Alcami Corporation | March 02, 2022
Alcami, a U.S.-based pharmaceutical contract development and manufacturing organization announced the addition of a 3,800 ft² Non-GMP Formulation Development Laboratory (FDL). The dedicated Non-GMP formulation development space, which is co-located within the same facility as Alcami's parenteral manufacturing operation that offers four isolator filling lines for liquid and lyophilized products, is ready to support customers with Preclinical and Clinical development programs.
"This is a truly a unique offering that will provide our clients' current and future development programs with flexibility, speed, and a streamlined progression throughout the drug development lifecycle,"
Louise Hall, Vice President of Formulation Development & Technology Transfer at Alcami Corporation
Alcami's Non-GMP Formulation Development Laboratory is outfitted with a high potency suite, lyophilization cycle development center, stability chambers to facilitate lead candidate selection, and the equipment to support a wide variety of research and early-phase development activities, including bench-scale manufacturing of drug product to support Preclinical studies. Furthermore, it is fully integrated within Alcami's RTP campus, encompassing over 100,000 ft².
"We are pleased to provide our clients with a seamless transition from characterization to formulation and analytical development through GMP manufacturing and analytical release," added Louise Hall.
Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging 675,000 ft² across the United States, Alcami serves pharmaceutical and biotech companies of all sizes providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami's private equity ownership includes Madison Dearborn Partners and Ampersand Capital Partners.
Thermo Fisher Scientific | September 03, 2021
Thermo Fisher Scientific's clinical sequencing business and AstraZeneca today announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca's expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement.
"As the pipeline of targeted therapies expands, the availability of diagnostic tools that can interrogate multiple biomarkers simultaneously will ensure patients can be matched with the right therapies more rapidly – this is the promise of precision medicine," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Introduction of diagnostic tools early in the process of drug development can further facilitate the success of companion diagnostic development – and that's what we're doing with AstraZeneca."
NGS-based companion diagnostics are increasingly used to match patients with new therapies for cancer and other diseases. More than 90 percent of AstraZeneca's clinical pipeline, across all main areas from oncology, cardiovascular and renal to metabolic and respiratory disease, are targeted precision medicine therapies.
"Using the latest diagnostic science allows us to match the best treatment to the patient," said Ruth March, senior vice president, precision medicine and biosamples, AstraZeneca. "This collaboration with Thermo Fisher offers the technology, expertise and ability to decentralize CDx tests to local healthcare providers across our global markets, which will help us identify more patients around the world who may benefit from treatments and effective patient care."
Thermo Fisher currently offers the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea and the Middle East, and covering more than 550 million lives globally.
To expand global access to a growing list of precision medicine therapies, in 2019 Thermo Fisher introduced the Ion Torrent Genexus System*, the first fully-integrated NGS platform featuring an automated specimen-to-report workflow that economically delivers results in a single day. The company's complete NGS workflow, powered by Ion AmpliSeq technology, includes multiple solutions for solid tumor biomarkers and liquid biopsy testing.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
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