Cell lines

Heat Biologics stops enrolment in trial arm testing HS-410 as a bladder cancer monotherapy

25-Feb-2016 By Gareth Macdonald

Heat Biologics will no longer enrol patients in the arm of a Phase II trial examining its cell therapy HS-410 (vesigenurtacel-L) as a monotherapy for bladder cancer.

Cobra Biologics and UK CPI team on AAV vector production platform

25-Feb-2016 By Gareth Macdonald

Cobra Biologics and the UK Centre for Process Innovation (CPI) will develop a manufacturing system for the viruses used to deliver gene therapies.

T Cell therapies 'Heat' up as biotech looks to third public offering

24-Feb-2016 By Dan Stanton

Heat Biologics hopes to raise an additional $14m (€13m) to support its T Cell therapy pipeline made using its allogeneic production platforms.

Cell Therapy Manufacturing & Gene Therapy Congress - Brussels, Belgium

Pall's Xpansion bioreactor chosen for 'world's largest cell bank' scale-up

23-Feb-2016 By Dan Stanton

Scaling-up without expanding its manufacturing footprint was key in selecting Pall's Xpansion bioreactor, says UCL which is looking to create “the world’s largest therapeutic cell bank.”

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.

Cell Therapy Manufacturing & Gene Therapy Congress - Brussels, Belgium

Short shelf-life poses problems for cell therapy makers, Chiesi

19-Feb-2016 By Dan Stanton

The shelf life of a cell therapy product is crucial in determining a firm’s manufacturing strategy according to the makers of the first approved stem-cell based drug.

Telephus gets patents for superbug battling antibodies

12-Feb-2016 By Gareth Macdonald

Australia has granted Telephus Medical a patent for an antibody that targets superbugs, including MRSA.

Cell Therapy Manufacturing & Gene Therapy Congress, Brussels

Supply chain fears drive in-house tech for CAR-T cell developers

10-Feb-2016 By Dan Stanton

Reliance on third-party technologies is leaving T-Cell drug developers vulnerable and has driven the larger players to invest in their own platforms, say experts.

Lonza to make Kodiak Sciences' eye drug candidates

09-Feb-2016 By Gareth Macdonald

Lonza has been contracted to make candidate antibody-based drugs for retinal diseases by California, US biotech Kodiak Sciences.

Dispatches from the Cell Therapy Manufacturing & Gene Therapy Congress

Bovine-derived media still 'gold standard' despite safety and reliability concerns, expert

05-Feb-2016 By Dan Stanton

Bovine serum remains the gold standard in cell culture supplements despite its many flaws, says Cook Regentec.

Japan’s PuRec to supply mesenchymal stem cells

05-Feb-2016 By Wang Fangqing

Regenerative medicine developers now have a new supplier for mesenchymal stem cells (MSCs), the multipotent stromal cells derived from marrow and other tissues like muscle and dental pulp for tissue repair.

Reneuron gets US patent for non-toxic cell cryopreservation system

02-Feb-2016 By Gareth Macdonald

Reneuron has been granted a US patent for a cryopreservation technology that does not rely on toxic reagents and says it would consider licensing it to other stem cell therapy developers on a case-by-case basis.

Thawing market heats up: Biocision expands cell therapy tech offering

29-Jan-2016 By Gareth Macdonald

Biocision has revamped its cell thawing platform to accommodate larger vial sizes and started developing an automated system for cell therapies in cryopreservation bags.

No Zika vaccine before Rio Olympics: Grant funded-development at early stage says US NIAID

28-Jan-2016 By Gareth Macdonald

The US NIAID is supporting development of several experimental Zika vaccines but none will be ready before Brazil, the country at the centre of the current outbreak, hosts the Olympic Games this summer.

Austrianova rolls out cell banking and fill finish services

27-Jan-2016 By Gareth Macdonald

Austrianova has launched cell banking and fill finish services for cell therapy developers at its facility in Singapore.

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.

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.

BASF and Sumitomo team to develop cell lines for tox testing

22-Dec-2015 By Gareth Macdonald

BASF and Sumitomo have teamed up to develop an in vitro alternative to animal-based chemical testing systems.

Sweden to back biomanufacturing through SEK320m investment scheme

18-Dec-2015 By Gareth Macdonald

The Swedish Government has announced a multi-million kronor plan to back biopharmaceutical research and manufacturing in the country.

IPO ready BeiGene adopts GE tech for China cancer biologics plant

16-Dec-2015 By Gareth Macdonald

Nasdaq-bound Chinese biopharma BeiGene has chosen GE Healthcare’s Flexfactory platform for the monoclonal antibody (mAb) plant it is building in Suzhou.

Dengvaxia approval vindicates €350m 'industrial risk' says Sanofi Pasteur

11-Dec-2015 By Gareth Macdonald

Sanofi Pasteur says Mexican approval for Dengvaxia vindicates the ‘industrial risk’ it took when it invested €350m in a dengue fever vaccine plant in 2009.

Making waves: scientists use seaweed to grow stem cells

11-Dec-2015 By Melissa Fassbender

Scientists have identified seaweed as a source of nutrients for the expansion of pluripotent stem cells needed for future drug testing.

FDA approves Alexion's Kanuma made from GE chicken eggs

09-Dec-2015 By Dan Stanton

Alexion’s Kanuma has become the second biological product produced by genetically engineered animals to be approved by the US FDA.

Sandoz sets out Neulasta biosim plan after Ph III data brings US approval a step closer

08-Dec-2015 By Gareth Macdonald

Sandoz has confirmed that plants in Europe and Asia will make its version of Neulasta (pegfilgrastim) for the US market if the drug is approved.

GSK set to kickstart asthma mAb sector after EU Nucala approval

04-Dec-2015 By Gareth Macdonald

Making the newly approved asthma drug Nucala (mepolizumab) involves facilities on both sides of the Atlantic according to GSK, which says it has no plan to outsource production.

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).

New liver cell production method will spark end of animal testing, scientist

02-Dec-2015 By Dan Stanton

An Israeli researcher says a cost-effective method for making human liver cells offers drug developers better safety evaluation and will “undoubtedly” replace animal testing.

Samsung Biologics doubling capacity through third Korean plant

01-Dec-2015 By Dan Stanton

Samsung Biologics has invested $740m to build a third facility in Korea, adding a further 180,000L of mammalian cell culture capacity.

Novo Nordisk licenses 'small antibody' tech from Ablynx

25-Nov-2015 By Dan Stanton

Ablynx has licensed its nanobody platform to Novo Nordisk which hopes to discover and develop single-domain antibody fragment drug candidates.

CRISPR editing gives mosquitoes malaria-resistant DNA

24-Nov-2015 By Fiona BARRY

Scientists trying to curb malaria deaths usually concentrate on preventing mosquito bites or developing human vaccines and therapies, but novel gene-editing tool CRISPR is opening up another path.

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).

Dyadic to sell fungal expression system to DuPont for $75m

18-Nov-2015 By Staff Reporter

Dyadic has agreed to sell its enzyme-producing fungal expression system and the rest of its industrial technology business to DuPont for $75 million (€70 million).

Stemedica takes over Smith & Nephew cell production plant

18-Nov-2015 By Staff Reporter

Stemedica Cell Technologies has expanded its manufacturing operation into Europe by taking over a facility from Smith & Nephew.

Epirus confident to take slice of $3bn infliximab market; completes manufacturing milestone

17-Nov-2015 By Dan Stanton

Epirus is set to file its Remicade biosimilar in 2017 and says the $3bn market will remain a large opportunity despite growing entrants in infliximab development.

New York Stem Cell Foundation teams with CBR to create stem cell lines

11-Nov-2015 By Anthony King

The Cbr Cord Blood Registry and the New York Stem Cell Foundation (NYSCF) are to collaborate on the creation of high-quality stem cell lines.

Animal study shows benefit from gene therapy in late-stage eye disease

06-Nov-2015 By Anthony King

Corrective gene therapies for an inherited eye disease could allow even patients with later stages of the disease to benefit from intervention. 

Takeda taps Univercells for low-cost vaccine technology

04-Nov-2015 By Phil Taylor

Takeda has taken a stake in Belgian bioprocessing start-up Univercells as part of a programme aimed at supplying low-cost vaccines to lower-income countries.

Bioprocess International

‘Beyond revolutionary’: bioreactor-in-a-briefcase brings warzone production

27-Oct-2015 By Fiona BARRY

Soldiers on the battlefield will soon be able to manufacture life-saving biologics in under eight hours using a portable briefcase-sized kit.

Pfizer to hire 130 in Ireland

23-Oct-2015 By Fiona BARRY

Pfizer has announced an extra 90 production jobs at Dublin’s Grange Castle biomanufacturing site, adding to the 40 hires it plans for its API facilities in Cork, Ireland.

Sigma-Aldrich to manufacture Wellcome CRISPR library

20-Oct-2015 By Fiona BARRY

Sigma-Aldrich is partnering with the Wellcome Trust to manufacture and distribute a CRISPR library on behalf of the UK research charity.

Asterias to set up UK arm to access cell therapy production smarts

14-Oct-2015 By Gareth Macdonald

US biotech Asterias Biotherapeutics will set up a UK subsidiary to access Cell Therapy Catapult’s (CTC) process development know-how.

Dispatches from CPhI

Catalent to expand biologics facility to keep up with capacity demand

14-Oct-2015 By Dan Stanton

Catalent says it is contemplating expanding its Wisconsin single-use biologics facility as strong demand from SMEs and biotechs has almost filled current capacity.

Dispatches from CPhI

INN guidance leaves FDA in catch-22 over awaited interchangeability rules, experts

13-Oct-2015 By Dan Stanton

Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.

M+W contracted to build cell therapy facility by UK Government

09-Oct-2015 By Gareth Macdonald

M+W has been contracted to build a £55m ($84m) manufacturing site that will support cell and gene therapy developers by the UK Government project, Cell Therapy Catapult.

Trenzyme licenses 7g per litre expression tech from JRS's Celonic

07-Oct-2015 By Gareth Macdonald

Contractor Trenzyme GmbH has licensed a CHO cell line-based expression system from Swiss firm Celonic AG in a deal designed to expand its service offering.

TPP: Five years data protection for biologics in US-Asia trade deal

05-Oct-2015 By Dan Stanton

Biologic drugs will be given a minimum of five years of data protection under the TPP (Trans-Pacific Partnership) trade deal agreed today, upsetting industry groups which had campaigned for 12.

Round 2 Amgen? US FDA accepts Sandoz's Enbrel biosimilar for review

02-Oct-2015 By Gareth Macdonald

A second Sandoz biosimilar has been accepted for review by US FDA setting the stage for another potential legal battle with Amgen.

Sorrento Therapeutics launches $170m mAB JV for ‘undruggable’ targets

29-Sep-2015 By Fiona BARRY

Oncology company Sorrento Therapeutics has formed an antibody JV in a deal worth over $170m with a Californian research centre.

Lonza's stem cell production insight a boon to innovation and business

28-Sep-2015 By Dan Stanton

Investments in manufacturing and science have left Lonza well placed to cope with skyrocketing demand for stem cell manufacturing, the CMO says.

Lonza paper reveals secrets behind cGMP stem cell production

25-Sep-2015 By Dan Stanton

Lonza has published a guide to clinical-grade induced pluripotent stem cell (IPSC) manufacture, addressing concerns around the derivation of cellular materials.