Cell lines

Cobra and Manchester Uni receive grant for biologics scale-up

24-Sep-2015 By Fiona BARRY

Cobra Biologics, a Swedish contract development and manufacturing organisation, has launched a project to improve scale-up of biologics with the University of Manchester, UK.

Regeneron to make mAb Ebola drug for trials with BARDA backing

23-Sep-2015 By Gareth Macdonald

Regeneron Pharmaceuticals will use it speedy mAb development tech to move an Ebola drug into clinical trials under a $38m (€34m) US Government contract.

CRISPR

UK asks to use CRISPR on human embryos

22-Sep-2015 By Fiona BARRY

UK scientists have applied to the country’s fertility regulator for permission to use CRISPR and other genome editing techniques on human embryos.

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.

Lonza launches extra pluripotent cell lines

21-Sep-2015 By Fiona BARRY

Lonza has expended its stem cell portfolio to offer hMSCs for translational and cell therapy research.

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.

Polpharma hires key member of Sandoz's US Zarxio launch team as biosimilar head

11-Sep-2015 By Gareth Macdonald

Polpharma has hired one of the architects of Sandoz’s recent US Zarxio launch to lead its biologics division.

Aragen Bioscience licenses protein yield boosting tech for cell line development

09-Sep-2015 By Gareth Macdonald

ProteoNic Biotechnology BV has licensed its protein production technology to US contractor Aragen Bioscience.

Epirus to buy CHO tech and biosimilar developer Bioceros

09-Sep-2015 By Dan Stanton

Epirus Biopharmaceuticals will bolster its biosimilar pipeline and gain a CHO platform through a $14m acquisition of Bioceros Holding.

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.

Gain-of-function study finding may accelerate flu vaccine production

08-Sep-2015 By Gareth Macdonald

Influenza research completed just before the US banned ‘gain-of-function’ studies could help vaccine makers boost virus yields and accelerate production say scientists.

Boehringer-Ingelheim licenses microbial expression tech for in-house and out

02-Sep-2015 By Dan Stanton

Boehringer Ingelheim has licensed a microbial expression technology from Vectron Biosolutions for use with its own molecules and for customers through its CMO business.

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.

Veterans suited to pharma says Texas A&M

01-Sep-2015 By Gareth Macdonald

Army training is ideal preparation for a biopharma career according to the US National Center for Therapeutics Manufacturing, which is seeking former military personnel interested in learning about bioprocessing.

Phage therapy firm Ampliphi to list on NYSE

19-Aug-2015 By Gareth Macdonald

Phage therapy developer AmpliBphi Biosciences has been cleared to list on the New York Stock Exchange’s MKT market.

Report: UK capacity for cell, gene therapy manufacturing decreases in 2015 as new projects launch

19-Aug-2015 By Zachary Brennan

A surge in UK cell therapy production last year means available manufacturing capacity has declined considerably according to a report by Cell Therapy Catapult.

Pfenex, Emergent win multi-million dollar US government contracts

18-Aug-2015 By Zachary Brennan

Contract manufacturer Emergent BioSolutions and biosimilar developer Pfenex have both announced in recent days that they’ve won contract manufacturing and development grants with the US government.

$17bn Pfizer-Hospira merger approved on anti-trust conditions

05-Aug-2015 By Fiona BARRY

The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.

Stem cell factories: New substrate opens door to mass produced regenerative therapies

24-Jul-2015 By Gareth Macdonald

Mass produced regenerative therapies are a step closer say UK researchers who have developed a polymer substrate they claim can be used to set up “stem cell factories.”

Stem Cell Theranostics secures "freedom to operate" in IP deal with GE Healthcare

21-Jul-2015 By Gareth Macdonald

Stem Cell Theranostics has secured rights to the technology it uses to make cellular heart disease models for drug development through a deal with GE Healthcare.

Perfusion and chromatography beat ALS cell therapy production challenges, says Goodwin

17-Jul-2015 By Dan Stanton

Goodwin Biotechnology says making trial supplies of Q Therapeutics’ amyotrophic lateral sclerosis (ALS) cell therapy meant overcoming considerable technical hurdles.

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.

CNS drugmaker teams with CDMO on ALS mAb candidate

15-Jul-2015 By Fiona BARRY

CDMO (contract development and manufacturing organisation) Goodwin Biotechnology is working with CNS biotech Q Therapeutics to produce mAbs for a clinical trial to treat motor neuron disease.

German firm joins CAR-T party

10-Jul-2015 By Fiona BARRY

German biopharma apceth has announced a CAR T-cell immunotherapy partnership with the University of Cologne.

Report: Outsourcing becoming more mainstream in biomanufacturing industry

08-Jul-2015 By Zachary Brennan

As biopharmaceutical companies look to cut costs and understand their core competencies further, the use of outsourcing and off-shoring have become even more mainstream than in years past, according to the 12th annual biomanufacturing report from BioPlan...

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.

Lonza to set up dedicated manufacturing suite for Alexion

02-Jul-2015 By Gareth Macdonald

Lonza will set up a dedicated manufacturing suite for Alexion, producer of the world’s most expensive drug Soliris.

Samsung Bioepis mulls NASDAQ IPO to raise cash for biosimilars

01-Jul-2015 By Gareth Macdonald

Samsung Bioepis is considering an IPO on the NASDAQ Stock Exchange to raise cash to fund the development of biosimilar products.

US FDA accepts IND for TxCell's Crohn's cell therapy; Firm eyes European CRO for US trial

30-Jun-2015 By Gareth Macdonald

TxCell is set to expand a trial of its candidate Crohn’s disease cell therapy to the US after the FDA accepted its IND application.

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.

UK scientists discover key poppy alkaloid production enzyme

25-Jun-2015 By Gareth Macdonald

GSK and UK academics claim a newly identified enzyme is the missing link in the mechanism poppies use to make painkilling alkaloids like morphine and codeine and the anticancer compound noscapine.

Scientists create 3D multiple myeloma model to aid preclinical development efforts

22-Jun-2015 By Anthony King

Scientists have developed a new way of visualizing multiple myelomas in 3D by replicating tumours in hens’ eggs in a approach they say will aid drugmakers.

Phos enzyme ID'd using CRISPR may lead to safer cancer meds say researchers

19-Jun-2015 By Gareth Macdonald

A newly identified enzyme that modifies secreted proteins could lead to safer cancer drugs and new osteoporosis treatments say scientists.

|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.

Aragen and Transposagen launch knockout cell line for mAb development

17-Jun-2015 By Gareth Macdonald

Aragen Bioscience and Transposagen Biopharmaceuticals have launched a knockout CHO cell line and development services they clam allows for the development of more effective therapeutic mAbs.

GSK backs US cell genetics institute; more takeover rumours

17-Jun-2015 By Gareth Macdonald

Rumoured Big Pharma takeover target GSK has invested $95m to set up an cell genetics research institute to help developers better identify drug candidates.

Mammary glands in a dish: Scientists recreate tissues for better models; spin out CRO planned

15-Jun-2015 By Gareth Macdonald

Researchers say a hydrogel that prompts cells to form tissue-like structures in vitro could be used to make more accurate preclinical disease models.

More use of STR to identify cell lines would save billions of dollars says researchers

12-Jun-2015 By Gareth Macdonald

Correctly identifying cell lines used in cancer drug development would cut the amount US researchers spend on preclinical research that cannot be reproduced.

Allele buys CA plant for 'footprint free' stem cell production

12-Jun-2015 By Dan Stanton

California-based Allele has bought a facility to manufacture human induced pluripotent stem cells (hiPSCs) using its “footprint-free” synthetic mRNA technology.

update

EIB loans Poland's biggest drugmaker €45m to develop biosimilars

10-Jun-2015 By Gareth Macdonald

The European Investment Bank (EIB) has loaned Polpharma €45m to fund development of biosimilars and improve access to medicines in Europe.

update

Data from all UK-funded vaccine trials to be published says PM

10-Jun-2015 By Gareth Macdonald

Results from all UK-funded vaccine trials will be made public according to Prime Minister David Cameron, who suggested failure to share data exacerbated the Ebola outbreak.

Duck cells for Ebola vaccine production: ProBioGen highlights Emergent's use of tech for MVA EBOZ

09-Jun-2015 By Gareth Macdonald

Emergent Biosolutions’ Ebola vaccine is the first to be made in cells rather than the hens’ eggs according to production tech developer ProBioGen.

update

The age of phage? World first cGMP certification for phage therapy plant

03-Jun-2015 By Gareth Macdonald

AmpliPhi Biosciences’ phage-based antibacterial therapies plant in Ljubljana has been deemed to meet manufacturing standards by Slovenian regulators.

Mexican scorpion research could yield cancer and Parkinson's disease drugs

03-Jun-2015 By Gareth Macdonald

Proteins found in scorpion venom could yield cancer and Parkinson’s disease drugs say Mexican researchers.

Pluristem outlines cell therapy production plan after securing patents in future markets

02-Jun-2015 By Gareth Macdonald

Pluristem Therapeutics will set up manufacturing sites and find local partners to make cell therapies for the Chinese, Korean, Mexican, Russian and Israeli markets after securing various patents this week.

Unique biologics pipelines driving biomanufacturing innovation, Deloitte says

02-Jun-2015 By Zachary Brennan

The adoption of new technologies related to single-use bioreactors, disposable plastic containers, continuous purification processing, and real-time quality analysis are driving the next generation of biomanufacturing, according to a new report from the...

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