Early Clinical Projects
Raw Materials & Equipment Projects
Supported a start-up with sources for lipids and liposomes and drafted an overview of manufacture and testing.
Reviewed drawings and supplied suggestions for equipment to enhance the build-out of a biological pilot plant.
Supported a Phase 1 company with a bag manifold design allowing aseptic processing and product sampling.
Identified process equipment for cell lysis and for rapid low shear mixing.
Supplied options for testing of incoming raw materials.
Reviewed drawings and supplied suggestions for equipment to enhance the build-out of a biological pilot plant.
Supported a Phase 1 company with a bag manifold design allowing aseptic processing and product sampling.
Identified process equipment for cell lysis and for rapid low shear mixing.
Supplied options for testing of incoming raw materials.
Process Development Projects
Reviewed fermentation and expression data, and suggested modifications for increased host stability.
Designed a successful selection procedure to isolate a stable high protein production strain.
Supported a single chain antibody company with process review and modifications to ensure increased yields and more robust production for clinical material.
Analyzed data and supported the development of saleable process for purification of a clinical
antibody product.
Defined optimum chromatography resin for product purification
Designed a successful selection procedure to isolate a stable high protein production strain.
Supported a single chain antibody company with process review and modifications to ensure increased yields and more robust production for clinical material.
Analyzed data and supported the development of saleable process for purification of a clinical
antibody product.
Defined optimum chromatography resin for product purification
Clinical Manufacturing Projects
Identified the appropriate CMO for multiple BioPharm companies needing clinical material.
Supplied companies with options for Process Development and Contract Testing Labs.
Drafted Batch Records and SOPs to support manufacturing activities.
Successfully supported CMO and CTL technology transfers for multiple companies.
Supported early clinical companies with process issue resolution at CMOs.
Reviewed INDs and associated regulatory documents, supported pre-IND preparations.
Supplied companies with options for Process Development and Contract Testing Labs.
Drafted Batch Records and SOPs to support manufacturing activities.
Successfully supported CMO and CTL technology transfers for multiple companies.
Supported early clinical companies with process issue resolution at CMOs.
Reviewed INDs and associated regulatory documents, supported pre-IND preparations.