Global Biotech Experts
Global Biotech Experts, LLC specializes in analytical and stability studies for biologically-derived therapeutic and vaccine products, offering expert consulting, training, and compliance services to biotech and pharmaceutical companies worldwide. With over 30 years of experience, they assist in designing efficient CMC strategies, ensuring regulatory compliance, and navigating complex biopharmaceutical development processes.
Industries
Nr. of Employees
small (1-50)
Global Biotech Experts
Services
CMC analytical consulting
Consulting services covering physicochemical and functional characterization, impurity control, comparability studies, method lifecycle management, stability study design, and assay development/validation.
Laboratory quality and compliance audits
Audits and gap analyses for GLP/GMP labs, Part 11 compliance reviews, data integrity assessments, remediation planning and due diligence audits for partnerships or acquisitions.
Customized CMC training and workshops
Custom in-house and public training classes on CMC analytics and stability programs, with modular content adaptable to project needs and delivery as in-person workshops or web-based webinars.
CMC analytical consulting
Consulting services covering physicochemical and functional characterization, impurity control, comparability studies, method lifecycle management, stability study design, and assay development/validation.
Laboratory quality and compliance audits
Audits and gap analyses for GLP/GMP labs, Part 11 compliance reviews, data integrity assessments, remediation planning and due diligence audits for partnerships or acquisitions.
Customized CMC training and workshops
Custom in-house and public training classes on CMC analytics and stability programs, with modular content adaptable to project needs and delivery as in-person workshops or web-based webinars.
Expertise Areas
- CMC analytical strategy and stability program design
- Analytical method development, validation and transfer
- Laboratory quality, GLP/GMP compliance and PAI readiness
- Analytical comparability and biosimilarity assessment
Key Technologies
- ELISA and immunoassays
- Immunogenicity and ADA neutralization assays
- Forced-degradation and stability-indicating methods
- Analytical method qualification, validation and tech transfer