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Hot Topics > Cell & Gene Therapies

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.

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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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