Formulation and Process Development

DRUG PRODUCT FORMULATION AND PROCESS DEVELOPMENT THAT NEVER FALLS SHORT

Advancing from molecular understanding to a manufacturable drug product requires sound judgment, disciplined science and a partner who knows how to manage risk without slowing progress. Our formulation and process development services are built to deliver a calculated, secure path from early development through clinical readiness.

Grounded in deep scientific expertise spanning molecule types, dosage forms and routes of administration, our teams design development strategies that are fit for purpose, phase-appropriate, and resilient to change.

Formulation development and process development are closely connected, but intentionally distinct. Our size and structure means your program is supported by the latest technologies without getting lost in the shuffle and scales with confidence.

By approaching these activities in parallel, and with a clear view of long-term requirements, we help reduce technical risk, avoid unnecessary rework, and accelerate the transition from development into clinical supply manufacturing.

Designed for flexibility, built for delivery

Our teams specialize in preclinical and clinical development, where uncertainty is highest and flexibility matters most. We design formulations and processes that are aligned to your actual goals, allowing you to conserve material, control cost, and adapt as new insights emerge.

Our formulation and process development services include:

Formulation Development

Design and optimization of drug product formulations informed by materials characterization and intended route of administration, including oral topical, ophthalmic, and parenteral drug delivery.

Process Development

Development of robust, scalable and transferable processes that prepare formulations for clinical manufacturing while maintaining quality, control and reproducibility. Transition with ease through clinical phases with manufacturing processes designed and characterized by our teams for scale-up and robustness.

Bioavailability Enhancement Development Strategies

Application of various non-proprietary bioavailability enhancement approaches, evaluated to support optimal formulation selection.

Bioavailability enhancement

Material-Sparing Development Programs

Thoughtful study design that delivers meaningful data while minimizing material consumption, particularly critical in niche therapeutic programs with limited drug substance.

Integrated Analytical and Technical Support

Close collaboration with analytical development teams to ensure methods, specifications, and process understanding evolve together.

Seamless Transition to Clinical Manufacturing

Development work aligned with supporting efficient progression into clinical supply. Whether your program leverages established approaches or emerging technologies, we support a variety of manufacturing platforms.

Clinical supplies manufacturing

Supported dosage forms and routes of administration

Solid Dosage Forms

Extensive preformulation screening of solid form rendering techniques provides you with a choice of potential crystalline forms, salt forms, cocrystals, and non-crystalline materials. Our team selects appropriate techniques to manufacture pharmaceutical materials at scale through processes like crystallization and spray drying. Simultaneously, we assess the characteristics and potential challenges associated with the solid form throughout manufacturing, storage, and administration.

Liquid and Semi-Solid Dosage Forms

Solutions, suspensions, and semi-solids are a diverse category which encompasses a versatile range of formulations. Whether it’s injectable or encapsulated, oral or ophthalmic, we collaborate to refine your drug product composition then evaluate prototypes under stressor studies, such as accelerated aging, photostability, and container compatibility.

Parenteral Dosage Forms

Parenteral delivery requires highly specialized formulation and manufacturing capabilities to ensure sterility, stability, and patient safety. Our team supports the development of drug products for intravenous, intramuscular, and subcutaneous administration. We evaluate critical parameters such as solubility, excipient compatibility, container closure systems, and reconstitution profiles.

Oral Administration

Maintaining the active ingredient amidst oral delivery pathways requires a formulation capable of withstanding the low pH environment of the stomach until the target release area. Our expertise spans tablets, capsules, and multi-particulates and powders.

Oral and topical drug manufacturing

Injectable Administration

We integrate molecular properties with formulation, delivery, and device systems to develop patient-friendly products with optimal market potential. Our team helps you determine the best injection method for your target drug delivery needs, whether it be subcutaneous, intramuscular, or intravenous.

Sterile fill finish

Ophthalmic Administration

Whether your drug formulation is a solution, suspension, ointment, or emulsion, our experts are here to aid your development program from clinical phases to commercialization. Our team prioritizes sterility and microbe-resistance while also keeping scalability top of mind.

Refine Drug Product Manufacturing and Delivery

Developability assessments
Enteric protection
Excipient selection
Process compatibility

Developability assessments

Strengthen your next study with critical data from developability assessments. Exclusively designed for early-stage molecules, this stage assesses the primary sequence for chemical liability, solubility and viscosity screening, thermal stability assessments, and propensity for self-association.

Enteric protection

Control drug product release with protecting enteric coating. These coatings inhibit the release of the drug in low pH environments, where they are more vulnerable to degradation and agglomeration.

Excipient selection

Commonly used excipients to improve oral dosage and targeted delivery offer advantages in predictability, cost, and access. Some examples include HPMC, HPMCP, HPMCAS, and EUDRAGIT.

Alternatively, we offer specialty excipients to improve process reliability, reduce cycle-times, and fortify functionality. These excipients are manufactured by our team and distributed globally by Evonik Corporation as PlasACRYL® and MarCoat™.

Process compatibility

Process-related unknowns and contaminants have the potential to decrease chemical and physical stability in your bulk drug substance or final product. We help identify and reduce these factors to ensure active stability and lot consistency. Our studies assess the stability of your molecule with known contact materials and contaminants as well as provide the analytical tools to identify and reduce residual contaminants. These contaminants often include metals, silicone oil, oxidizers, plasticizers, antifoam agents, and host cell proteins.