waters moves into Malaysia to tap growing bioprocessing market

01-Dec-2015 By Dan Stanton

Analytical and downstream technology firm Waters has opened a subsidiary in Malaysia, citing the steady and consistent growth of biopharma in the region as a driver.

Abzena to buy TCRS in latest boost to its ADC offering

24-Nov-2015 By Dan Stanton

Abzena is set to buy The Chemistry Research Solution (TCRS) in a deal one analyst says shows the firm’s intentions to dominate the bio-conjugation space.

Abcam buys AxioMx for antibody production technology

23-Nov-2015 By Staff Reporter

Abcam has acquired monoclonal antibody production specialist AxioMx in a deal worth up to $45m (€42m).

GE collaborates with Emerson on bioprocess automation tech

18-Nov-2015 By Dan Stanton

GE Healthcare has teamed up with Emerson Process Management to offer biomanufacturers increased automation from its single-use technologies.

Jobs

ABPI: fix the manufacturing skills gap now

11-Nov-2015 By Fiona BARRY

The UK biopharma industry is reporting difficulties finding manufacturing workers with the skills to make vaccines, biologics, and advanced therapy medicinal products (ATMP), according to ABPI.

CRL plans to pounce as pharma outsources more early discovery

05-Nov-2015 By Fiona BARRY

Charles River has reported strong Q3 sales despite weakness in Japan and plans to grab space in emerging early discovery, bio-testing and Chinese markets.

Lonza: industry should shift to QC automation

04-Nov-2015 By Fiona BARRY

While pharma is increasing use of automation and data integration tools in process development and manufacturing, it lags behind in electronic documentation of quality control, according to Lonza Biologics QC director Jessica Jean.

Malaria protein conjugate could deliver anti-cancer drugs, researcher

30-Oct-2015 By Anthony King

A protein in malaria could be used to deliver anti-cancer drugs to many types of tumours.

Thermo Fisher benefitting from blossoming biotechs, regardless of size

23-Oct-2015 By Dan Stanton

Thermo Fisher has positioned itself to capitalise on the success of small biotechs, the firm says as it reports flat third quarter results.

Intertek's CA bioanalytical lab expansion latest response to biopharma demand

22-Oct-2015 By Dan Stanton

An expanded San Diego facility will support demand for preclinical and clinical development services driven by the growth in the antibody and biosimilar sector, Intertek says.

Irish research hubs invent roaming reactor sensor

21-Oct-2015 By Fiona BARRY

A moving, wireless sensor in bioreactors could “revolutionise” biologics production, say the two Irish institutes which invented the wireless device.

Final designs for UK Gov-backed facility 'weeks away' says Cell Therapy Catapult CEO

13-Oct-2015 By Gareth Macdonald

The CEO of Cell Therapy Catapult says technical designs for the new UK biomanufacturing centre will be completed in the next few weeks.

Chemical synthesis of IL-10 cytokine 90% cheaper than bioproduction, Provepep

08-Oct-2015 By Dan Stanton

Chemical synthesis of peptides and proteins can be done at a tenth of the cost of bioproduction says French chemistry specialist Provepep.

Repositive launches free gene database for drug researchers

07-Oct-2015 By Gareth Macdonald

A UK firm has launched a searchable database of genomic data from sources all over the world that it says will accelerate development of personalised medicines.

“Money has returned to the market”: Envigo mulls biopharma role in preclinical recovery

29-Sep-2015 By Gareth Macdonald

Demand for biopharmaceutical testing is in part responsible for higher capacity utilisation but, despite encouraging signs, it is too early to say if preclinical pricing will improve accordingly says Envigo.

Car fumes increase Alzheimer's risk in people genetically predisposed, study

25-Sep-2015 By Gareth Macdonald

Air pollution increases the likelihood that people genetically predisposed to Alzheimer’s will develop the disease according to Mexican researchers.

Lack of regulatory clarity dominates US biosimilar debate post Zarxio

22-Sep-2015 By Gareth Macdonald

Sandoz has reiterated its call for US FDA guidance on biosimilar interchangeability arguing that the lack of clarity makes it hard to gauge what impact switching rules will have on pricing.

MedImmune will get first look at biologics ID'd at new UK lab says CRUK

16-Sep-2015 By Gareth Macdonald

MedImmune has first dibs on candidate cancer biologics identified at a lab the AstraZeneca unit set up with Cancer Research UK last week.

Trial supplies of candidate breast cancer radio-mAb still stable after 5 years says study

11-Sep-2015 By Gareth Macdonald

Trial supplies of a radio-immunotherapy drug made by Areva Med in compliance with GMP are stable five years after they were produced according to the results of new analysis.

Horizon to license haploid models to Abcam in deal worth up to $3m

09-Sep-2015 By Fiona BARRY

Horizon Discovery, a UK CRO, will license its cell lines to Abcam for use validating antibodies for up to $3m.

Many possible suitors for Pfizer’s biosimilar Infliximab, but no clear leader yet

01-Sep-2015 By Dan Rosenberg

Pfizer’s planned divestiture of its infliximab biosimilar candidate could create a race among competitors to gain access to the product, but in the early going, no clear leader has emerged.

UK bioindustry group calls for Government biomedical catalyst scheme to continue

21-Aug-2015 By Gareth Macdonald

The UK’s Biomedical Catalyst funding scheme encourages investors to back innovative biopharma research and should be continued according to the BioIndustry Association (BIA).

Diamond lights path to new antibiotic targets according to researchers

21-Aug-2015 By Gareth Macdonald

A protein called sigma54 that triggers bacterial stress responses to antibiotics could be a target for new anti-infectives say scientists.

Court allows Sandoz to launch first US biosimilar in September

22-Jul-2015 By Zachary Brennan

Novartis’ Sandoz unit will begin selling a biosimilar for Amgen’s cancer treatment Neupogen on September 2, thanks to an appeals court ruling released Tuesday.

Agilent and A*STAR to develop glycan analysis methods more suited to commercial setting

17-Jul-2015 By Gareth Macdonald

Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.

Sartorius buys Cellca for process dev knowhow

07-Jul-2015 By Gareth Macdonald

Sartorius Stedim Biotech SA (SSB) has acquired cell line and process development contractor Cellca GmbH.

Sequenom case leaves pharma confused over patent law

30-Jun-2015 By Fiona BARRY

US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer. 

TxCell to enhance operator training and sterilisation measures at cell therapy pilot plant

26-Jun-2015 By Gareth Macdonald

TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production this week.

Small-scale will be the next big thing says UK’s CPI

24-Jun-2015 By Gareth Macdonald

Small-scale production techs will dominate biopharma says the UK organisation tasked with developing the £20m “biologics factory of the future” and the £38m National Biologics Manufacturing Centre in Darlington.

|Dispatches from ACHEMA

Regulators play catch up with ever more complex manufacturing processes

18-Jun-2015 By Dan Stanton

EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.