R&D

With 40+ years of experience and new investment in expanded R&D facilities, Grace's Fine Chemical Manufacturing Services (FCMS) team is a leading CDMO who will collaborate on the development of your cGMP pharmaceutical or nutraceutical project. From the lab to the pilot plant, and all the way through commercial production, we have the technical skills and experience to achieve your goals with optimized speed, efficiency and meeting all compliance requirements.

Easy access to know-how

Not only has Grace's FCMS successfully developed hundreds of APIs over many decades, including a portfolio of proprietary generic APIs that we supply today, but we are one of the few in the industry to have consistently integrated development of RSMs domestically with scale-up all the way to commercial API manufacture in U.S. facilities. The R&D support, accessibility of this know-how, and capability are the fundamental differences between Grace’s FCMS and other outsourcing options.

Proven track record of scale-up success

Seasoned R&D technical group of organic chemists (Ph.D.s), supervising contract service operations across our labs

R&D expansion

In 2019, Grace's FCMS completed a 9,000 sq. ft capacity expansion of our R&D facilities, creating vastly more space for our teams to work on our customer’s projects at lab scale and kilo lab. Our experience and state-of-the-art facilities and equipment will progress your drug substance faster and more efficiently than ever before, providing solutions to development challenges.

Tightly integrated teams

Grace's FCMS R&D and analytical teams at South Haven, Michigan and Tyrone, Pennsylvania, are able to work together easily and bring diverse collective knowledge across regulatory starting materials (RSMs), intermediates and active pharmaceutical ingredients (APIs).

Development, testing, and validation

At our two facilities, we perform analytical development, stability studies and on-site validation. Our custom R&D group comprises chemists, engineers and analytical professionals dedicated to the advancement of your project.

Robust testing and validation

We can work with your technology or use our extensive resources in chemistry and chemical engineering to develop, test and validate efficient new processes. We subsequently thoroughly test these processes to optimize development time and costs. These are strengths that we are particularly proud of.

Group in South Haven dedicated to method development and validation for GMP products.

Process engineering team who work with chemists to translate lab processes into the pilot plant, ensuring seamless technology transfer.

Analytics services and equipment

Services	Equipment
Method Development Method Validation Problem Solving Stability Studies Cleaning Studies Impurity Identification Mass Spectrometry Chromatography Thermal Testing Elemental Impurity Analysis Physical Properties	GC and GC/MS FID, TCD GC Headspace HPLC Variable wavelength Diode Array, ELSD, Refractive Index, CAD detectors Viscosity Brookfield Ubbelohde / oil bath or autoviscometer High-resolution UPLC-MS (Q-TOF) Traditional wet chemistry methods, autotitrator	Coulometric KF XRD DSC Flashpoint, Melting point, Ash, FT-IR, UV, DLS, others TGA/DSC NMR Polarimeter for Chiral Analysis Particle Analysis using Malvern Analyzer IC (Ion Chromatography) ICP-MS with microwave digestion IMS (ion mobility spectrometers)

Featured

CDMO

Grace FCMS is a premier CDMO offering RSMs, intermediates, and high-value APIs across our network of U.S. facilities. We also offer a portfolio of generic APIs.

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