PHARMACY MARKET
Evergreen Theragnostics, Inc. | July 17, 2021
Evergreen Theragnostics, Inc., a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) has started a major strategic expansion at its Springfield, NJ manufacturing facility.
Evergreen has already started expanding to build a GMP state-of-the-art alpha emitter production center, incorporated into Evergreen's current facility, with the Evergreen Springfield Facility scheduled to open within the next two months. The expansion, which is scheduled to open in the first quarter of 2022, will strengthen Evergreen's capacity to serve alpha-based radiopharmaceutical projects from pre-clinical pharmaceutical research through commercial production and supply. Evergreen's new alpha program will research and manufacture novel radiopharmaceuticals, including Actinium-225 (Ac-225), Astatine-211 (At-211), Lead-212 (Pb-212), and Thorium-227 (Th-227).
Targeted Alpha Therapy (TAT), which uses the radionuclides mentioned above, is a growing segment of therapeutic radiopharmaceuticals owing to its unprecedented promise of improving patient clinical outcomes in cancer. This new class of medicines, however, poses significant difficulties in both clinical development and manufacturing.
The new facility was created by combining Evergreen's expertise in clinical production of TAT radiopharmaceuticals with a collaboration with Tema Sinergie, a leading supplier of radiopharmaceutical manufacturing equipment. This resulted in developing specifically made production equipment to meet the challenges associated with manufacturing alpha-emitting radiopharmaceuticals in a complete cGMP environment.
About Evergreen Theragnostics, Inc.
Evergreen Theragnostics, founded in 2019, is a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in the United States. Evergreen will offer highly reliable manufacturing services for therapeutic and centrally distributed diagnostic radiopharmaceuticals from early development through commercialization, with a state-of-the-art global GMP facility opening in Q3'21. The company was founded by a team with extensive experience in radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management.
About Tema Sinergie
Tema Sinergie, founded in 1985, is a pioneer and global leader in the design and manufacture of shielded isolators for the nuclear medicine market, consistently working to extend its proven leadership onto the market of aseptic containment isolator systems to the pharmaceutical, biotech, and ATMP business branches. The company has obtained ISO 9001 and ISO 13485 certifications.
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PRACTICE MANAGEMENT
Aprecia Pharmaceuticals | October 21, 2021
Kyle Smith has been named President and Chief Operating Officer of Aprecia Pharmaceuticals, LLC, effective immediately. Mr. Smith is a 10-year veteran with Aprecia and has served as Vice President of Operations for the past 3 years. As President and Chief Operating Officer, Mr. Smith will be responsible for leading day-to-day business activities.
Aprecia has further strengthened its leadership team by promoting Patrick Staudt to Vice President of Operations, effective immediately. A 14-year veteran of Aprecia, Mr. Staudt has led the East Windsor, NJ manufacturing operations for more than 10 years and has demonstrated the talent and experience to lead expected, expansive growth through multiple technology platforms.
Mr. Smith and Mr. Staudt have been cornerstones of Aprecia's history of technology and manufacturing innovation. They have been key contributors in establishing the company as the leader in the development and manufacturing of pharmaceutical products through 3D-Printing. Their experiences with Aprecia have helped craft the company culture and 3DP pharmaceutical manufacturing innovation, and their contributions have created a momentum which continues to accelerate through important partnerships and novel products.
"As Aprecia's technology platforms expand and industry partnerships advance, Aprecia requires additional talent and resources to meet these growing demands, We are fortunate to have these seasoned technology experts and corporate leaders to promote and guide the organizational growth well into the future."
Chris Gilmore, Aprecia's Chief Executive Officer
Mr. Kyle Smith holds a Master of Business Administration degree from Miami University, and a Bachelor of Science in Chemical Engineering from Georgia Institute of Technology.
Mr. Patrick Staudt holds a Bachelor of Science degree in Biomedical/Medical Engineering from Drexel University.
About Aprecia
Founded in 2004, Aprecia received the first and only FDA approved three-dimensionally-printed (3DP) pharmaceutical product approval in 2015. Aprecia uses its ZipDose® Technology to create rapidly disintegrating oral dosage forms that are easy to take and easy to administer. Without compression during the 3DP manufacturing process, engineered and coated particles such as taste masking and modified release are possible on large dose products (over a 1000mg). Aprecia directly owns a patent estate for novel 3DP machines and pharmaceutical 3DP applications. It licenses its exclusive technology platform to pharmaceutical partners as a means to extend product lines, improve patient reach and experience, and address FDA requirements as a pediatric delivery form.
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PHARMACY MARKET
HCmed Innovations Co., Ltd | March 07, 2022
HCmed Innovations, Co., Ltd. (HCmed) has announced a strategic agreement with Formosa Laboratories, Inc. and Formosa Pharmaceuticals, Inc. to expand its inhalation therapy business by offering contract development and manufacturing services. The three parties expect to become a one-stop shop in the biopharmaceutical industry as a full-service contract development and manufacturing organization by combining HCmed's vibrating mesh nebulizers, Formosa Laboratories' drug development and manufacturing capabilities, and Formosa Pharmaceuticals' APNT nanotechnology platform (CDMO).
According to data, the global market for inhalation drugs will reach $25 billion in 2020. Furthermore, as the COVID-19 pandemic has increased demand for respiratory treatment drugs over the last two years, so needs for developing respiratory drugs, prompting several well-known global pharmaceutical companies to take the lead in incorporating HCmed's proprietary mesh technology into the development of their inhaled products.
"Currently, global CDMO companies that focus on developing drug-device combination products cannot only provide their Pharma partners with a platform to deliver drugs, but also with integrated services that extend to drug development, mass production, and product packaging. Through these services, the combination product development time can be shortened, and costs can be reduced. With this objective, HCmed, Formosa Laboratories, and Formosa Pharmaceuticals aim to provide a fully integrated CDMO service platform, which is expected to expand the companies' business further, providing fully-integrated solutions and creating long-term win-win relationships."
CEO of HCmed, Jason Cheng
The two companies have similar ideas on how to grow their CDMO businesses. In the respiratory medicine industry, the agreement represents the merging of three significant leaders in the biotechnology and high-end medical device industries. With Formosa Pharmaceuticals' nanotechnology platform, Formosa Laboratories' API, ADC, and injection development and production experience, and HCmed's technology in developing customized mesh nebulizers, the parties hope to provide a comprehensive service across the entire development process, including early drug development, clinical trial execution, mass production, and product launch. This partnership is
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