Elevated Access & Analytics
Through a comprehensive quality assurance system, we ensure the highest quality of services at levels, from GLP to GMP. We offer analytical and formulation services from development phase, where we support your efforts with versatile and tailor-made services; all the way to and beyond commercialization, where we offer services in GMP compliance in dedicated facilities with full QA involvement.
Meeting Stringent Compliance with Data Integrity
KBI Biopharma operates all projects under stringent cGXP compliance, ensured with digital operations at every step through Electronic Lab Notebooks (ELN), Laboratory Information Management System (LIMS), and Manufacturing Execution System (MES). Digitization assures operational excellence of lab procedures is consistently performed under high industry standards with high level data integrity, traceability, and documentation. Our compliance and quality digital system secures the highest quality from sample submission all the way to the final report.
GMP-Accredited Services
KBI Biopharma has received GMP accreditation for several analytics and formulation methods. Our GMP-compliant analysis is performed using qualified, state-of-the-art instruments and meticulously developed and comprehensively validated methods. Full GMP documentation and supervision by Quality Management enable us to deliver comprehensive analytics data packages and generate supportive data for market approval.
Specialized GMP-Compliant Techniques
KBI Biopharma offers many of its services under full GMP compliance and we are constantly adding new services and analytical techniques to our GMP portfolio. Here are some prominent examples of our GMP Analytical expertise, that we offer up to BSL2:
- Binding Assays
- Characterization, including GMP Analytical UltraCentrifugation
- Chromatography
- iCEF and CE
- Mass Spectrometry
- Microbiology
- Particulates
- and more
