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Cell & Gene Therapies

Cell & Gene Therapies

Relatively few have reached approval stage but the clinical space is filling up with autologous and allogeneic cellular therapies in which intact, living cells are injected into a patient. Similarly industry is developing therapies which consist of the introduction of normal genes into cells in place of missing or defective ones in order to correct genetic disorders.


US FDA stem cell enforcement challenged by state legislation

20-Sep-2017 - State legislation allowing unapproved stem cell treatments could undermine efforts by the US FDA to clampdown on unregistered clinics.

Synpromics expansion to support growing gene control business

19-Sep-2017 - Moving to a larger facility will help Scottish firm Synpromics Ltd increase its gene control and cell line services presence, the firm says.

GE launches cell therapy thawing tech

06-Sep-2017 - GE Healthcare has launched a thawing technology for cell therapies it says removes the risks and inconsistencies of standard water baths.

Dude where’s my CAR-T? Personalised meds need personalised logistics, says TrakCel

01-Sep-2017 - After receiving approval Kymriah, Novartis must prove it can handle the supply chain complexities of manufacturing high-value and time-sensitive CAR-T cell therapies, says logistics firm TrakCel.

Gilead aims to expand CAR-T manufacturing capabilities post-Kite acquisition

01-Sep-2017 - Gilead says it is committed to driving down costs of CAR-T manufacturing after agreeing to buy late-stage cell and gene therapy firm KitePharma for $11.9bn.

Oxford BioMedica could pocket $100m on Novartis CAR-T cell success

31-Aug-2017 - Oxford BioMedica saw its share price jump 21% after the US FDA approved Kymriah, the gene modified cell therapy made with the firm’s lentiviral vectors.

‘A new frontier:’ US FDA approves Novartis’ $475,000 CAR-T cell cancer therapy

31-Aug-2017 - Kymriah (tisagenlecleucel), made at the former-Dendreon site in New Jersey, has become the first gene modified cell therapy to be approved in the US.

CSL adding scalable stem cell gene therapy tech in $91m Calimmune buy

30-Aug-2017 - CSL Behring will launch itself into the stem cell gene therapy through the acquisition of Calimmune, adding a preclinical candidate and two manufacturing efficiency technologies.

US FDA steps up enforcement against unscrupulous stem cell firms

29-Aug-2017 - The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell...

Being for the $11.9bn benefit of investors of Kite: Gilead jumps into CAR-T

28-Aug-2017 - Gilead will add a late-stage CAR T-cell candidate and a facility in California capable of treating 5,000 patients per year through the $11.9bn deal.

ACF bioanalytical plant opens as cell and gene therapies reach ‘tipping point’

24-Aug-2017 - ACF Bioservices has completed the construction of its Exton, Pennsylvania, US-based facility for cell and gene product testing.

Kite assesses EU manufacturing options as it submits CAR-T therapy for review

04-Aug-2017 - Kite Pharma has submitted the first CAR-T candidate axicabtagene ciloleucel to the EMA for review and says it is evaluating manufacturing options in Europe.

Alexion ends Moderna mRNA pact

28-Jul-2017 - Alexion Pharmaceuticals says it is reducing R&D operations and terminating mRNA-focused preclinical partnerships.

Dispatches from BioPharma Expo, Japan

Lonza expands in Asia: 8,000L single-use in Singapore, regenerative meds in Japan

30-Jun-2017 - Lonza will install four 2,000L single-use bioreactors at its Singapore facility to cater for growing demand for small to mid-volume biologics production.

Takeda prepping to take over EU production of stem cell therapy from 2021

23-Jun-2017 - Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohn’s disease stem cell therapy licensed from TiGenix.

Cell Medica buys T cell receptor cancer candidate from UK Catapult

20-Jun-2017 - Cell Medica says it will work with the Cell and Gene Therapy Catapult to assess automation and processing technologies involved in scaling-up the acquired cancer candidate.

Lonza plugs EU cell and gene therapy manufacturing gap through PharmaCell buy

09-Jun-2017 - The acquisition of Dutch commercial cell and gene therapy maker PharmaCell places Lonza as the leading CDMO in the space, the firm says.

T Cell vaccine maker TapImmune looks to monetise expression tech

07-Jun-2017 - TapImmune says it is exploring licensing out its nucleic acid-based protein expression technology PolyStart to vaccine developers.

Orchard Therapeutics hits up Hitachi CDMO to make autologous gene therapy

06-Jun-2017 - Hitachi Group subsidiary PCT Cell Therapy Services will provide clinical manufacturing services for Orchard’s autologous gene therapy for the treatment of adenosine deaminase deficiency.

A happy medium for stem cells? Irvine Scientific launches GMP xeno-free offering

17-May-2017 - Xeno-free and cGMP-manufactured media are highly desired by cell therapy developers, says Irvine Scientific as it launches a medium for hematopoietic stem and progenitor cells (HSPCs).

Pfizer expands hemophilia gene therapy pipeline with $720m Sangamo deal

12-May-2017 - Pfizer has upped its presence in the gene therapy space through collaboration with Sangamo Therapeutics on its programmes worth up to $720m.

Juno hopes to make T Cells in two days using reagents and automation tech

05-May-2017 - Juno says it is working on a set of technologies which will be able to manufacture Chimeric Antigen Receptor (CAR) T Cells within two days.

News in brief

Synpromics announces £5.2M British investment in gene therapy tech

19-Apr-2017 - 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 - 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.

GE aiming to be cell therapy production services one-stop-shop

12-Apr-2017 - GE Healthcare has acquired cryopreservation technology firm Asymptote and says more investments are likely as it builds an “end-to-end ecosystem” for cellular therapy production services.

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