Flash BioSolutions welcomes Stewart Craig to its esteemed Scientific Advisory Board

We are thrilled to announce the newest addition to our esteemed Scientific Advisory Board at Flash BioSolutions! Join us in welcoming Stewart Craig, a titan in the biotech industry, with over four decades of invaluable experience.

Toulouse, France, 30 April 2024 – Flash BioSolutions, a renowned Contract Development and Manufacturing Organization (CDMO) specializing in gene delivery, proudly announces the addition of Stewart Craig to its distinguished Scientific Advisory Board.

With four decades of experience in the biotechnology industry, Stewart Craig brings a wealth of expertise and leadership to his new role. For the past 30 years, Stewart has held executive positions focusing on the strategic development, implementation, and oversight of Chemistry, Manufacturing, and Controls (CMC), Technical Operations and Good Manufacturing Practice (GMP) infrastructures for cutting-edge cell and gene therapy enterprises.

Stewart’s journey in biotechnology has been marked by significant contributions to the field as he has played pivotal roles in spearheading the development, manufacturing, and clinical delivery of a diverse portfolio of biologics, including recombinant proteins, antibodies, cell therapies, viral vectors and gene-modified cell products. His expertise extends beyond operational realms, encompassing adept management of regulatory affairs across international jurisdictions, including the US, Canada, Switzerland, and Europe.

As the Co-founder and Principal Consultant at Broken Lance Biotech Consulting, Stewart Craig continues to be a guiding force within the biotech sector. His previous roles as Chief Technical Officer at jCyte, Inc. and Erytech Pharma, along with his tenure as Chief Manufacturing Officer at Orchard Therapeutics Ltd., Chief Operating Officer at Xcytye Therapies, Inc. and Senior Vice President of Technical Operations at Sangamo BioSciences, underscore his invaluable contributions to advancing innovative products into patient treatments.

“We are thrilled to welcome Stewart Craig to our Scientific Advisory Board,” expressed Jérôme Bédier, CEO of Flash BioSolutions. “His extensive experience and profound understanding of biotechnology will undoubtedly enrich our endeavors as we strive to pioneer transformative treatments for patients worldwide. Stewart’s participation will offer invaluable expertise to support the process validation needed to ensure the highest quality standards for our customers, particularly for our LentiCare® and FlashRNA® platforms.”

Stewart Craig added: “Joining the Scientific Advisory Board of Flash BioSolutions represents an exciting opportunity for me to contribute to the development of this innovator company within the CDMO sphere. I am deeply convinced that the future of biotechnology lies in dynamic collaborations between key players in the industry. Flash BioSolutions embodies this spirit of innovation and commitment to scientific excellence and quality in gene therapy. I’m driven by the desire to share my expertise and knowledge to help the company reach new heights in the manufacture and development of revolutionary treatments. Together, we can create a significant impact on patients’ lives and shape the future of medicine.”

As a distinguished member of Flash BioSolutions’s Scientific Advisory Board, Stewart Craig will provide invaluable strategic guidance and scientific acumen, further propelling the company’s mission to revolutionize gene therapy.

Flash BioSolutions

About Flash BioSolutions:

Flash BioSolutions® is a preeminent CDMO specializing in the industrial-scale production of DNA and RNA vectors for clientele within the domains of gene and cell therapy, and vaccine development. Bolstered by a robust manufacturing platform and validated processes honed over two decades, Flash BioSolutions® excels in delivering vectors of unmatched purity and concentration across research, pre-clinical, clinical, and commercial phases.

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Collaboration between CEA and FLASH Biosolutions for the development of cutaneous cell therapy

Flash Therapeutics celebrates a decade of collaboration with the prestigious CEA’s LGRK, bolstering skin stem cell research. This partnership underscores Flash’s commitment to pioneering advanced therapies. Exciting discussions for further collaboration are underway, marking a pivotal moment in advancing innovative solutions for healthcare.

Toulouse – Paris, France, 
February 5th, 2024

Toulouse – Paris, France, February 5th, 2024 – Flash Therapeutics, a French CDMO specialized in the bioproduction of viral vectors for the transfer of genetic material, is extremely proud to count the CEA, in particular, l’Institut de biologie François Jacob – Laboratoire de Génomique et Radiobiologie de la Kératinopoïèse – LGRK, among its major customers.

Thanks to the quality of Flash Therapeutics’ vectors, the LGRK has been sourcing specific products from our company for over 10 years to support its research activities, in particular, to study the intrinsic properties and regenerative capacity of skin stem cells. The CEA has published an excellent article on epidermal stem cells entitled ” KLF4 inhibition promotes the expansion of keratinocyte precursors from adult human skin and of embryonic-stem-cell-derived keratinocytes ” (1) in Nature Biomed Engineering by Nicolas Fortunel & al.

Flash Therapeutics and the CEA’s Institut de biologie François Jacob are currently discussing expanding their partnership, given their complementary nature.

About the CEA:

The CEA’s role is to inform public decision-making by providing scientific and technological solutions to the driving forces (companies, local authorities), to better manage major societal changes: energy transition, digital, healthcare of the future, global defence and security. Its 21,000 employees work at the heart of 9 centres equipped with major research infrastructures, as part of academic and industrial partnerships in France, Europe and internationally.

The Institut de biologie François Jacob (CEA-Jacob), based at the CEA-Paris-Saclay sites in Fontenay-aux-Roses, Evry and the Hôpital Saint Louis in Paris, conducts research in radiobiology and radiotoxicology, human health (neurodegenerative, infectious, and immuno-haematological diseases) and medical and environmental genomics. Within CEA-Jacob, the Laboratory of Genomics and Radiobiology of Keratinopoiesis (LGRK) uses the skin as a biological model to study stem cells from human adult organs and tissues. Their research consists in exploring the intrinsic properties and regenerative capacity of these cells, as well as skin disorders linked to exposure to ionising radiation.

About Flash Biosolutions:

Founded in 2005 and based at the Oncopole site in Toulouse, Flash Therapeutics is a CDMO specialized in the industrial bioproduction of DNA and RNA vectors to cover a wide range of applications in gene and cell therapy and vaccines. Thanks to its robust platform and manufacturing process, Flash Therapeutics delivers high-purity, high-concentration viral vectors for research, pre-clinical, clinical and commercial phases.

(1) Fortunel, N.O., Chadli, L., Coutier, J. & al. KLF4 inhibition promotes the expansion of keratinocyte precursors from adult human skin and of embryonic-stem-cell-derived keratinocytes. Nat Biomed Eng 3, 985–997 (2019). https://doi.org/10.1038/s41551-019-0464-6

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Flash BioSolutions celebrates a decade of collaboration with the prestigious CEA’s LGRK, bolstering skin stem cell research.

KiraGen Bio and Flash BioSolutions Announce Innovative Partnership to Revolutionize CAR-T Therapies for Solid Tumors

KiraGen Bio and Flash BioSolutions join forces to exploit the full potential of CAR-T therapies for solid tumors.

Boston, USA, April 2, 2024 – KiraGen Bio, a pioneering biotech company in the field of innovative cellular therapies for solid tumors, is pleased to announce today a strategic partnership with Flash BioSolutions, a leading CDMO providing state-of-the-art lentiviral particles. This collaboration aims to fully harness the potential of CAR-T (Chimeric Antigen Receptor T-cell) therapies in cancer treatment.

Through this alliance, KiraGen Bio will leverage the advanced expertise of Flash BioSolutions and its flagship technology, LentiCare®. This cutting-edge lentiviral platform will be seamlessly integrated into the development of KiraGen Bio’s groundbreaking CAR-T therapies, playing a crucial role in the Proof of Concept stage and beyond.

The revolutionary aspect of this partnership lies in the synergistic combination of KiraGen Bio’s proprietary AI-driven platform, KiraLOGIC, and Flash BioSolutions’ state-of-the-art LentiCare® technology. KiraLOGIC employs advanced machine learning algorithms to rationally design CAR-T cells equipped with a combination of highly multiplexed gene edits, rendering them resistant to the immunosuppressive tumor microenvironment. By integrating these AI-powered gene editing capabilities with the high-quality lentiviral vectors provided by Flash BioSolutions, KiraGen Bio is poised to unlock the full potential of CAR-T therapies for solid tumors, addressing a critical unmet need in cancer treatment.

“Our KiraLOGIC platform leverages AI to rationally design CAR-T cells resistant to immunosuppression, unlocking the potential of cell therapies for solid tumors. Partnering with Flash BioSolutions, a leader in lentiviral vector manufacturing, is pivotal in advancing our multiplex gene-edited CAR-T therapies. Their LentiCare® technology ensures high-quality lentiviral vectors, essential for generating robust preclinical data and propelling our therapies towards clinical development. Together, we are poised to accelerate scientific progress and deliver transformative treatments to patients in need,” stated Ryan Murray, PhD, CSO & Co-Founder of KiraGen Bio.

“At KiraGen, our unwavering commitment is to bring our revolutionary TME-Guard technology to patients as quickly and broadly as possible. Collaborating with Flash BioSolutions is a significant milestone in realizing this vision. Their deep expertise in lentiviral manufacturing will be instrumental as we rapidly advance our innovative cell therapies through preclinical development and into the clinic. This strategic partnership is key to accelerating our lead programs, forging powerful industry and academic alliances, and building a robust and sustainable pipeline. By joining forces with Flash BioSolutions, we are creating a powerful model that can drive transformative impact for patients while generating value for our investors, as we work to establish KiraGen as a pioneer in solid tumor cell therapy,” added Aaron Edwards, CEO & Co-Founder of KiraGen Bio.

“Flash BioSolutions is thrilled to collaborate with KiraGen Bio in reshaping the paradigm of CAR-T therapies for solid tumors,” stated Jérôme Bédier, CEO of Flash BioSolutions. “Through the potent fusion of our expertise and state-of-the-art technologies, we are steadfast in our commitment to propelling scientific innovation and introducing revolutionary treatment options for patients confronting this formidable disease.”

This partnership between Flash BioSolutions and KiraGen Bio embodies the commitment of both companies to push the boundaries of research to improve the lives of cancer patients. Together, they aspire to open new perspectives in the treatment of solid tumors and bring renewed hope to those battling this disease.

About KiraGen Bio:

KiraGen Bio is a Boston-based biotechnology company pioneering the development of AI-driven, multiplex gene-edited CAR-T cell therapies for solid tumors. By leveraging its proprietary KiraLOGIC platform, KiraGen Bio engineers CAR-T cells with up to 8 tumor microenvironment (TME) resistance gene edits, directly targeting the root cause of immunosuppression. Co-founded by experts from bluebird bio, Beam Therapeutics, and Harvard Business School, KiraGen Bio is committed to pushing the boundaries of science to bring the curative potential of cell therapies to the 90% of cancer patients currently underserved by CAR-T.

Flash BioSolutions

About Flash BioSolutions:

Flash BioSolutions is a CDMO specialized in the industrial production of DNA or RNA vectors for clients in gene and cell therapies, and vaccines. Flash BioSolutions has a robust platform and manufacturing process, proven over 20 years, enabling the delivery of high-purity and high-concentration vectors for research, preclinical, clinical, and commercial phases.

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Soraya Sandokchi
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Introducing Flash BioSolutions : Spearheading advancements in Biopharmaceutical CDMO sector

Flash BioSolutions® strengthens its position in the Contract Development and Manufacturing Organisation (CDMO) market in the biopharmaceutical sector with a dynamic rebranding.

Toulouse, 28 march 2024 – Flash Therapeutics proudly unveils its transformation into Flash BioSolutions®marking a strategic shift aimed at propelling its dominance in the competitive biopharmaceutical Contract Development and Manufacturing Organization (CDMO) landscape.

This rebranding effort is accompanied by the introduction of a dynamic visual identity, emblematic of its relentless pursuit of innovation and its stature as a premier provider of bespoke development and manufacturing solutions in the realm of gene delivery for cell and gene therapy, and immunization.

The decision to reemerge as Flash BioSolutions® signifies a pivotal juncture in the company’s journey, signifying its unwavering resolve to fortify its foothold in the global pharmaceutical outsourcing arena as an indomitable force.

“Our transition to Flash BioSolutions® epitomizes a pivotal evolutionary stride for our enterprise,” declares Jérôme Bédier, the CEO of Flash BioSolutions®. “Our rebranded identity and revitalized visual representation epitomize our steadfast commitment to excellence, operational prowess, and groundbreaking innovation. We take immense pride in our legacy as trailblazers in gene delivery for cell and gene therapy and vaccination, and eagerly anticipate furnishing our clientele with avant-garde solutions to cater to their burgeoning demands.”

The revamped visual identity of Flash BioSolutions® embodies a contemporary industrial aesthetic, emblematic of the company’s resilience, vigor, and pledge to deliver unrivaled quality and innovation. A comprehensive overhaul of the website, slated for launch on July 1, will culminate the identity revamp initiative, enhancing the sales outreach strategies.

Under the distinguished banner of Flash BioSolutions®, the company remains steadfast in its commitment to furnishing cutting-edge development and contract manufacturing services for DNA and RNA gene delivery. This rebranding endeavor aligns seamlessly with the company’s trajectory of expansion and global outreach to meet the escalating market exigencies.

Flash BioSolutions

About Flash BioSolutions:

Flash BioSolutions® is a preeminent CDMO specializing in the industrial-scale production of DNA and RNA vectors for clientele within the domains of gene and cell therapy, and vaccine development. Bolstered by a robust manufacturing platform and validated processes honed over two decades, Flash BioSolutions® excels in delivering vectors of unmatched purity and concentration across research, pre-clinical, clinical, and commercial phases.

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Soraya Sandokchi
+33 582 955 546

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Flash BioSolutions® strengthens its position in the Contract Development and Manufacturing Organisation (CDMO) market in the biopharmaceutical sector with a dynamic rebranding.

Flash BioSolutions obtains Pharmaceutical Establishment status, opening up new avenues for its revolutionary FlashRNA® technology

The company’s recent achievement highlights their dedication to delivering high-quality innovative therapies. They are particularly proud of their revolutionary RNA technology, which has the potential to greatly impact the treatment of severe or genetic diseases and vaccines.

Toulouse, France, 5 March2024 – Flash BioSolutions, a biopharmaceutical development and manufacturing company (CDMO), is proud to announce that it has been certified Pharmaceutical Establishment status by the French National Agency for the Safety of Medicines (ANSM). This status recognises Flash BioSolutions’ commitment to the highest manufacturing standards in the biomanufacturing of vectors for injectable pharmaceutical products.

This Pharmaceutical Establishment status provides Flash BioSolutions with additional regulatory authority and strengthens its ability to develop and deliver high quality products to its partners and customers. This step underlines Flash BioSolutions’ commitment to innovation and excellence.

One of Flash BioSolutions’ two flagship technologies, FlashRNA®, is a revolutionary RNA technology. Designed to be injected directly into humans, FlashRNA® opens up new perspectives in the treatment of genetic diseases, vaccines, cancers and other serious conditions. FlashRNA® technology promises to be an effective and innovative solution to major unmet medical needs.

« We are extremely proud to receive Pharmaceutical Establishment status » said CEO Jérôme Bédier. « This achievement demonstrates our commitment to excellence and reinforces our determination to deliver breakthrough therapies that could be game changers for our customers in the treatment of serious diseases. We look forward to working with our partners to realise the full potential of this FlashRNA® technology, which will be injected into humans as early as 2025. »

« We are convinced that this certification will reinforce our customers’ confidence in our ability to provide high-quality biomanufacturing solutions » added Virginie Jassin, Quality Director. « We would like to thank all our employees for their investment. Their collaboration has been essential in reaching this important milestone in the life of the company. »

Flash BioSolutions

About Flash BioSolutions:

Created in 2005 and based at the Oncopole site in Toulouse, Flash BioSolutions is the commercial brand name of Flash Therapeutics, a CDMO specialising in the industrial production of DNA or RNA vectors for clients in gene and cell therapy and vaccines. Flash BioSolutions has a robust platform and manufacturing process enabling it to deliver high-purity, high-concentration viral vectors for the research, pre-clinical, clinical and commercial phases.

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Soraya Sandokchi
+33 582 955 546

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