Manufacturing Footprint

A global network of eight world class manufacturing facilities, approved by international regulatory agencies, provides clinical and commercial scale manufacturing for global pharmaceutical and health & nutrition clients around the world. Dedicated non-GMP development suites are in place for pre-clinical feasibility assessments. Dedicated high containment suites are also in place to handle highly potent active ingredients to OEB 4-5 and controlled substances from pre-clinical and clinical studies through commercial manufacture. 

Capsugel's flexible manufacturing footprint support product supply throughout the development cycle across our technology platforms, inclusive of:

• Micronization / nano-milling of active ingredients
• Drug product intermediate using spray dry dispersion or hot melt extrusion technology
• Multiparticulates using melt-spray-congeal processing, fluid bed bead layering, extrusion / spheronization, or mini-tablets
• Encapsulation (powder or multiparticulates) in either capsules or sachets
• Liquid fill hard capsules or soft gels
• Tableting (immediate release, matrix, bi-layer, osmotic, chewable / orally dissolving) and coating

Primary and secondary packaging is available for clinical trial material and small-scale commercial manufacturing. Global clinical supplies distribution and logistics is also available, inclusive of cold chain capabilities, through our Xcelience Division.

Infrastructure Overview

• Eight commercial manufacturing sites in the U.S., Europe and Japan
• FDA, EMA and MHRA-inspected and accredited sites
• Co-located pharmaceutical product development and commercial manufacturing sites in Bend, OR (US); Tampa, FL (US); Ploërmel, France; and Edingburgh, Scotland 
• State-of-the-art micronization center of excellence in Quakertown, PA (US) (Powdersize Division)
• Largest commercial pharmaceutical spray drying capability in the US (Bend Research Division)
• Largest dedicated manufacturing facility for liquid-filled hard capsules (Encap Drug Delivery Division - Edinburgh, Scotland)
• Non-GMP and GMP facilities with separate clean room suites
• High containment capability to OEB 5
• Tablet, multiparticulate and capsule coating (and banding) capabilities
• Primary and secondary packaging
• Clinical supplies packaging, kitting, distribution and logistics (Xcelience Division - Tampa, FL and Birmingham, UK)

Worldwide Locations

Ploërmel, France

• Pharmaceutical market-segment focus
• Leading global manufacturer of hormone soft-gel production
• Center of excellence for steroid hormones and pharmaceutical-grade oils
• FDA and EMA inspected
• 3 best-in-class manufacturing units
  • 2 production lines for liquid-fill hard capsules (Licaps®)
  • 11 production lines for soft-gel capsules (SGcaps®)
• Versatile capability
  • Simple to complex formulations
  • High-containment processing capability for OEB-4 and -5 compounds
• Pilot and commercial manufacturing
  • cGMP and non-GMP
  • Feasibility, stability and clinical batches

 

Edinburgh, UK (Scotland)

• Pharmaceutical market-segment focus
• Global leading site in liquid-fill hard-capsule production for pharmaceutical segment
• FDA and MHRA accredited
• Co-located product development with pilot- and commercial-scale manufacturing
  • cGMP and non-GMP
  • Feasibility, stability and clinical batches
• Versatile capability
  • Simple and complex liquid and semi-solid formulations
  • Controlled substances (UK Home Office Schedule 2,3,4/III)
  • High containment processing capability for OEB-4 and -5 compounds
  • Cytoxics, antibiotics, peptides and antibodies
• Specialty capsule coating for targeted delivery
• Primary and secondary packaging

 

Bend, USA (OR)

• Pharmaceutical market-segment focus
  • Drug-product intermediates - SDDs, HME extrudates and nanocrystals
  • Multiparticulate range: extruded / spheronized beads, spray-layered multiparticulates, mini-tablets, and lipid multiparticulates (LMP technology)
  • Tablets, including osmotic and bi-/tri-layered matrices
• Co-located product development with pilot and commercial manufacturing
  • Dedicated cGMP facility for preparation of kilogram through metric ton (Phase 3) clinical supplies for all technologies
  • Commercial-scale production line for SDD drug-product intermediates
• Versatile capability
  • Solvent processing
  • High-containment processing capability to OEB-4 and -5 compounds
  • Biologics processing suite

 

Greenwood, USA (SC)

• Health and nutrition market-segment focus
• Select pharmaceutical applications
• Liquid-fill hard capsule (Licaps®) focus with annual capacity of > 800M units
• Production line for lipid multiparticulate (LMP) technology
• Co-located product development site
• cGMP sample manufacture
• Bottling and blister packaging
• JIT (just-in-time) warehousing

 

Quakertown, USA (PA)

• Particle size reduction for pharmaceutical market
  • High potency APIs
  • Controlled substances
  • APIs & excipients
• High potency milling / micronization
• 2 locations in Quakertown
  • Headquarters (40,000 ft.²)- 1 non GMP suite for R&D; 2 pilot scale GMP suites; 6 commercial scale GMP suites; 2 labs
  • 65,000 ft.² - houses a customer-dedicated suite, 1 commercial-scale GMP suite and 1 lab

Tampa, USA (FL)

• Pharmaceutical and Biotech market-segment focus (Small molecule)
  • Preformulation- Polymorph identification, salt screen/selection
  • Analytical Development Services- API characterization, analytical method development and qualification, method transfer, release and stability testing
  • Formulation Development- Tablets, capsules, oral liquid dosage forms
• Clinical and small-scale commercial manufacturing
• 4 locations in Tampa for dedicated service areas
  • Headquarters (71,000 ft.²)- 2 preformulation suites; 14 formulation development suites (4 suites dedicated to potent compounds); analytical lab
  • Dedicated cGMP and small-scale commercial CTM facility
  • Dedicated global clinical supplies and packaging facility- 2 suites dedicated to primary packaging; 7 suites dedicated to secondary packaging
  • Dedicated distribution and logistics facility

 

Colmar, France

• Health and Nutrition market-segment focus
• 3 production lines for liquid-fill hard capsule (Licaps®)
• Manufactures to European and FDA food regulations
• Co-located product development site

 

Sagamihara, Japan

• Health and Nutrition market-segment focus
• Liquid-fill hard capsule (Licaps®) focus
• Licaps® capacity of annual capacity > 400M units
• Co-located product development site

 

Related Links

Dosage Forms Solutions overview