A Proven Approach to Impurity Control Across API and RSM Synthesis

W. R. Grace & Co.’s history of exceeding customer expectations is built upon our unyielding commitment to innovation and advancement of technical expertise, which is reflected throughout the drug development process.

Grace’s Portfolio for Pharmaceutical Solutions Includes:


Fine chemicals synthesis expertise
Decades of experience in organic chemical synthesis at our fully integrated North American sitesUnique multifunctional excipients 
SYLOID® multifunctional excipientsSILSOL® silica active ingredient delivery technologyHighly efficient chromatography resins 
DAVISIL® silica, VYDAC® chromatography resins, and VYKING™ superparamagnetic silica

Grace’s Fine Chemical Manufacturing Services (FCMS) has the facilities and expertise to support product development at every stage, from contract research through commercial manufacturing. Having the appropriate resources where you need them, when you need them is critical, and our multiple locations and deep experience can help ensure your success.

SYLOID® FP silica’s unique, innovative design combines adsorption capacity, particle size, density, and internal surface area to provide multifunctional benefits or optimize an application. This helps minimize the number of excipients used and the complexity of formulations while expediting manufacturing, ultimately improving the efficacy of the final dosage form.

An article demonstrating the importance of a kilo lab for small molecule scale-up and how Grace designed its Kilo Lab to mirror full scale production to make scale-up easier for sponsors.

The role of peptide building blocks in the innovation of peptide therapeutics.

The complexity of securing a supply chain for peptide therapeutic raw materials including complex peptide building blocks.

An article outlining how impurities may be identified & controlled by a Small Molecule CDMO.

Feed rate and manifold pressure are two critical operating parameters that have the greatest impact on the final particle size. The goal is to achieve a consistent feed rate, as well as reduce blockages inside the mill so as not to starve or overfeed the milling chamber.

The first experiment evaluated whether the addition of different concentrations of SYLOID® mesoporous silica could prevent build-up inside a jet mill, using cholesterol as the active ingredient. Cholesterol was selected because it is a waxy, difficult to process solid, with many of the same physical properties as many complex small molecules currently under development. The results demonstrated that run time and yield both significantly improved with small additions of SYLOID® mesoporous silica, which would indicate similar positive outcomes for a difficult-to-micronize API.

Co-processing or co-jet milling is an approach that can help resolve some of the static and flow issues, making downstream blending and formulation easier. This involves adding a low percentage of a functional excipient to the micronization process – selecting one already found in downstream formulations can help simplify the process. 

The second experiment evaluated the impact of various percentage additions of SYLOID® 244 FP mesoporous silica on powder flow properties and static reduction, using acetaminophen and ibuprofen as model compounds. Testing was also conducted to evaluate the impact of pre-blended, post-blended or co-fed approaches.

Grace's range of Magnetic Separation Technology for In-vitro Diagnostics