European Pharmaceutical Review

OCTOBER 5, 2023

Ahead of her presentation on the future of biomanufacturing at CPHI Barcelona, Sheila Ann Mikhail, the co-founder and former CEO of AskBio, engages in a conversation about gene therapy, artificial intelligence, and the importance of being a well-informed innovator when selecting a manufacturing partner. at Conference Centre 4.

Manufacturing 86

Manufacturing Consulting Patients Marketing 86

Pharmaceutical Technology

NOVEMBER 16, 2022

ElevateBio has entered a partnership with Affini-T Therapeutics to progress the latter’s engineered TCR-T therapies focused on Kirsten rat sarcoma viral oncogene homolog (KRAS), a dominant oncogenic driver mutation in solid tumours. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Engineering 98

Engineering Manufacturing Pharmaceutical Patients 98

Pharmaceutical Technology

APRIL 3, 2023

The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. Polyplus, based in Strasbourg, France, produces key components in the production of viral vectors used in cell and gene therapies.

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Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company is also committed to establishing mRNA manufacturing facilities in Australia, Canada, the US and the UK. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme.

Manufacturing 115

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Pharmaceutical Technology

JUNE 8, 2023

DTx-1252 is a fatty acid ligand conjugated oligonucleotides (FALCON) small interfering RNA (siRNA) therapeutic which represses the PMP22 gene in Schwann cells. FALCON siRNAs can be manufactured at low cost and delivered intrathecally [via the spine], intravenously and subcutaneously.

Food and Drug Administration 98

Food and Drug Administration FDA Food Manufacturing 98

Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

Food and Drug Administration 97

Food and Drug Administration Manufacturing Engineering Food 97

Pharmaceutical Technology

DECEMBER 21, 2022

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Free Whitepaper. By Cytiva Thematic.

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Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.

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Pharmaceutical Technology

JUNE 1, 2023

The funding is being provided under the agency’s Transforming Medicines Manufacturing programme. This unique collaboration can provide the industry with unparalleled access to cutting-edge technologies to accelerate drug design, development, characterisation, and manufacture.

Medicine 97

Medicine Side effects Manufacturing Leads 97

Pharmaceutical Technology

DECEMBER 8, 2022

Kite Pharma and Daiichi Sankyo have updated a partnership agreement signed in 2017 for the former’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Free Whitepaper. By Cytiva Thematic.

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Manufacturing Marketing Engineering Patients 122

Pharmaceutical Technology

JULY 12, 2022

ViaCyte focuses on offering new stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D). VX-880 is an investigational allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell therapy of Vertex for T1D. Topic sponsors are not involved in the creation of editorial content.

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Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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Pharmaceutical Technology

OCTOBER 14, 2022

Pharmaceutical companies Xcell Biosciences (Xcellbio) and aCGT Vector have partnered to expedite the development of cell and gene therapies. The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients.

Manufacturing 52

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Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. The core objective of the collaboration is to make the therapies affordable and accessible to patients.

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European Pharmaceutical Review

JULY 20, 2023

As proven by recent regulatory approvals sweeping the cell and gene therapy industry, particularly within Europe and the US, these pioneering treatments have demonstrated great capacity in helping to resolve hard-to-treat diseases. Batty discussed some of the capabilities of haemophilia gene therapies in 2023.

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Pharmaceutical Technology

DECEMBER 14, 2022

Merck and Synplogen have signed a non-binding Memorandum of Understanding (MoU) to expedite the development and manufacturing of viral vector-based gene therapy applications. The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan.

Manufacturing 52

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Pharmaceutical Technology

JUNE 2, 2023

Rentschler Biopharma has collaborated with Ikarovec for expediting the new gene therapies to treat ophthalmic disease. The company is developing new and differentiated gene therapies for the treatment of serious, but common eye diseases. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Biopharma 52

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Pharmaceutical Technology

AUGUST 22, 2022

Porton Advanced Solutions has raised $80m in a Series B funding round to expand its end-to-end gene and cell therapy (GCT) contract development and manufacturing organisation (CDMO) platforms. These expansions could aid the company in becoming a worldwide end-to-end GCT CDMO platform to help bring new therapies to patients.

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Pharmaceutical Technology

NOVEMBER 29, 2022

Neogene focuses on discovering, developing and producing next-generation T-cell receptor therapies (TCR-Ts) that provide a new cell therapy approach for fighting cancer. TCR-Ts can detect intracellular targets such as cancer-specific mutations to unlock targets which were not accessible earlier using cell therapies.

Manufacturing 111

Manufacturing Leads Patients Pharmaceutical 111

Pharmaceutical Technology

JUNE 9, 2023

KateTx will receive an undisclosed upfront payment from Astellas for an exclusive global licence to develop, manufacture and commercialise KT430. KT430 is a preclinical, next-generation investigational gene therapy designed for the treatment of X-linked myotubular myopathy (XLMTM), a rare and life-threatening neuromuscular disease.

Pharma 59

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Pharmaceutical Technology

MAY 17, 2023

AGC Biologics has introduced the BravoAAV and ProntoLVV viral vector platforms that offer quick clinical and commercial production and release of good manufacturing practices (GMP). Both platforms use the company’s development, manufacturing and analytical capabilities in lentiviral vector (LVV) and adeno-associated viral vector (AAV).

Manufacturing 52

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Pharmaceutical Technology

DECEMBER 12, 2022

Gilead company Kite has entered an international strategic partnership with Arcellx for the joint development and commercialisation of the latter’s T-cell therapy, CART-ddBCMA, to treat relapsed or refractory multiple myeloma patients. Kite will carry out the manufacturing following the technical transfer. Free Whitepaper.

Manufacturing 105

Manufacturing Marketing Pharmaceutical Patients 105

Pharmaceutical Technology

JUNE 8, 2023

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.

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Manufacturing Leads Patients Medicine 52

Pharmaceutical Technology

NOVEMBER 9, 2022

On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies. Known by the brand name Roctavian, BioMarin’s haemophilia A therapy valoctocogene roxaparvovec could be fairly priced in the range of $1.95–1.96

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Pharmaceutical Technology

AUGUST 26, 2022

ElevateBio has signed a long-term strategic collaboration with the University of Pittsburgh, US, to establish a biomanufacturing centre for expediting cell and gene therapy development. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

MAY 2, 2023

Marker Therapeutics has reached a non-dilutive agreement to sell cell manufacturing assets to CellReady for $19m in cash. CellReady is a newly created contract development and manufacturing organisation (CDMO) founded by Marker board member and co-founder John Wilson. Both firms expect to complete the deal on 26 June 2023.

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Pharmaceutical Technology

APRIL 6, 2023

Ginkgo Bioworks has strengthened its end-to-end R&D capabilities in gene therapy with the purchase of adeno-associated virus (AAV) capsid discovery and engineering assets from StrideBio, for an undisclosed sum. The new capabilities and IP will be incorporated under Ginkgo’s end-to-end AAV gene therapy development platform.

Engineering 52

Engineering Safety Manufacturing Leads 52

Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

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Pharmaceutical Technology

AUGUST 25, 2022

Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. A cGMP-compliant production facility will be housed at the centre for manufacturing cell products at scale.

Manufacturing 52

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Pharmaceutical Technology

APRIL 27, 2023

Bristol Myers Squibb will take over a former Novartis plant to boost viral vector production for chimeric antigen receptor (CAR) T-cell therapies. Bristol Myers Squibb stated that the facility will provide viral vector production capabilities for its two CAR T-cell therapies.

Engineering 52

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Pharmaceutical Technology

APRIL 5, 2023

Caribou Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its CAR-T cell therapy, CB-011. The therapy is currently under development for the treatment of patients with relapsed or refractory multiple myeloma (r/r MM). Topic sponsors are not involved in the creation of editorial content.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Food 59

Pharmaceutical Technology

JUNE 12, 2023

Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Engineering Manufacturing Leads Sales 52

Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

Manufacturing 52

Manufacturing Pharmaceutical Medicine Management 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna has entered a strategic research and development partnership with ElevateBio’s Life Edit Therapeutics to discover and develop new in-vivo mRNA gene editing therapies. Moderna will also assume further development, manufacturing, and commercialisation responsibilities on exercising a target option.

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Pharmaceutical Technology

MAY 1, 2023

The grant will help in expediting pre-clinical and manufacturing activities of the product. According to Ossium Health, nearly 30 to 60% allogeneic HCT recipients develop acute GVHD and approximately half of them will become refractory to systemic steroid therapy. Topic sponsors are not involved in the creation of editorial content.

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Food and Drug Administration Food Manufacturing Medicine 64

Pharmaceutical Technology

MAY 31, 2023

million) in an equity financing round that will be used to move the company’s cell therapy candidates into the clinic in 2024, based on a 31 May press release. The funding will also be used to work on Anocca’s cell therapy discovery and manufacturing process. Topic sponsors are not involved in the creation of editorial content.

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