Preformulation & Preclinical Services

Our unique combination of high-quality science and engineering expertise is core to our offering at each stage of a product’s development and manufacturing cycle. We have formulated and advanced over 4,000 compounds across a myriad of problem statements, and Capsugel’s product-development sites have more than 70 years of collective experience producing clinical-trial materials. 

Over the years, we have developed proprietary technology-selection methodologies, predictive models, expert systems, formulation reference tools, specialized lab-scale equipment and micro-testing methods, which help ensure rapid feasibility assessments as well as optimized product design and development.

Preformulation

Capsugel provides integrated product-development services to its biopharmaceutical clients using a broad range of technologies to tackle formulation challenges. By colocating product-design, development and manufacturing operations at the same sites in the United States and Europe, we ensure rapid development through clinical studies and commercialization, as well as efficient technical transfer of innovative products. 

Capsugel’s integrated product-development sites provide rapid pre-formulation screening to assess and characterize drugs and excipients. We focus on fully evaluating the physical and chemical properties of each compound and its dosage-form requirements to develop tailored problem statements and guide preliminary formulation decisions. Physical and chemical characterizations provide our product-development teams with critical information about the properties of the compound and the best enabling technologies and formulation approaches.  

Capsugel enables rapid compound feasibility assessments with microdosing services for powder-in-capsule (PIC) studies. Capsugel Xcelodose® Precision Powder Micro-Dosing Systems are used for precise PIC microdosing of capsules for preclinical and Phase I and II studies. Our product-development teams have extensive experience with PIC studies, having produced more than 200 compounds and more than 600 batches.  This type of study has been shown to significantly reduce product development time by avoiding excipient-compatibility studies in early assessments.  

Capsugel has also developed specialized clinical capsules to further assist customers with their preclinical and clinical studies. PCcaps® capsules offer a simple approach to preclinical oral administration of pharmaceutical actives and formulations to rodents. DBcaps® capsules can readily be used to blind test compounds. All Color Capsules provide flexibility in capsule color decisions later in product development without incurring costly delays. 

Intrinsically enteric capsule technologies (Vcaps® Enteric and enTRinsic™ Drug-Delivery Technology) allow rapid proof-of-concept screening of compounds that require enteric protection or delayed release. By avoiding the use of functional coatings, significant time-savings can be realized in preclinical and clinical studies.

Preclinical Services

Capsugel provides full analytical development and validation in support of formulations for clinical-trial materials and commercial products. We have analytical staff located at each of our integrated product-development sites.

From our analytical development laboratories, which are fully Good Laboratory Practice (GLP)-compliant, our experienced teams of analysts provide:

EARLY DEVELOPMENT SERVICES

LATE DEVELOPMENT SERVICES

Compound handling protocols

Manufacturing process development

Drug characterization

Quality Control (QC) method development

Excipient compatibility testing and selection

Analytical method optimization, qualification and validation

Preformulation and formulation development

Cleaning methods / verification

Analytical method development and qualification 

Product release and stability testing

Release and stability testing

Clinical trial material manufacture

Clinical trial material manufacturing

QC/QP Release

Investigational New Drug (IND) / Investigational Medical Product Dossier (IMPD) support

Regulatory dossier support