Theradaptive Receives MSCRF Manufacturing Assistance Grant to Help Establish New cGMP Facility in Frederick

July 6, 2023

Theradaptive, a pioneering biopharmaceutical firm focused on targeted regenerative therapeutics based in Frederick, Maryland, has been granted the Manufacturing Assistance Program by the Maryland Stem Cell Research Fund (MSCRF). This significant award will enable Theradaptive to establish their state-of-the-art GMP Manufacturing Facility in Frederick, Maryland, contributing to economic development and solidifying the state’s position as a thriving hub of biotechnological innovation.

This latest grant is coming on the back of a $26 million Series A funding round that the company closed in June of this year that will be used to drive the fulfillment of regulatory requirements and facilitate the scaling up of Good Manufacturing Practices (GMP) in anticipation of first-in-human clinical trials scheduled for later this year.

Its innovative protein-engineering based therapeutic delivery platform aims to precisely target and deliver biologics to address unmet medical needs in spine, orthopedics, soft tissue repair, and immuno-oncology. This platform aims to improve efficacy, safety, and ease of use across various clinical areas, including orthopedics, immuno-oncology, and dental care.

The MSCRF, a fund administered by the Maryland Technology Development Corporation (TEDCO), has played a crucial role in supporting stem cell research, fostering cures, and promoting commercialization in Maryland, having invested over $177 million to date. The Manufacturing Assistance Program grant awarded to Theradaptive will specifically aid in scaling up the production of their OsteoAdapt regenerative therapeutic product. This expansion is in preparation for the product’s first-in-human clinical trials, with a focus on spine and trauma repair applications.

Kevin Anderson, Secretary of Commerce at the Maryland Department of Commerce, expressed enthusiasm about the award, stating, “Maryland Commerce is thrilled to support Theradaptive, an ambitious and innovative company whose new facility will help drive economic development and enhance our state’s reputation as a leading biotechnology hub. As Theradaptive approaches human trials, this new funding will create jobs and help set Maryland apart as one of the most attractive biotech investment areas in the US.”

Ruchika Nijhara, Executive Director at the Maryland Stem Cell Research Fund, emphasized the grant’s significance, saying, “The recent award of a Manufacturing Assistance Program grant to Theradaptive represents MSCRF’s commitment to fostering the growth of Maryland cell-based therapy companies and facilitating the establishment of biomanufacturing capabilities within the state. We are excited to witness the development and expansion of their GMP OsteoAdapt Manufacturing Facility in Maryland, which will play a pivotal role in increasing the production of their orthopedic product. Through this growth, we anticipate a positive impact on patient outcomes, benefiting millions of individuals in need.”

Ed Fix, Vice President of Manufacturing at Theradaptive, expressed gratitude for the award, stating, “We are deeply honored to be awarded a Manufacturing Support Award by MSCRF. This award will enable us to establish our own cGMP manufacturing capabilities at our Frederick headquarters and allow us to tap into the rich pipeline of talent in the Maryland area. Manufacturing will be a critical piece in our journey to bring life-changing therapies to patients.”

Theradaptive, founded in 2016 was also the recipient of the 2018 and 2019 Maryland Stem Cell Research Fund Commercialization Grant. The company’s commitment to advancing medical technology and improving patient outcomes aligns with Maryland’s goal of fostering biotechnological innovation and growth in the state.

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