Commercial Manufacturing

Our biopharmaceutical customers span the globe, and so does Capsugel.  We manufacture a wide range of innovative dosage forms and capsules for customers supporting every step of product development through commercialization.  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. 

Centers of Excellence provide leadership in key technologies – spray dried dispersions, micronization, and liquid-filled hard capsules - from product design through commercial scale production.

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.

Capsugel produces more than 200 billion hard capsules for approximately 4,000 customers in over 100 countries. With unparalleled depth in capsule / encapsulation technologies, we tailor the capsule design to fit specific applications and patient populations.  Our vast production capacity allows us to respond quickly and effectively to changing marketplace demands.

Capsugel supports dedicated R&D Centers of Excellence with teams of scientists and engineers continually developing new and improved products, applications, and equipment to support the biopharmaceutical industry.

At Capsugel, there’s no need to challenge us on quality. We challenge ourselves. Quality is the hallmark of our business and we strive for quality leadership in all that we do. Our high quality products, technically superior solutions and focus on both continuous improvement and service excellence mean we strive to deliver confidence in every service, capsule and finished dosage form.

Capsugel’s network serving the Biopharmaceutical industry:

Americas
  • Bend, OR, USA – Finished Product Design, Development & Manufacturing; Spray-Dried Dispersion Technology Center of Excellence; R&D center of excellence
  • Greenwood, SC, USA – Hard Capsule Manufacturing
  • Quakertown, Pennsylvania, USA – Micronization Center of Excellence
  • Puebla, Mexico – Hard Capsule Manufacturing
  • Tampa, Florida – Finished Product Design, Development & Manufacturing; Micro-Dosing / PIC Center of Excellence
     
Europe, Middle East and Africa
  • Bornem, Belgium – Hard Capsule Manufacturing; R&D Center of Excellence
  • Colmar/Strasbourg, France – Hard Capsule Manufacturing; Finished Product Design, Development & Manufacturing; R&D Center of Excellence
  • Edinburgh, Scotland – Finished Product Design, Development & Manufacturing; Liquid-Filled Hard Capsule Center of Excellence
  • Ploërmel, France – Finished Product Design, Development & Manufacturing; Soft Gelatin Capsule Center of Excellence
     
Asia-Pacific
  • Delhi, India – Hard Capsule Manufacturing 
  • Jakarta, Indonesia – Hard Capsule Manufacturing
  • Suzhou, China – Hard Capsule Manufacturing
  • Sagamihara, Japan – Hard Capsule Manufacturing; Product Development & Manufacturing