Business Wire

Forge Biologics Fuels Gene Therapy Manufacturing Engine with Launch of Plasmid DNA Manufacturing Services to Support AAV Clients

Share

Forge Biologics, a gene therapy-focused contract development and manufacturing organization, today announced the new availability of plasmid DNA manufacturing to its suite of scalable manufacturing services for gene therapy programs, complementing Forge’s existing AAV process development, analytical development, cGMP manufacturing, and automated final fill capabilities.

Forge’s plasmid manufacturing services encompass three grades to accommodate a phase-appropriate approach: Research-Grade, suitable for discovery, research and development; GMP-Pathway, suitable for early-stage clinical trial cGMP AAV manufacturing, and cGMP, suitable for late-stage clinical and commercial cGMP manufacturing. Forge’s plasmid production services utilize single-use systems that seamlessly integrate into the Company’s platform AAV manufacturing process, allowing continuity of manufacturing for clients and streamlined vendor management. Research-Grade and GMP-Pathway plasmid grades are currently available, with cGMP plasmid production available in 2023. All plasmid production will occur at Forge’s manufacturing facility, the Hearth, in Columbus, OH, and is available exclusively to clients performing their AAV manufacturing at Forge.

“The launch of plasmid DNA manufacturing enables clients to better streamline the production of their AAV programs by vertically integrating plasmids into our manufacturing process,” said John Maslowski, Chief Commercial Officer of Forge. “The ability to streamline vendor management, better control timeline risks, and accelerate end-to-end AAV manufacturing are important differentiators when upscaling to our 5,000L cGMP bioreactors for clients and patients. We are excited to present the data supporting our now-available services at BioProcess International East this week.”

The Company will deliver data presentations highlighting plasmid production in up to 50L fermenters and AAV manufacturing up to 1,000L at the BioProcess International Conference & Exhibition, taking place in Boston, MA, September 27-30, 2022.

Poster Presentations

Title: Process Development and Scale-Up of Plasmid DNA Production in 1-50L Single Use Fermenters for Accelerating AAV Manufacturing
Presenter: Frank Agbogbo, Ph.D., Vice President, Process Development

Title: Development of a Platform Process for AAV Production
Presenter: Frank Agbogbo, Ph.D., Vice President, Process Development

Title: Development of a Scalable Purification Process for High Grade Plasmid DNA
Presenter: Donald Belcher, Ph.D., Senior Scientist, Process Development

Title: Purification of AAV from 1L to 1,000L Batch Sizes
Presenter: Ganesh Krishnamoorthy, Ph.D., Associate Director, Process Development

Title: Production and the Scale-Up of rAAV from 1L to 1,000L in Bioreactors
Presenter: Steven Wesel, Associate Director, Process Development

Posters will be displayed—and participants can also access them—on the BPI conference website.

About Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility focused on AAV manufacturing and can host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Inquiries
Marina Corleto
Senior Manager, Marketing and Communications
media@forgebiologics.com

Client Development
John Maslowski
Chief Commercial Officer
CD@forgebiologics.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

BLUETTI Opens First Flagship Store in Munich, Germany for Hands-on Experience3.12.2022 12:40:00 EET | Press release

To enhance the user experience, BLUETTI, a top-three solar generator brand, has opened its first physical storefront in Munich, Germany, on November 4. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221202005505/en/ (Photo: Business Wire) This so-called WOC X BLUETTI store is set up as a physical hub of what the brand represents online. It showcases BLUETTI's entire product range, from the latest releases to iconic models, along with other accessories. Customers can get a real feel for products before making any purchases. However, it does not currently offer repair services. BLUETTI's new inventions, the AC500&B300S and EP600&B500, are already displayed there. Both are modular in design and substantially updated in capacity and capability. With a 5.000W output and 16 outlets, the AC500 can be used as a solid backup power source on the go or in the house. Sporting a max capacity of 80kWh, the EP600 can be integrated into exi

Esri Named a Leader in 2022 Climate Risk Analytics Report by Independent Research Firm2.12.2022 18:42:00 EET | Press release

Organizations are using modern geographic information system (GIS) technology to better understand the risks presented by climate change and take action. With GIS-driven mapping, analytics, and visualization, leaders can weigh the costs and benefits of plans, mitigate climate-related damage to assets, and make sustainable decisions despite an unpredictable planet. Esri—the global leader in GIS used by many Fortune 500 companies and governments worldwide to improve these sustainability practices—has been recognized by independent research firm Forrester in its report, The Forrester New Wave™: Climate Risk Analytics, Q4 2022. In the report, authored by principal analyst Renee Murphy, Esri received a differentiated rating, the highest score possible, in nine out of ten criteria, including “Advanced Data Processing,” “Visualization,” and “Threat Modeling.” The Forrester report says Esri “offers leading data visualization and advanced processing capabilities,” and that “Esri’s platform acts

Huawei Publishes First White Paper on Approaches to Fairness, Equity & Opportunity2.12.2022 06:07:00 EET | Press release

Huawei called on the ICT industry players to create a level playing field for all people, not just their own employees in its first White Paper on Approaches to Fairness, Equity & Opportunity at their Women in Tech event held at the Peter Drucker Forum. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221201006045/en/ (Graphic: Business Wire) This White Paper is part of Huawei's ongoing campaign aimed at increasing digital skills education and access for women across the world. Huawei, like many other companies within the ICT industry, has advocated on fairness, opportunity, and equity within their own operations. Notably, the company has taken measurable steps to increase diversity in their workforce and increase internal representation of marginalized groups. It is widely understood that significant, tangible results from such programs are often slow to materialize. And thus Huawei has focused many of its efforts beyond the

H&M and Webhelp Finalize Acquisition of H&M’s Nuremberg Customer Service Center1.12.2022 18:29:00 EET | Press release

The responsible authorities have officially approved the transfer of fashion brand H&M’s Nuremberg customer service center to Webhelp, a leading global customer experience BPO player. The companies, having already signed an agreement in this regard on 19 October 2022, will see Webhelp operate the service center from 1 December onwards under its own name. With this acquisition, Webhelp doubles the number of its employees in Nuremburg and is now one of the largest employers in the industry in northern Bavaria. Today, Webhelp employs more than 110,000 employees in over 60 countries. Webhelp's German headquarters in Nuremberg already provides an attractive working environment with state-of-the-art technical equipment for over 500 employees. Furthermore, Webhelp is committed to investing in the development and wellbeing of its customer advisors, known as 'game-changers,' around the world. Webhelp will welcome the 500 employees of the H&M Service center from today, 1 December, to the Webhelp

Morgan Stanley Sustainable Signals: New Survey Shows Opportunities Exist for Asset Managers to Better Meet Asset Owner Sustainable Investing Needs1.12.2022 18:00:00 EET | Press release

Asset managers have the opportunity to meet asset owners’ growing demands for sustainable investment practices, products and reporting, according to new research by the Morgan Stanley Institute for Sustainable Investing. The latest in the Firm’s Sustainable Signals series, this institutional investor survey polled 110 asset owners in North America, Europe and Asia, as well as 201 asset managers across the same regions to understand what asset owners want and what asset managers are offering—and where the gaps lie in delivering environmental, social and governance (ESG) solutions. “The results of our latest Sustainable Signals survey show that sustainable investing remains an important focus area for institutional investors globally, with the vast majority reporting an increased interest over the past two years,” said Jessica Alsford, Chief Sustainability Officer and CEO of the Institute for Sustainable Investing at Morgan Stanley. “At the same time, our findings show a significant oppo

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom