- Forge’s FUEL™ platform and manufacturing services support the production of AAV for EPI-321, Epicrispr’s investigational gene therapy for FSHD
- Material manufactured at Forge for Epicrispr is being used in a clinical trial across the U.S., New Zealand, and Australia, adding to Forge’s experience in supporting clinical programs in APAC
SAN FRANCISCO, CA and COLUMBUS, OH – May 5, 2026 – Epicrispr Biotechnologies (“Epicrispr”), a clinical-stage company pioneering gene-modulating therapies, and Forge Biologics (“Forge”), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced a strategic partnership to support the development and manufacturing of EPI-321, Epicrispr’s investigational AAV gene therapy for facioscapulohumeral muscular dystrophy (FSHD).
Through this collaboration, Forge is providing Epicrispr with AAV process development, current Good Manufacturing Practices (cGMP) manufacturing, and analytical development services. Epicrispr is also leveraging Forge’s proprietary FUEL™ platform, including its HEK293 suspension Ignition Cells™, pEMBR™ 2.0 adenovirus helper plasmid, and optimized AAVrh74 rep/cap plasmid. All manufacturing activities occur at the Hearth, Forge’s 200,000-square-foot facility in Columbus, Ohio.
Material manufactured at Forge for Epicrispr is being used in evaluating EPI-321 in a first-in-human FSHD clinical trial across the U.S., New Zealand, and Australia, adding to Forge’s experience in supporting clinical programs in the Asia-Pacific (APAC) region.
“FUEL™ was designed to enable more efficient manufacturing, delivering more doses per run so partners like Epicrispr can reach more patients,” said David Dismuke, Ph.D., Chief Technical Officer at Forge Biologics. “As an early development partner of our FUEL™ platform, we’re proud to help advance EPI-321 and enable the scalable delivery of a potentially transformative, curative therapy for patients with FSHD.”
EPI-321 is an investigational, single-dose gene-modulating therapy designed to silence aberrant DUX4 expression in skeletal muscle, which drives progressive muscle degeneration in patients with FSHD. Delivered intravenously via a clinically validated AAV vector, it has demonstrated robust DUX4 suppression and protection of muscle tissue in preclinical models. Material produced at Forge demonstrates high purity and consistent quality, with optimized capsid composition. Early clinical data from the ongoing first-in-human study demonstrate that EPI-321 is well tolerated, with no serious adverse events reported to date.
“EPI-321 represents a potential first-and best-in-class therapy for FSHD by addressing the root cause of disease through epigenetic regulation,” said Amber Salzman, Ph.D., Chief Executive Officer, Epicrispr Biotechnologies. “Our partnership with Forge strengthens our ability to scale manufacturing as we generate additional clinical data showing early signs of improved muscle function and increased muscle volume following a single dose. We believe these data support the potential for a durable, one-time therapy for patients with this devastating disease.”
About EPI-321
Patients have shown encouraging signals of biological activity and clinical benefit, including improvements across a broad range of strength and functional measures, increases in lean muscle mass as measured by whole-body MRI, and reductions in circulating DUX4 biomarkers. At six months post-treatment, treated patients demonstrated measurable gains in muscle mass compared to baseline, contrasting with declines typically observed in natural history and external control datasets. EPI-321 has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration. Epicrispr is advancing a broader pipeline of epigenetic editing therapies through its proprietary Gene Expression Modulation System (GEMS) platform, designed to precisely regulate any gene without permanently altering DNA, with applications across neuromuscular and ophthalmic diseases.
About Epicrispr Biotechnologies
Epicrispr Biotechnologies is a biotechnology company pioneering gene-modulating therapies, leading with treatments for neuromuscular diseases. The company’s proprietary Gene Expression Modulation System (GEMS) enables precise and durable control of gene expression, unlocking first-in-class treatments for previously untreatable conditions. Epicrispr’s lead program, EPI-321 is in clinical trials for FSHD, and the company is advancing additional gene-modulating therapies. Learn more at www.epicrispr.com.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Media Inquiries
Epicrispr Biotechnologies:
Kimberly Ha
KKH Advisors
kimberly.ha@kkhadvisors.com
Forge Biologics:
Media
Marina Corleto
Associate Director, Marketing & Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian
Senior Vice President, Client Development
CD@forgebiologics.com
- Partnership marks a critical step toward clinical development of an AAV gene therapy using a base editing approach designed to target theapproach designed to target the genetic cause of Hutchinson-Gilford Progeria Syndrome
- Forge Biologics will provide process development and manufacturing expertise to support gene therapy advancement led by world-renowned researchers Leslie Gordon, David Liu, and Francis Collins
PEABODY, MA and COLUMBUS, Ohio – March 3, 2026 – The Progeria Research Foundation (“PRF”), a nonprofit research organization dedicated to developing treatments and the cure for Hutchinson-Gilford Progeria Syndrome (“Progeria”), and Forge Biologics, (“Forge”), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced a manufacturing agreement to support the development and manufacturing of SamPro-2, PRF’s investigational gene therapy for children and young adults living with Progeria, an ultrarare and fatal genetic disease characterized by rapid aging.
The manufacturing agreement brings together PRF’s decades-long, research-driven Progeria program with Forge’s integrated gene therapy capabilities including process development, cGMP manufacturing, FUEL™ platform technologies, and regulatory consultation. Forge will provide manufacturing services for Investigative New Drug (IND)-enabling studies with SamPro-2, a gene therapy that uses adeno-associated virus (AAV), a commonly utilized delivery vehicle in gene therapy, to deliver a base editing approach designed to correct the single DNA base mutation in the lamin A gene that causes Progeria.
“The era of Progeria gene therapy has arrived. Our hope is that SamPro-2 will give children and young adults with Progeria the longer, healthier lives they deserve,” said Leslie Gordon, M.D., Ph.D., co-founder and medical director of PRF and the mother of Sam Berns who had Progeria. “We are extremely grateful to be working with Forge Biologics, whose manufacturing expertise is essential to move this work from the laboratory towards clinical trials.”
PRF and its collaborators, collectively known as the Progeria Gene Team, have created SamPro-2, a CRISPR-based gene editing strategy designed to permanently correct the Progeria genetic mutation at its source. The effort is led by Dr. Gordon, a leading Progeria expert and clinical trialist; David R. Liu, Ph.D., Richard Merkin Professor and Director of the Merkin Institute for Transformative Technologies in Healthcare at the Broad Institute of MIT and Harvard, whose laboratory has been an international leader in the development of base editing technology; Francis S. Collins, M.D., Ph.D., Senior Research Advisor to the Progeria Research Foundation; and the late Sammy Basso, M.S., former scientist, advocate, and enduring inspiration whose legacy continues to guide this work.
“Behind every program like this are patients and families who have waited a long time for progress,” said John Maslowski, president and chief executive officer of Forge Biologics. “The Progeria Research Foundation and its Gene Team have shown extraordinary dedication to advancing this science, and we are honored to partner with them. At Forge, we bring that same level of care, expertise, and technical rigor to our manufacturing work as we help advance this program for patients.”
About SamPro-2
SamPro-2 is an investigational in vivo gene-editing therapy being advanced by The Progeria Research Foundation (PRF) as part of its Path to Cure Progeria initiative. SamPro-2 is designed to correct the underlying genetic cause of Hutchinson-Gilford Progeria Syndrome (Progeria) using precision base-editing technology, packaged in an AAV9 capsid, to correct the single DNA letter change that leads to production of the toxic protein progerin.
About The Progeria Research Foundation
The Progeria Research Foundation (PRF) is the driving force behind the global effort to understand, treat and ultimately cure Hutchinson-Gilford Progeria Syndrome (Progeria), a rare and fatal genetic disease that causes rapid aging in children. Founded by the family of Sam Berns after his diagnosis in 1999, PRF has enabled or led every major scientific breakthrough in the field, from discovery of the gene that causes the disease to the first FDA-approved treatment, lonafarnib, to the advancement of gene-editing approaches now in development. Through rigorous science, global research infrastructure and close partnership with the worldwide patient community, PRF is advancing next-generation therapies, expanding diagnosis and care through its Find the Children initiative, and leading the Path to Cure Progeria program to determine whether a one-time gene-editing therapy can offer a durable, potentially curative treatment. For more information and to support PRF’s mission, please visit www.progeriaresearch.org.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Media Inquiries
The Progeria Research Foundation:
Tracy Lessor
Director of Communications
tlessor@progeriaresearch.org
Forge Biologics:
Marina Corleto
Associate Director, Marketing & Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian
Senior Vice President, Client Development
CD@forgebiologics.com
- Forge’s FUEL™ platform and cGMP manufacturing services support the production of AAV for Ascidian’s ACDN-01, the most advanced genetic therapy targeting the underlying cause of Stargardt disease
- Collaboration secures clinical supply needed to advance ACDN-01 into late-stage studies
BOSTON, MA and COLUMBUS, OH – January 7, 2026 – Ascidian Therapeutics (“Ascidian”), a biotechnology company seeking to treat human diseases by rewriting RNA, and Forge Biologics (“Forge”), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced a strategic partnership to advance the development and manufacturing of ACDN-01, Ascidian’s lead retinal program for the treatment of Stargardt disease.
Through this collaboration, Forge is providing Ascidian with process and analytical development services, toxicology, and current Good Manufacturing Practice (cGMP) manufacturing. Ascidian is utilizing Forge’s proprietary FUEL™ technologies, including HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid, along with program-specific optimizations designed to drive manufacturing efficiencies. All development and manufacturing activities take place at the Hearth, Forge’s 200,000-square-foot gene therapy development and manufacturing facility in Columbus, Ohio.
“We are proud to partner with Ascidian Therapeutics on this program, which reflects our shared commitment to bringing together scientific and manufacturing innovation to support patients,” said John Maslowski, President and Chief Executive Officer of Forge. “Forge’s FUEL™ platform technologies and manufacturing capabilities were built to enable partners like Ascidian as they advance their work through clinical development and beyond.”
Ascidian is currently evaluating ACDN-01—the most advanced genetic therapy targeting the underlying cause of Stargardt disease—in the Phase 1/2 STELLAR dose-escalation trial. ACDN-01 uses a single AAV vector to perform in vivo RNA exon editing, restoring full-length ABCA4 protein that is deficient in Stargardt patients. This first-in-class approach has already demonstrated durable, efficient editing in both non-human primate and human retinal models.
“ACDN-01 represents a fundamentally new approach to treating diseases driven by large, complex genes like ABCA4 which have historically been difficult to address with traditional gene therapies,” said Michael Ehlers, M.D., Ph.D., President and Chief Executive Officer of Ascidian. “Partnering with Forge Biologics equips us with deep AAV expertise, scalable manufacturing capabilities, and significant capacity, enabling us to rapidly advance ACDN-01 into late-stage clinical development.”
About Ascidian Therapeutics
Ascidian Therapeutics is redefining the treatment of disease by rewriting RNA. By editing exons at the RNA level, Ascidian therapies enable precise post-transcriptional editing of genes, resulting in full-length, functional proteins at the right levels, in the right cells, at the right time. With discovery, preclinical, and clinical programs in retinal, neurological, neuromuscular, and genetically defined diseases, Ascidian’s approach has the potential to treat patients with one dose of an RNA exon editor, opening new therapeutic possibilities for patients and their families who are seeking breakthroughs. To learn more about Ascidian, visit www.ascidian.com. To learn more about the STELLAR clinical trial, visit www.StellarStargardtTrial.com.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Media Inquiries
Ascidian Therapeutics:
Heather Shea
heather.shea@catalyticagency.com
Forge Biologics:
Media
Marina Corleto
Associate Director, Marketing & Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian
Senior Vice President, Client Development
CD@forgebiologics.com
- Avista will leverage Forge’s FUEL™ platform to manufacture AAV for AVST-101, Avista’s lead gene therapy to treat patients with X-linked retinoschisis (XLRS)
PITTSBURGH, Pennsylvania and COLUMBUS, Ohio – August 13, 2025 – Avista Therapeutics (“Avista”), a pre-clinical-stage biotechnology company developing novel AAV capsids with high efficacy and unique tropisms into innovative gene therapies for rare ophthalmic conditions, and Forge Biologics, (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced a strategic partnership to advance the development and manufacturing of AVST-101, Avista’s lead gene therapy candidate targeting X-linked retinoschisis (XLRS), a serious inherited retinal disease.
Through this partnership, Forge will provide Avista with process development, current Good Manufacturing Practices (cGMP) manufacturing, toxicology, and analytical development services. Avista will also leverage Forge’s proprietary FUEL™ technologies, including its HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy development and manufacturing facility in Columbus, Ohio.
“Partnering with Avista to support the advancement of AVST-101, their innovative intravitreal gene therapy for XLRS, aligns with our mission to help our clients accelerate the path to gene therapies for patients with urgent needs,” said John Maslowski, President and Chief Executive Officer of Forge. “Our AAV manufacturing services are designed to support programs like Avista’s with the speed, consistency, and quality required for success.”
AVST‑101 is a next-generation gene therapy designed to treat XLRS through an innovative combination of advanced capsid engineering, efficient intravitreal delivery, low-dose efficacy, and broad retinal coverage. Its development is a significant advancement in ocular gene therapy, representing a potentially safer, more accessible option for patients with inherited retinal disease.
“Forge’s AAV-specific manufacturing expertise and platform technologies give us confidence in a smooth path forward in the development of AVST-101,” said Robert Lin, Ph.D., Chief Executive Officer of Avista. “This collaboration further strengthens our ability to advance our mission of delivering transformative gene therapies to patients with vision loss.”
About Avista Therapeutics
Avista Therapeutics’ mission is to develop innovative gene therapies for retinal diseases, including rare ophthalmic conditions that have a profound impact on patients’ quality of life. We leverage our computationally guided scAAVengr platform to generate and validate a toolkit of proprietary AAV vectors that target specific cell types using minimally invasive intravitreal delivery with reduced dosages. Our quantitative, in vivo-based approach and clinical ophthalmology expertise allow us to rapidly translate new gene therapies to the clinic. To learn more, visit https://www.avistatx.com.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Investor & Media Inquiries
Avista Therapeutics:
Argot Partners
avista@argotpartners.com
Forge Biologics:
Media
Marina Corleto
Associate Director, Marketing & Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian
Senior Vice President, Client Development
CD@forgebiologics.com
- Fractyl Health will leverage Forge’s FUEL™ platform to manufacture AAV for Rejuva, Fractyl’s pancreatic gene therapy platform for patients with obesity and type 2 diabetes
COLUMBUS, Ohio – May 14, 2025 – Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an AAV development and manufacturing agreement to help advance Fractyl Health’s Rejuva* pancreatic gene therapy platform for the treatment of patients with obesity and type 2 diabetes (T2D).
“We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,” said John Maslowski, President and CEO of Forge. “We are proud to support Fractyl in advancing a new class of metabolic disease therapies. Their mission to break the cycle of chronic disease management for patients is one we are honored and excited to help enable.”
“We are excited to collaborate with Forge in advancing our Rejuva pancreatic gene therapy platform. Forge’s expertise in large-scale, efficient AAV manufacturing is invaluable as we move forward in our mission to develop scalable treatments that aim to prevent and reverse obesity and metabolic disease,” said Harith Rajagopalan M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health.
Through this relationship, Forge will provide Fractyl process development, cGMP manufacturing and analytical development services. Fractyl will also leverage Forge’s FUEL™ platform, including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio.
*The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com
Client Development
Taleen Barsoumian
Senior Vice President, Client Development
CD@forgebiologics.com
- Oral and poster presentations will highlight data demonstrating the enhanced productivity, recovery, and consistent quality of Forge’s FUEL™ AAV manufacturing platform, addressing the industry’s need for more efficient manufacturing
COLUMBUS, Ohio – May 6, 2025 – Forge Biologics (“Forge”), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced that it will deliver eight presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, taking place May 13-17, 2025 in New Orleans, Louisiana. The presentations include two technical session presentations, an oral presentation, and five scientific posters focused on Forge’s FUEL™ platform and manufacturing innovations for gene therapies.
“We’re proud to share Forge’s latest manufacturing advancements, underscoring our commitment to innovation as we help clients deliver transformative gene therapies to patients,” said John Maslowski, CEO and President of Forge. “Our experts will highlight how the FUEL™ AAV manufacturing platform, with its advanced technologies and product-specific optimizations, drives significant productivity gains. We’re also excited to present additional talks and posters on key analytical advances as we look toward a future of faster and more comprehensive analytics for product release.”
SESSION PRESENTATIONS
Sponsored Symposium
Title: “Great Science Needs Innovative Manufacturing Technology”
Presenters:
David Dismuke, Ph.D., Chief Technology Officer
Frank Agbogbo, Ph.D., Vice President of Process Development
Adam Davis, Ph.D., Vice President of Analytical Development
Date and Time: Wednesday, May 14, 3:45-4:15 p.m. CT
Location: Room 271-273
Tools & Technology Forum
Title: “Next-Gen Sequencing: Unlocking the Potential of Future Analytical Methods – Now”
Presenter: Esko Kautto, Ph.D., Senior Scientist, Analytical Development
Date and Time: Thursday, May 15, 1:30-1:45 p.m. CT
Location: Exhibit Hall Theater
ORAL PRESENTATION
Session: 230 Pharmacology/Toxicology Studies and Analytics/Assay Development Session I
Title: “Development of Highly Sensitive Liquid Chromatography Assays to Ensure Excipient Clearance in AAV Products”
Presenter: Micah Witte, Senior Scientist, Analytical Development
Date and Time: Wednesday, May 14, 3:45 p.m. CT
Location: Room 265-268
POSTER PRESENTATIONS
Title: “Enabling Innovation Through Transition to the FUEL™ Platform: Regulatory Feedback on the Comparability of Ad Helper Plasmid pEMBR™ 1.2 vs. pEMBR™ 2.0”
Presenter: Christopher Shilling, Chief Regulatory Officer
Date and Time: Tuesday, May 13, 6:00-7:30 p.m. CT
Poster # 976
Title: “Advancing rAAV Manufacturing with Long-Read Sequencing”
Presenter: Esko Kautto, Ph.D., Senior Scientist, Analytical Development
Date and Time: Tuesday, May 13, 6:00-7:30 p.m. CT
Poster # 835
Title: “Development of a High Throughput Flow Cytometry in vitro Relative Potency Assay as an Analytical Tool to Support rAAV Process Characterization”
Presenter: Julia Zalewski, Senior Associate Scientist, Analytical Department
Date and Time: Wednesday, May 14, 5:30-7:00 p.m. CT
Poster # 1487
Title: “Fueling Technological and Process Advancements for Increased rAAV Productivity to Meet the Industry’s Growing Demand”
Presenter: Corben Davis, Associate Director, Process Development
Date and Time: Thursday, May 15, 5:30-7:00 p.m. CT
Poster # 1938
Title: “Recent Advancements in Enhanced Starting Materials and Process Optimization for Manufacturing High Yield rAAV in Suspension HEK293 Cells in Single-Use Bioreactors”
Presenter: Jessie Chua, Ph.D., Senior Scientist, Process Development
Date and Time: Tuesday, May 15, 5:30-7:00 p.m. CT
Poster # 1951
Full abstracts are available on the ASGCT Annual Meeting website, and conference participants can also access posters through the ASGCT website.
Forge Biologics will be at booth #1337 in the Exhibitor Hall.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com
- FUEL™ platform can achieve a 2-6x increase in productivity compared to industry standard
- New innovative platform technologies include pEMBR 2.0™ Ad helper and modified rep/cap plasmids
- Data on FUEL™ platform will be presented at Cell & Gene Meeting on the Mesa
COLUMBUS, OHIO October 2, 2024 – Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced the launch of its FUEL™ manufacturing platform to provide AAV gene therapy developers a more efficient and accelerated foundation for manufacturing as they advance new programs and target a broader range of diseases.
The FUEL™ (Foundation for Unleashing Excellence in Life-Changing Therapies) platform introduces several new technical advancements, including Forge’s pEMBR 2.0™ Ad helper plasmid which is one of the smallest commercially available at 8.9kb, offering an enhanced safety profile and increased manufacturing efficiency. The platform also features new modified rep/cap plasmids, whereby a client-specific capsid sequence is incorporated into Forge’s proprietary backbone plasmid. Forge’s trusted HEK293 suspension Ignition™ cell line remains a vital component of the platform. Together, these proprietary technologies, combined with Forge’s proven manufacturing processes and unique optimization packages provide a faster, potentially safer, and more efficient foundation for AAV production.
“As a CDMO, we prioritize continuous innovation to deliver effective solutions for our groundbreaking clients who are focused on advancing their programs from the discovery phase to first-in-human clinical trials and beyond,” said John Maslowski, President & CEO of Forge. “The FUEL™ platform represents years of extensive R&D on our innovative technologies and builds upon our well-established manufacturing processes with a deep understanding of the need for product-specific flexibility with numerous optimization packages.”
“I’m incredibly proud of our team’s exceptional collaboration that has brought us to this point with the FUEL™ platform and the productivity gains we’re seeing,” said David Dismuke, Ph.D., Chief Technical Officer of Forge. “From molecular development’s research for our new pEMBR 2.0™ Ad helper design, to our process development team’s repeatable high-titer manufacturing processes, Forge remains focused on driving manufacturing excellence for our clients and the industry as it continues to expand and reach broader patient populations.”
Forge will launch the FUEL™ platform and highlight its key benefits during a company presentation by Mr. Maslowski on October 8, 2024, at 3:15 p.m. during the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa conference in Phoenix, Arizona. For more information, please visit https://meetingonthemesa.com/.
About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.
Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com