Manufacturing & Blinding

Delivering to your timeline with expertise and automation

Covering virtually all dosage forms, we provide a comprehensive, full-service, and vertically integrated operation for clinical trial materials preparation in support of Phase I through Phase IV studies. Our clinical supply services are cGMP compliant and include established clinical trial material and material management SOPs with QA oversight.

As one of the most respected pharmaceutical contract manufacturing services in the clinical trial phase of development, our clinical supply services team is able to adapt quickly to your needs, providing innovative, customized solutions in:

• Technology transfer
• Over-encapsulation
• A wide range of analytical and testing services in tandem with packaging

Catalent Benefits

Our blinded studies are state of the art, with numerous benefits:

• Cutting-edge technology: blinding of oral solid dosage forms into hard gelatin 
• Versatility: over-encapsulation is suitable for a huge variety of oral solid dosage forms
• Efficiency: blinding of all visible aspects achieved in one step
• Creativity: several combinations possible
• Reliability: sufficient dissolution with proper selection of backfill material
• Cost-effective: large quantities manufactured in short production time due to fully automatic process

Catalent Capabilities

Our clinical manufacturing professionals employ innovative solutions and proven processes to ensure that your timelines are achieved:

• Global procurement and deblistering of comparator drug products
• Fully automated over-encapsulation of tablets, capsules, pellets, and other solid dosage forms in various combinations
• Multi-product over-encapsulation 
• Blending and granulation capabilities 
• High-speed active and placebo capsule manufacturing 
• 100% check weighing of all capsules 
• Customized fills
• Microbiological testing, release testing, and stability testing 
• Tablet manufacturing, including matching placebo tablets
• Over 25 secondary packaging suites

Facilities

With uniform systems and facilities in the US, UK, Germany and Singapore - and an extended network of over 60 audited depots - our capacity enables us to adapt to and handle all your international compliance and distribution needs, ultimately reducing your turnaround time.

• Philadelphia, Pennsylvania, USA
• Mount Laurel, New Jersey, USA
• Allendale, New Jersey, USA
• Kansas City, Missouri, USA
• Bolton, England
• Deeside, Wales
• Schorndorf, Germany
• Singapore