Choosing a small-molecule drug substance partner

Five factors to consider when contracting with a small-molecule drug manufacturer

When pharmaceutical companies want support with drug development and drug manufacturing, they turn to contract development and manufacturing organizations (CDMOs). Outsourcing demonstration batches, method development, stability studies, scale-up, and commercial production means a pharmaceutical company can focus on other aspects of the business, such as drug discovery or marketing rather than on manufacturing.

With many CDMOs to choose from, picking the best manufacturer for a particular drug substance can be challenging. Here are five factors to consider when deciding on an optimal CDMO for small-molecule chemistry.

Materials: Developing novel pharmaceuticals requires regulatory starting materials (RSMs) and active pharmaceutical ingredients (APIs). Look for a CDMO with ready access to both components produced with current good manufacturing practices.
Expertise: Manufacturing small-molecule drug substances involves expertise in research and development, analysis, manufacturing, engineering, and regulatory compliance. CDMOs that operate as integrated teams across these areas of expertise carry products smoothly from concept to commercialization.
Scale-up capability: Drugs in clinical trials or pharmaceuticals in targeted indications, such as some oncology drugs, need smaller production volumes than common drugs that treat diseases such as diabetes and heart disease. CDMOs that can operate at a variety of scales are poised to support technology transfer from the lab to pilot production to commercial use.
Regulatory compliance: Meeting—and even exceeding—safety and regulatory requirements is a basic requirement. Look for a CDMO with a strong track record of regulatory compliance to ensure delivery of a high-quality product.
Timing: A company’s capabilities and location can help ensure that manufacturing aligns with customer timelines. CDMOs with facilities to produce have flexibility that will be most efficient to meet customer timelines. In-house capabilities for analytical and compliance services mean there is no need to outsource any aspect of a project.

Grace’s Fine Chemical Manufacturing Services (FCMS) has over 4 decades of experience helping biotech companies get their products to market. The firm supports customers with integrated R&D, manufacturing, analytical services, and regulatory compliance throughout the drug discovery and development pipeline.

Grace’s FCMS has one API plant and one RSM plant, both located in the US. These integrated sites provide a domestic supply of high-quality materials that meet current good manufacturing practices and regulatory requirements; they operate commercially at production scales ranging from a few kilograms to hundreds of metric tons.

While working on a customer’s API or RSM, scientists and engineers at Grace’s FCMS perform all process development and analytical method development in-house. Because Grace’s FCMS does not outsource any design or method development work, products move smoothly and quickly through the scale-up process.

"Biotech companies usually come to Grace’s FCMS needing to scale their molecule from early development through commercialization,” says Brian Graves, Business Development Manager of Grace’s FCMS global business unit. "Getting APIs to market quickly is the strength and focus of our business."