Cell lines

Cash-strapped Epirus to sell CHO platform and biosimilar IP to Polpharma for $3.5m

15-Jun-2016 By Dan Stanton

As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma.

ProteoNic aims to provide biopharma with MSO-free alternative for cell selection

15-Jun-2016 By Gareth Macdonald

ProteoNic Biotechnology has licensed a vector gene delivery system to Horizon Discovery in a deal it hopes will attract firms looking to eliminate methionine sulphoximine from CHO cell selection processes.

BIO 2016

Technology, not capacity, driving Catalent’s biologics strategy

14-Jun-2016 By Dan Stanton

Differentiated technologies buoyed by the recent $600m conjugation deal with Roche is driving Catalent’s biologics business, the firm told Biopharma-Reporter at BIO.

Dispatches from BIO

GE and PnuVax ink vaccine deal and say single-use will change the industry

10-Jun-2016 By Dan Stanton

Single-use technology is driving a new era in vaccine development says PnuVax which has acquired IP from GE Healthcare to produce an inactivated yellow fever vaccine.

Lonza to make commercial gene therapies for Bluebird bio at new Texas site

10-Jun-2016 By Dan Stanton

Increased demand for gene therapy services will drive further investment in Lonza's capabilities, the firm says as it inks a strategic deal with Bluebird.

Replicating DNA structures is key to faster gene therapy vector manufacturing says Touchlight

10-Jun-2016 By Gareth Macdonald

Replicating secondary structures in viral DNA could be key to developing to faster AAV vector production methods according to UK tech firm Touchlight.

Kite and CDL to develop way of dialing down CAR-T activity for safer cell therapies

08-Jun-2016 By Gareth Macdonald

Kite Pharma and Cell Design Labs (CDL) have teamed up to develop “on/off” dials for CAR-T cell therapies that will reduce off site effects.

Stem cell therapy round-up: Off-the-shelf in India and 3D printing

01-Jun-2016 By Dan Stanton

India’s first off-the-shelf cell therapy product, StemCells Inc plummets on Phase II trial termination, and Accellta looks to 3D printing. Welcome to Biopharma-Reporter’s stem cell round-up…

Autologous insulin developer Orgenesis forms Israeli cell therapy JV

31-May-2016 By Dan Stanton

Orgenesis and Atvio have formed a cell therapy contract manufacturing joint venture and are looking to procure a GMP facility in Israel.

Safety board clears TxCell to restart Ovasave study that was halted last year

27-May-2016 By Gareth Macdonald

TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.

CGT to test scaffold tech for commercial-scale T-cell production

25-May-2016 By Gareth Macdonald

The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.

Evercyte and VTU team to develop animal-free cell growth media

25-May-2016 By Dan Stanton

Evercyte has teamed up with VTU Technology to develop cell culture media free from animal derived products, which the firm says is now essential for biomanufacturers.

US FDA accepts Samsung Bioepis' Remicade biosimilar for review

24-May-2016 By Gareth Macdonald

The US FDA has accepted Samsung Bioepis’ infliximab biosimilar – known as SB2 - for review.

Islexa to grow islets in lab to make transplants available to more Type I diabetes patients

18-May-2016 By Gareth Macdonald

A new UK company plans to grow pancreatic islets in the lab to enable more Type I diabetes suffers to receive transplants.

UK cell and gene therapy capacity hike signals long-term role says CGT

11-May-2016 By Gareth Macdonald

Recent capacity growth means the UK will be a cell and gene therapy hub for years to come according to the authors of a new manufacturing survey. 

Octapharma recalls Octagam lot in US

03-May-2016 By Gareth Macdonald

Octapharma has withdrawn one lot of its immune deficiency treatment Octagam after receiving reports of reports of allergic skin reactions in patients treated with the product.

Biotrinity 2016

CRISPR-Cas9 gene editing tech could eliminate orphan diseases, entrepreneur

29-Apr-2016 By Dan Stanton

CRISPR-Cas9 technology has the potential to eliminate orphan diseases, according to a British life science entrepreneur and investor.

Brexit bad for biosimilar developers says new industry group

22-Apr-2016 By Gareth Macdonald

Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).

update

US National Cancer Institute stops making cell therapy in light of contamination risk

20-Apr-2016 By Gareth Macdonald

Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.

Single-use and Stainless steel: Hybrid technologies the future of drug production says expert

20-Apr-2016 By Gareth Macdonald

Single-use is the future but stainless steel bioreactors will always play a role in drug production says an expert, who thinks firms could do worse than consult a CMO before deciding in which technology to invest.

Pluristem in talks with large Japanese firm interested in cell therapy pact

19-Apr-2016 By Gareth Macdonald

Pluristem is in partnership talks with a large Japanese pharmaceutical firm interested in its cell therapies for hematopoietic diseases.

Pluristem gets Japanese patent for 3D cell culturing method

15-Apr-2016 By Gareth Macdonald

Placenta-derived cell therapy developer Pluristem Therapeutics has been granted patents covering 3D culturing methods by the Japan Patent Office.

Dispatches from BPI Europe 2016

Looking to make third wave biosimilars? MOA crucial for cell line development, Formycon

15-Apr-2016 By Dan Stanton

Fully understanding a molecule’s mode-of-action (MOA) will be essential as industry begins developing the third generation of biosimilar products, according to Formycon.

Dispatches from BPI Europe 2016

GE Healthcare: Expanded Austrian plant incorporating ex-Thermo media business

12-Apr-2016 By Dan Stanton

GE Healthcare has expanded a facility in Austria to house the European wing of the Hyclone cell culture business it acquired from Thermo Fisher.

Dispatches from BPI Europe 2016

Roche: Bispecific and complex mAbs driving process development

12-Apr-2016 By Dan Stanton

The increasing complexity of biopharmaceuticals is driving process development innovation according to Swiss drug firm Roche.

Microbial or mammalian? BioSilta backs the former licensing E. Coli platform

08-Apr-2016 By Dan Stanton

Microbial expression systems are cheaper and more efficient than mammalian cell cultures says BioSilta which has acquired the rights to an E. coli based platform.

Eppendorf addressing stem cell scale-up challenges in Horizon 2020 project

08-Apr-2016 By Dan Stanton

Eppendorf will tackle the challenges of scaling-up human induced pluripotent stem cells (hiPSCs) as part of a Horizon 2020 project to develop cell-based heart therapies.

US Gov: Critical need for reproducible regenerative med manufacturing processes

06-Apr-2016 By Dan Stanton

Cell therapy firms must invest in engineering and learn from biopharma according to the US Government, which says high cost of regenerative treatments is slowing uptake.

Improved transposons could cut cell therapy production costs says EMBL

06-Apr-2016 By Gareth Macdonald

EMBL researchers have developed variants of the “sleeping beauty” transposon they claim are more effective at inserting genetic material into cells.

US FDA approves Celltrion's Remicade biosimilar

06-Apr-2016 By Melissa Fassbender

The FDA has approved its first biosimilar mAb, Remsima – a Remicade biosimilar from Celltrion.

BMS teams with Ireland's NIBRT to strengthen biomanufacturing processes

30-Mar-2016 By Dan Stanton

Bristol-Myers Squibb has announced plans to set up a biomanufacturing process laboratory in collaboration with Ireland's National Institute of Bioprocessing Research and Training (NIBRT).

Research shows neural stem cells strike a spinal cord in rat models

29-Mar-2016 By Dan Stanton

Researchers at the University of California have successfully regenerated corticospinal tract tissue in rat models using stem cell-derived neurons.

To affinity and beyond: Space age flow cytometry tech could aid cell therapy firms says LeukoDx

29-Mar-2016 By Gareth Macdonald

Know-how underpinning the tech astronauts use to detect infections in space could streamline cell therapy manufacturing according to new GE Healthcare partner LeukoDx.

Plasticell and Sphere team to make cell therapies cheaper

29-Mar-2016 By Gareth Macdonald

Plasticell has teamed up with encapsulation and screening tech firm Sphere Fluidics to develop genetic modification technology for cell therapy production.

Eiger sanctioned: Celladon shareholders agree merger

25-Mar-2016 By Gareth Macdonald

Eiger Biopharmaceuticals has merged with what is left of gene therapy developer Celladon in a deal that will see the combined firm list on the NASDAQ.

GE calls on diagnostics systems firm LeukoDx for cell characterization tech

25-Mar-2016 By Gareth Macdonald

LeukoDx will develop a cell characterization system for GE Healthcare in a deal designed to bolster the latter’s cell therapy manufacturing technology offering.

Hitachi Chemical licenses PCT tech and mulls cell therapy JV

23-Mar-2016 By Gareth Macdonald

Hitachi Chemical has licensed cell therapy manufacturing technology from PCT in a deal that may see the firms set up a European JV.

Meringue? No, you're not wrong: TxCell outlines unusual Ovasave delivery method

22-Mar-2016 By Gareth Macdonald

TxCell is working on new ways of delivering its Crohn's disease therapy Ovasave that will replace the somewhat unusual method it is using in clinical trials.

Samsung Bioepis says Eli Lilly visit was a courtesy meeting

18-Mar-2016 By Gareth Macdonald

Samsung Bioepis has denied it is about to do a biosimilars deal with Eli Lilly after the US drug firm visited its headquarters in Korea.

CHO business: Lonza launches reformulated media for biopharma's go-to cell line

15-Mar-2016 By Gareth Macdonald

Lonza has launched a reformulated CHO media that it says supports the growth of higher density cultures and is easier to filter than currently available products.

CAR T Cell firm Autolus raises £40m in Series B funding

15-Mar-2016 By Dan Stanton

UK-based drug developer Autolus has secured £40m ($57m) to develop its pipeline and license more T-cell engineering technologies from UCL.

Plant-based vaccines poised to challenge $4bn seasonal flu shot market

14-Mar-2016 By Phil Taylor

An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst.

3D culturing key to bone marrow therapy for Fukushima clean-up workers

11-Mar-2016 By Gareth Macdonald

A bone marrow therapy available to workers cleaning up after the Fukushima nuclear plant meltdown relies on a novel bioreactor tech that cultures cells in 3D.

HIV vaccine developer Theravectys says GMP suspension at Paris plant won't delay trial

09-Mar-2016 By Gareth Macdonald

Theravectys has outlined a 1-year plan to fix GMP deficiencies at its Paris facility and said the current manufacturing ban will not delay its clinical programmes.

ANSM bans production at Theravectys' Paris facility until September

07-Mar-2016 By Gareth Macdonald

ANSM has banned Theravectys from manufacturing candidate vaccines and immunotherapies at its Paris facility until September after observing critical GMP deficiencies during an inspection last year.

Bigger discounts will boost biosimilar prescribing say US physicians

04-Mar-2016 By Gareth Macdonald

The larger the discount the more likely a US physician is to prescribe a biosimilar rather than an originator biologic according to the results of a survey.

Cell culture market to reach nearly $19bn by 2020

02-Mar-2016 By Melissa Fassbender

The global cell culture market is expected to reach $18,630.7m by 2020, up from $11,310.9m in 2015.

TxCell's CMO completes test batch of candidate Crohn's therapy; contractor training center set up

01-Mar-2016 By Gareth Macdonald

MaSTherCell has completed test runs of T-cell therapy Ovasave says TxCell which has reiterated its intention to restart a trial of the drug in Crohn's disease this year.

Tarantula toxin may yield non-opioid treatments for chronic pain

01-Mar-2016 By Gareth Macdonald

A tarantula venom toxin that inhibits a novel pain receptor will guide development of more effective non-opioid painkillers say researchers in Australia.

JHL completes assembly of GE built off-the-shelf plant in Wuhan, China

29-Feb-2016 By Gareth Macdonald

JHL has completed “mechanical construction” of an off-the-shelf mAb plant in Wuhan, China days after UK regulators gave the go ahead for a trial of its rituximab biosimilar, JHL1101.