Services Shaped Around Your 360° Drug Product Needs
De-risk your drug product development and manufacturing in the safe hands of the people powering biologics.
Our drug product development and manufacturing services offer you:
Leading-edge technology, facilities, and equipment
Established in-house analytical services with proven rapid turnaround times including particle investigations to address unforeseen events
Regulatory experts highly skilled in compiling CMC dossiers in addition to preparing responses to questions from health authorities globally
Our State-of-the-Art Drug Product Services:
• Comprehensive Early and Late-phase Development Services, Including BLA-enabling Services
• Drug Product Manufacturing – at Clinical and Commercial Scales (liquid/lyo, vials/PFS)
Development services
• Biologics Candidate Selection / Formulatability Studies
• Drug Product Analytical Development
• Drug Product Formulation Development
• Drug Product Process Development
Analytical services
• Forensic Analytical Services
• Extractables and Leachables Testing
• Container Closure Integrity Testing
• Clinical in-use Compatibility Studies
• QC Release & Stability Studies
Need more information?
White paper: learn about a holistic development strategy driven by a well-defined target product profile.
