Downstream Process Development

Downstream Process Development

Providing expertise in process development for protein purificationPurification of proteins for discovery and developmentDevelopment of purification processes suitable for GMP manufactureScientific oversight of downstream manufacturing activities outsourced to external partnersProviding expertise in virus clearance and virus safetyContributing to relevant sections of regulatory documentationResponsible for virus clearance and process characterization strategy for ph III… Show more Providing expertise in process development for protein purificationPurification of proteins for discovery and developmentDevelopment of purification processes suitable for GMP manufactureScientific oversight of downstream manufacturing activities outsourced to external partnersProviding expertise in virus clearance and virus safetyContributing to relevant sections of regulatory documentationResponsible for virus clearance and process characterization strategy for ph III and registration Show less

Chemical Development Materials responsible with responsibility for Safety and Risk evaluation of new raw materials and new use of raw materials- Risk Evaluations-Justification of Specifications-Specification setting-Control Strategies-Change Control

Diabetes Purification Development-Development of processes for purification of synthetic peptides-Analysis of synthetic peptides by HPLC-Materials responsible as detailed above

Biopharm Downstream Development & Virology-Providing expertise in Virus clearance evaluation of protein purification steps for new products-Process challenge of protein purification steps for new hemophilia produtcs-Development of mAb platform with respect to virus clearance-Protocol writing and reporting of studies according to GLP-Collaboration with CRO's -Responsible author of Adventitious Agents Safety Evaluation in CTA's-Virus clearance evaluation of… Show more Biopharm Downstream Development & Virology-Providing expertise in Virus clearance evaluation of protein purification steps for new products-Process challenge of protein purification steps for new hemophilia produtcs-Development of mAb platform with respect to virus clearance-Protocol writing and reporting of studies according to GLP-Collaboration with CRO's -Responsible author of Adventitious Agents Safety Evaluation in CTA's-Virus clearance evaluation of UV-treatment of raw-material Show less

Protein Purification Technology-Purification and analysis of different coagulation factors, mAbs and fAbs by use of different chromatographic methods and equipments.-Hands on experience with protein analysis using: SDS-PAGE, SEC-HPLC, IEX-HPLC and LC-MS-Development of downstream processes for separation of Gla-forms-Development of analyses for Gla-forms.

Biopharm Downstream Development & Virology-Providing expertise in Virus clearance evaluation of protein purification steps for new products-Process challenge of protein purification steps for new hemophilia produtcs-Development of mAb platform with respect to virus clearance-Protocol writing and reporting of studies according to GLP-Collaboration with CRO's -Responsible author of Adventitious Agents Safety Evaluation in CTA's

Biopharm Manufacfuring Development API Support-Providing purification expertise to the FVIIa down-stream process.-In charge of several troubleshooting tasks including CAPA investigations in relation to the FVIIa down-stream process.- Providing understanding of principles used for the purification of Gla-proteins and development of purification processes.- Providing knowledge on the principles for activation/degradation of serine proteases/coagulation factors- Support to… Show more Biopharm Manufacfuring Development API Support-Providing purification expertise to the FVIIa down-stream process.-In charge of several troubleshooting tasks including CAPA investigations in relation to the FVIIa down-stream process.- Providing understanding of principles used for the purification of Gla-proteins and development of purification processes.- Providing knowledge on the principles for activation/degradation of serine proteases/coagulation factors- Support to new manufacturing site for rFVIIa-Responsible for comparability testing of the new and existing site for rFVIIa manufacture.-Process development for a new rFVIIa analogue.-Scientific input to Process Performant Qualification and Process Validation-Work on SPR-technology (Biacore) for surveillance of stability of proteins in solution and measurement of titer in cell harvest and evaluation of binding constants during different conditions. Show less

-Responsible for analyses of API by Immuno Chemical analyses (CIE, CRIE, RIE, RID, ELISA and LIA) and protein characterization methods (BCA and SDS-PAGE)-Responsible for standardization of API, based on Immuno Chemical analyses.-Significant contribution to a major upgrad of LIMS in the laboratory