Analytical (technologies & services)

Takeda teams with GammaDelta to develop novel cell therapies

12-May-2017 By Gareth Macdonald

Takeda has teamed up with GammaDelta Therapeutics to develop novel T-cell-based therapies in a deal that includes an option to buy the year-old UK biotech.

Industry 4.0 making its mark in biomanufacturing sector, Thermo Fisher

10-May-2017 By Dan Stanton

Integrating single-use, automation and continuous processing equipment will be the future for bioproduction says Thermo Fisher acquisition Finesse Solution.

Astrazeneca and Pieris team to develop mAb-like drugs for lung diseases

03-May-2017 By Gareth Macdonald

Astrazeneca has teamed up with Pieris Pharmaceuticals Inc to develop antibody like mini proteins for the treatment of lung diseases.

BPI Europe 2017

Roche on excipient inconsistencies: ‘Don’t blame suppliers, work with them’

02-May-2017 By Dan Stanton

An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.

DISPATCHES FROM BPI EUROPE 2017

CHO stopper? Biogen looks to alternative cell lines for future of bioproduction

28-Apr-2017 By Dan Stanton

The Chinese hamster ovary (CHO) cell line is not the future for biomanufacturing says Biogen, which will publish results from a study of alternative hosts later this year.

Thermo Fisher collaborates to establish single-use and automation site in China

27-Apr-2017 By Dan Stanton

Mab-Venture Biopharma has entered a collaboration to establish an antibody development and production plant in China incorporating Thermo Fisher’s single-use bioreactors and SmartFactory automated technology.

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US FDA warns Lonza about Walkersville site

25-Apr-2017 By Gareth Macdonald

The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.

Infographic

Hey big vendor... Is bioprocessing consolidation good for the end-user?

19-Apr-2017 By Dan Stanton

Price hikes and lack of innovation, or better buying power and end-to-end services? Experts are split on supplier M&A and its effect on biomanufacturers.

Synpromics announces £5.2M British investment in gene therapy tech

19-Apr-2017 By Flora Southey

Scottish synthetic biology firm Synpromics has received £5.2M ($6.6M) to enhance its synthetic promoter design technology used in gene therapy development.

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

19-Apr-2017 By Dan Stanton

Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.

Speed, yield and quality critical for cell line development, says ATUM

12-Apr-2017 By Dan Stanton

ATUM has launched itself into the mammalian cell line development space after being awarded patents for its Leap-In transposase genome technology.

Automation acquisitions 'capture the future of streamline production,' expert

12-Apr-2017 By Dan Stanton

There is a growing trend among vendors to integrate automation technologies into their offerings says a bioprocessing expert, as GE Healthcare invests in its partner Zenith.

GE Healthcare teams with CBMG to develop CAR-T and stem cell production tech

11-Apr-2017 By Gareth Macdonald

GE Healthcare has agreed to help Cellular Biomedicine Group (CBMG) develop CAR-T and stem cell production technologies to support its aim of making 10,000 cancer cell therapies a year.

Selling cell thawing: Medcision launches early adopter scheme to push tech

07-Apr-2017 By Gareth Macdonald

Medcision has started pushing its cell therapy thawing technology through an early adopter scheme designed to encourage adoption by firms with candidates in trials.

Dispatches from the 1st Stem Cell Community Day, Hamburg

UK Catapult: QbD and process automation key for making commercial cell therapies

05-Apr-2017 By Dan Stanton

Process automation should be incorporated early when developing large scale cell therapy manufacturing platforms, according to a lead scientist from the UK Catapult.

Eleven Biotherapeutics: Taking on ADCs with targeted protein therapeutics

28-Mar-2017 By Dan Stanton

A two-step manufacturing process makes antibody-drug conjugate production expensive and causes stability issues, says Eleven Biotherapeutics which is fusing antibody fragments to cytotoxic proteins.

Eurofins pumping $5m into a UK biopharmaceutical testing site

24-Mar-2017 By Dan Stanton

Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, Scotland.

US FDA fast-track designation for Humacyte's tissue-based hemodialysis product

22-Mar-2017 By Dan Stanton

Humacyte has received one of the first US FDA regenerative medicine designations for its investigational human acellular vessels (HAVs) candidate Humacyl.

Roquette aims to up its biologic reagent presence

17-Mar-2017 By Staff Reporter

Roquette says investments in packaging, documentation and testing requirements have helped the firm move into the biologics excipient and reagent space.

Horizon inks optimisation tech deal for next generation CHO K1 cell line

10-Mar-2017 By Dan Stanton

Horizon Discovery Group has teamed up with Amplycell to optimise its GS (glutamine synthetase) null CHO K1 cell line.

Biodefense: Canada develops novel live virus smallpox vaccine from horsepox

07-Mar-2017 By Dani Bancroft

Canada-based Tonix Pharmaceuticals has developed a novel live-virus vaccine for smallpox, which the firm claims is a safer alternative for biodefense stockpiles.

US FDA lifts hold on Seattle Genetics' blood cancer ADC candidate

07-Mar-2017 By Gareth Macdonald

The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths.

Sartorius ups bioanalysis business with $320m Essen acquisition

03-Mar-2017 By Staff Reporter

Sartorius’ third acquisition in the bioanalysis space in the past year will add Essen BioScience’s real-time live-cell analysis platform to its portfolio.

CRB sister Discovery launches second antibody catalogue

21-Feb-2017 By Dani Bancroft

Cambridge Research Biochemicals (CRB) has launched a second catalogue of research antibodies for academia, pharma and outsourcing firms.

Belgian CRO launches EU joint venture with Chromatography Institute

20-Feb-2017 By Dani Bancroft

The Research Institute for Chromatography (RIC) and Anacura have joined forces to create anaRIC biologics, an R&D and GMP analytical specialist CRO for biologics.

TiGenix hires Lonza to make cell therapy for Crohn's disease complications

17-Feb-2017 By Dani Bancroft

TiGenix is using Lonza as a US CMO and Takeda as an ex-US commercialization partner to launch and trial its off-the-shelf stem cell therapy for a complication of Crohn’s disease.

Charles River Labs up on biologics services

17-Feb-2017 By Staff Reporter

Charles River Laboratories says it is positioning itself to take advantage of growing demand for biological services.

Strategic CRO takes $100m hit from Pfizer's shelved PCSK9 candidate

17-Feb-2017 By Dan Stanton

Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.

Dutch Biopharma launches Phase III trial of Leukemia donor cell therapy

14-Feb-2017 By Dani Bancroft

Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.

BriaCell files CMC amendment and preps for breast cancer vaccine trial

10-Feb-2017 By Dani Bancroft

BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer.

GE teams with Austrian research centre to optimise cell line selection

10-Feb-2017 By Dan Stanton

GE Healthcare has teamed up with the Austrian Centre of Industrial Biotechnology (acib) in an effort to remove trial and error from the cell line optimization process.

Draper looks to ultrasound and geometry to reduce CAR-T manufacturing costs

07-Feb-2017 By Dani Bancroft

The Charles Stark Draper Lab has developed two microfluidic prototypes to help make the manufacturing of cell therapies cheaper and more efficient.

TapImmune improves T-cell vaccine formulation ahead of Ph II trials

03-Feb-2017 By Melissa Fassbender

TapImmune has completed a multi-gram scale-up and GMP manufacturing of its lead product as it prepares for various Phase II studies.

FINANCIAL REPORT

Thermo Fisher's cautiously optimistic outlook for 2017

02-Feb-2017 By Dani Bancroft

Thermo Fisher Scientific, Inc. saw revenue grow 8% in 2016, mostly due to acquisitions of new Chromotography and mass spectrometry tech and expanding its Bioproduction.

EDQM and EMA to clarify how Ph. Eur applies to biosimilars at event next week

31-Jan-2017 By Staff reporter

The EDQM and EMA aim to clarify how European Pharmacopoeia (Ph. Eur) monographs apply to biosimilars at an event next week.

Lundbeck banks on shark antibody delivery tech to cross blood-brain barrier

27-Jan-2017 By Dan Stanton

Shark antibodies are an attractive way to deliver biologics to the brain, says Ossianix which is using its blood-brain barrier (BBB) crossing technology in collaboration with Lundbeck.

FDA hits UK state-owned CDMO with warning over leukemia drug production

25-Jan-2017 By Dan Stanton

Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.

Mystery San Diego party inks $300m deal with Abzena for antibody linking tech

24-Jan-2017 By Dani Bancroft

An unnamed San Diego-based firm has signed a licensing agreement for Abzena Plc’s ThioBridge antibody drug conjugate (ADC) linker technology.

Amatsigroup buys French Pyrofree manufacturing specialist Disposable-Lab

23-Jan-2017 By Dani Bancroft

Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.

Horizon to use CRISPR tech to enhance CHO cell lines for biomanufacturing

17-Jan-2017 By Dan Stanton

Horizon Discovery Group has extended its CRISPR technology license to improve the performance of CHO cell lines for biomanufacturing.

GEA and Siemens team on continuous processing tech

17-Jan-2017 By Gareth Macdonald

Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.

Takeda in $125M deal for startup’s ‘unique’ Immuno-oncology platform

13-Jan-2017 By Dani Bancroft

Takeda has inked a 5-year deal to finance development of T-cell therapy redirection platform from recently founded biotech, Maverick Therapeutics, with exclusive right to buy.

OTCQB: PMCB

Cell-in-a-Box: PharmaCyte seeks FDA advice for inoperable cancer trial

06-Jan-2017 By Dani Bancroft

PharmaCyte has announced a pre-application meeting with the US FDA, to advise on their investigational new drug (IND) filing for a clinical trial its live cell encapsulation therapy.

COLD CHAIN

Cryoport to deliver Gradalis autologus immuno-oncology therapies across US

05-Jan-2017 By Dani Bancroft

Cryoport’s network of cold chain logistics will support the delivery of Gradalis Inc’s autologous cell therapy to various cancer trial sites across the US.

Synpromics to develop synthetic promotors for GE’s CHO platform

04-Jan-2017 By Dan Stanton

GE Healthcare hopes to increase the yield of biopharmaceuticals made using its Chinese Hamster Ovary (CHO) expression system through a partnership with synthetic biology firm Synpromics.

Prokarium and Probiomed team to scale-up thermostable oral vaccine

04-Jan-2017 By Dan Stanton

The project funded by the UK and Mexican governments will look to prove the scalability of Prokarium’s oral vaccine platform, the firm says.

US FDA delays Ocrevus decision date asking Roche for more manufacturing data

23-Dec-2016 By Gareth Macdonald

The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.

Pfizer turns to Charles Stark Draper Laboratory for 'organ-on-a-chip' tech

22-Dec-2016 By Dani Bancroft

The Charles Stark Draper Laboratory Inc. has inked a three year partnership with Pfizer to create personalised versions of Draper’s Microphysiological Systems (MPS), for cheaper and more effective preclinical testing.