Formulation Development & Clinical Trial Manufacturing

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

We provide a full range of development services, including analytical method development and stability testing. Specialized capabilities are in place to handle controlled substances, hormones and high-potency drug compounds.

Formulation Development

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: 

  • Micronized / nano-milled compounds
  • Drug Product Intermediates – spray-dried dispersions, multiparticulates
  • Specialized Tablets – osmotics, bi- and tri-layer matrices, orally dissolving, mini-tabs
  • Capsule or Sachet-Based Formulations – powders, granules, multiparticulates
  • Liquid-Filled Hard Capsules – lipid / solvent / co-solvent based formulations including SEDDS, SMEDDS
  • Soft Gelatin Capsules – lipid / semi-solid based formulations

We also develop formulations for inhalation drug delivery using our spray-dried particle engineering expertise.

Integrated Product Development Sites

Capsugel’s integrated product development sites are equipped with a full range of formulation development and process analytical capabilities, including:

  • Advanced imaging systems, including electron microscopy
  • Materials characterization technologies, including nuclear magnetic resonance spectroscopy
  • Advanced surface characterization techniques, including thermal analysis and particle sizing

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.

Science and Engineering Expertise

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.

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A Full Range of Support

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.

Centers of Excellence

Bend, Oregon

Capsugel’s facilities in Bend, Oregon, are home to its Center of Excellence for Spray-Dried Dispersion (SDD) Technology for bioavailability enhancement.  This enabling technology platform offers a solution to address the increasing number of drug candidates with low aqueous solubility.  With its integrated product development approach, the Capsugel-Bend team has an array of other technology offerings, such as multiparticulates and particle engineering for inhalation formulations that span the product-development continuum, from preclinical and first-in-human to late-stage development and commercial production. Learn More

Edinburgh, Scotland

Capsugel’s facilities in Edinburgh, Scotland, are home to its Center of Excellence for Liquid-Filled Hard-Capsule (LFHC) Technology.  This enabling technology platform serves a global market with integrated product design, development, and manufacturing of pharmaceutical products.  The Edinburgh facility is the largest dedicated pharmaceutical liquid and semisolid production site for LFHC technology in the world and Capsugel has an extensive record there designing and optimizing lipid, semi-solid and liquid formulations, as well as advancing compounds from feasibility through the clinic to commercialization. Learn More

Tampa, Florida

Capsugel’s facilities in Tampa, Florida, are home to one of its two Centers of Excellence specializing in Powder-in-Capsule (PIC) and Powder-in-Bottle (PIB) technology.  These enabling approaches allow customers worldwide access to micro-dosing, a superior method to deliver precise amounts of active compound in small quantities, minimizing the cost of early feasibility work and speeding time to market.  The Tampa site offers integrated product development, from early design work support to product optimization to clinical manufacture of PIC/PIB dosage forms. Learn More

Quakertown, Pennsylvania

Capsugel’s facilities in Quakertown, Pennsylvania, are home to it Center of Excellence for micronization and nano-miling of biopharmaceutical compounds. This enabling technology provides integrated product development which includes our premier particle engineering capability through micronization, with capabilities from early stage design through scale-up and commercial quantities. With over 20 years of manufacturing experience, we routinely develop robust processes at any scale of development through commercialization. Learn More