The Mid-Atlantic Technology, | March 03, 2022
The Mid-Atlantic Technology, Research & Innovation Center announced it will establish the Center of Excellence for process design, defining a new standardized process development framework to streamline chemical manufacturing processes from laboratory bench through to commercial production. The initial projects will develop continuous processes for critical materials for the pharmaceutical industry currently substantially produced overseas. These new capabilities will be established as a result of the Department of Commerce’s recent Rapid Assistance (for) Coronavirus Economic Response grant to the RAPID Manufacturing Institute, of which MATRIC is a sub-awardee.
MATRIC—applying its unique infrastructure and subject matter expertise—will lead the specialty chemical manufacturing industry with this Center of Excellence focused on accelerated process design through modular processing. Onshoring the capability to move critical pharmaceutical material manufacturing processes from concept to commercial products will enable faster response times and fewer supply chain disruptions for the Nation.
“Today, the U.S. doesn’t have the manufacturing capability to produce some key raw materials and intermediates at scale to support our pharmaceutical industry and needs. The COVID pandemic and the current global supply chain issues have taught us the importance of supply chain stability and security, and this starts with critical raw materials produced domestically, distributed with purpose, and efficiently accessed.”
MATRIC Chairman & CEO Steven B. Hedrick
“At the beginning of the COVID pandemic, we struggled to get our families and front-line healthcare workers access to necessary PPE, disinfectants and other critical equipment. I applaud MATRIC for making this exciting investment and establishing the Center for Excellence right here in West Virginia. Their broad-based chemical technology expertise will also help improve domestic Active Pharmaceutical Ingredient (API) manufacturing, at a time when onshoring our pharmaceutical supply chain is critical,” said U.S. Senator Joe Manchin (D-WV). “West Virginia’s strategic location and MATRIC’s unique skillset will play a critical role in ensuring healthcare professionals across the country can quickly and efficiently get the equipment they need to safely do their jobs.”
MATRIC is a sub-awardee of the RACER grant from the Department of Commerce to the RAPID® Manufacturing Institute (RAPID). MATRIC will collaborate with RAPID, the project leader, and with partners at Teich Process Development and Procegence.
“Through its partnership with RAPID, Teich and Procegence, MATRIC’s Center of Excellence avails our economy with choices. Choices like this afford the opportunity to source from Americans for Americans, or to selectively buy from overseas, at their discretion,” said RAPID Executive Director & Chief Technology Officer Ignasi Palou-Rivera. “Just on the horizon, the most important raw materials and intermediates for pharma will again be made available inside the United States and not be locked down by a relatively inelastic supply chain originating in nations with substantial government control.”
RACER grants are awarded by the U.S. Department of Commerce to high-impact projects designed to fund awards for research, development, and testbeds to prevent, prepare for, and respond to coronavirus.
MATRIC is the strategic innovation partner of choice that provides uncommon expertise and infrastructure to solve the most challenging science and technology problems. Focusing on the areas of chemical, energy and environmental technologies, technical engineering and advanced software technologies, MATRIC delivers innovation from concept to commercialization. We utilize our experienced and renowned staff, unique laboratory and pilot plant facilities, and flexible intellectual property models to create value for customers and investors around the world. We are an energized and expanding company that works from facilities in South Charleston and Morgantown, W.Va.
About RAPID® Manufacturing Institute
RAPID serves as a nexus between process innovation, economic development, and job creation. The technology development and educational programming we sponsor will increase energy and operational efficiencies, enhance productivity, and improve sustainability, making U.S. manufacturing in the chemical process industries (CPI) more competitive in the global market and developing the next generation workforce for these industries.
Merck | October 29, 2021
Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future.
"ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities.
Andrew Bulpin, head of Process Solutions, Life Science, at Merck
With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated.
The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year.
In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs.
This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver.
With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio.
Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health.
Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.
Edenbridge Pharmaceuticals | March 01, 2022
Edenbridge Pharmaceuticals, LLC announced that DARTISLA ODT is now available by prescription in the United States through Phil, the commercialization partner and eHub for DARTISLA ODT, as well as in retail pharmacies throughout the country. To ensure access to patients in need, Edenbridge is sponsoring the DARTISLA ODT Copay Program, which allows eligible patients to obtain the product for as little as $0 when filled through Phil or $20 when filled at other pharmacies.
“DARTISLA ODT is the first and only FDA-approved orally disintegrating tablet of glycopyrrolate, and we are excited to introduce this novel formulation of glycopyrrolate to patients and healthcare providers,” noted Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and General Counsel. “Further, Edenbridge is committed to ensuring patient access to this product, and we are pleased to be sponsoring the DARTISLA ODT Copay Program to facilitate getting DARTISLA ODT into the hands of people that need it most.”
“Phil is proud to support Edenbridge’s commitment to providing broad access to this innovative therapy by simplifying the patient onboarding process allowing affordable, fast, broad-based distribution of Dartisla ODT,”
Deepak Thomas, Founder and CEO of Phil
The U.S. Food and Drug Administration (FDA) approved Dartisla ODT for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer on December 16, 2021. DARTISLA ODT is manufactured by Catalent using their proprietary Zydis® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water.
Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT. DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention.
Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings.
Phil is a commercialization partner for innovative life sciences companies, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers can provide patients with more affordable and timely therapy access.