Grace’s FCMS has 40 years of custom manufacturing experience with US biotechnology companies
By Scott Martin, Grace's FCMS
Biotechnology companies have a long and broad list of needs when considering working with a contract development manufacturing organization (CDMO). Does a CDMO have experience with the chemistry needed to manufacture a particular product? Does it offer the operations—such as kilo labs, a pilot plant, and reactors in multiple sizes—necessary for a successful scale-up? What is a CDMO’s history of quality and regulatory compliance?
W.R. Grace’s Fine Chemical Manufacturing Services (Grace’s FCMS) has specialized in addressing these needs for decades. It supports customers with integrated R&D, manufacturing, analysis, and regulatory compliance throughout the drug discovery and development pipeline. Two US-based facilities manufacture regulatory starting materials. At Grace’s FCMS current good manufacturing practices (CGMP) site, scientists and engineers develop custom active pharmaceutical ingredients (APIs) under cGMP.
“Scientists and engineers at Grace’s FCMS have seen a lot of chemistry throughout the company’s 40 years of operations, and they’ve helped solve a lot of problems,” says Scott Martin, general manager of the firm’s global business unit.
Grace’s FCMS services include developing a commercially viable synthesis route, manufacturing small molecules on all scales from demonstration campaigns to commercialization, and supporting quality assurance through every step of the development process. Some of their chemists have been on site for over 30 years, and customers are assured that seasoned experts are working on their projects.
"Grace’s FCMS does all of the process development, scale-up, and analytical method development work in-house," Martin says. Because Grace’s FCMS does not outsource any design or method development work, customers’ custom APIs and reaction intermediates move smoothly and quickly through the scale-up process.
Recently, Grace’s FCMS worked with several biotech companies going through the US Food and Drug Administration fast-track approval process for critical diseases.
"To fast-track a pharmaceutical regulatory approval process takes coordination, fast response, and capability," Martin says. “The typical time from when Grace’s FCMS first gets involved to when a drug enters the market is 7 years. With fast tracking, that time frame can shrink to 2 or 3 years.”
With Grace’s FCMS, fast tracking involves compressing many processes while assuring successful validation of the new API. The in-house analytical chemistry department develops and validates methods needed for FDA filings.
While continuous manufacturing is not appropriate for all biotech products, Grace’s FCMS can implement flow chemistry when it makes sense. "With one customer, we were able to expand the capacity fourfold by converting from batch to continuous processing," Martin says.
Small-scale processes commonly used to make products in the pharmaceutical industry typically lend themselves to batch processing, and designing a batch chemistry process can be faster than continuous manufacturing design. Experts at Grace’s FCMS work with customers to plan projects to meet a customer's primary objectives.
Excellent safety record
Grace’s FCMS manufacturing plants are backed by excellent safety records. The South Haven, Michigan API site is an Occupational Health and Safety Administration Voluntary Protection Program Star site, which means health and safety management systems at this site exceed national industry averages.
As a small molecule solution provider, Grace’s FCMS has pivotal role in making bulk API that enables biotech companies to scale a product every step along the pipeline. Says Martin: "We have the flexibility, capacity, and capabilities to help customers bring new products to market quickly."
Contact us to learn more about how to work with Grace’s FCMS.