Formulations are developed based on pre-formulation assessments of compound properties, problem statement definitions, and excipient compatibility studies. We have extensive formulation experience and expertise across a full range of enabling technologies and solid oral dosage forms:
We also develop formulations for inhalation drug delivery using our spray-dried particle engineering expertise.
Capsugel’s integrated product development sites are equipped with a full range of formulation development and process analytical capabilities, including:
Fully equipped pilot plants for formulation development include the equipment needed for proof-of-concept assessments through clinical trial manufacture for a full range of oral solid dosage forms.
Our unique combination of science and engineering expertise is core to our offering at each stage of a product’s development and manufacturing cycle. Our model is flexible and we tailor our services and products to customers’ specific needs. We supply micronized API, drug product intermediates based on spray-dried dispersion and other technologies, fit-for-purpose capsules, and finished dosage forms for clinical trials and commercial supply.
Integrated product design, development and manufacturing sites supporting the biopharmaceutical industry are located in the US and Europe. These FDA / MHRA accredited sites currently manufacture more than 40 finished commercial biopharmaceutical products. Our product development teams draw on more than 70 years of collective experience in formulation, clinical trial material and commercial manufacturing experience.
Capsugel engineers have designed and developed innovative equipment and processes to support our biopharmaceutical customers. Specialized lab-scale equipment is in place to support feasibility studies with minimal API requirements. Phase-appropriate equipment, augmented by science-of-scale studies, facilitate rapid and efficient scale-up. Proprietary equipment provides exceptional process efficiencies and productivity at commercial scale.
Our infrastructure includes lab-, pilot-, and clinical-scale manufacturing across the product development cycle using a wide range of technologies, formulation approaches and finished dosage formats. Both non-GMP and GMP facilities with separate clean rooms are in place to support our early development and clinical / commercial production, respectively. Isolation capability is in place to accommodate the development and manufacture of highly potent APIs to OEB 4-5. Primary and secondary packaging is available, and we can manage the distribution and logistics of clinical trial material for our customers.