Jacek Ostrowski Email & Phone Number

San Diego, Ca, Us

San Diego, California, Us

San Diego, California, Us

San Diego, California, Us

Led and improved and managed early in house manufacturing efforts of antibodies for in vivo studies. Initiated and managed assessments of antibodies for developability. Managed and led CMO selection for two antibody candidates. • Brought online antibody characterization and improved transient transfection yields to support in vivostudies. • Initiated analytic characterization and developability studies of bispecific antibodies and planned for scaled production and purification. • Initiated discussions with CMOs and established early selection criteria for their selection for two antibody candidates. • Initiated developability studies of antibodies to assess manufacturing risks.• Planned conjugation, purification, and analytical methodologies for ADC efforts.

San Diego, Ca, Us

Led a novel preclinical prodrug ADC conjugate program to increase the breath of Mabvax’s sugar epitope targeting antibodies. Led antibody scaled production, purification, and analysis in the discovery of novel sugar epitope antibodies. Led development efforts with clonal cell line development and managed CMO’s in Phase I material generation and ongoing stability studies of three Phase I candidates.Antibody • Expression (transient transfection), purification, and characterization (SEC, CEX, MS, gel, ELISA) of antibodies,bi-specifics, Fabs, and scFv. • Affinity maturation and sequence liability analysis. • Clonal cell line development of RCBs for lead candidates.• Managed CROs conducting translational studies in combination therapies using MabVax’s Phase I antibody and SOC chemotherapies.• Supported INDs, stability studies, and annual FDA fillings of one Phase I candidate. • Contributed to the elucidation of the MOA of novel sugar targeting antibodies. ADC and RIT• Initiated a matrix managed preclinical ADC program based on a prodrug approach that included CRO synthesis of small molecule components. • Established purification methods for conjugates and recombinant proteins via GE AKTA and START systems.• Established SOPs for ADC characterization including HPLC (SEC and HIC), ELISA, SPR, and MS. • Testing of antibody dye conjugates using FACs based techniques for lead antibody candidate selection.• Managed CMOs for the manufacture of ADC components. • Managed CMOs for just in time manufacture of radio labeled clinical compounds for Phase I studies.• Reviewed batch records and generated CoA’s for clinical materials.• Supported INDs, stability studies, and annual FDA fillings of two Phase I candidates.

Established an antibody analytics’ department at Sevion Therapeutics to help select preclinical candidates. Led projects and scientist teams up to 3 scientists and RA’s to improve antibody and cow antibody protein yields by establishing new cell lines and new vector constructs. Led large scale antibody production for in vitro and in vivo projects. Was instrumental in the production of antibodies for autoimmune disease and oncology targets. Achievements: • Established antibody characterization including SEC, HIC, IEX, RP, DSC, DSF, SDS-Page, ELISA, western, and MS that led to the selection of Sevions’ lead preclinical candidate, SVN-001.• Led efforts for transient transfections culture growths, greater than 3 L flasks; and the purification and secondary purification of antibodies for in vitro and in vivo studies that led to the selection of Sevions’ lead preclinical candidate.• Improved purification capabilities that led to the ability to purify up to 60 to 80 antibody candidates per day from culture flasks up to 1 L.• Established capabilities that led to the fast growth and analysis screen of multiple candidates to move forward potential drug candidates.• Improved protein yields in transient transfections from 5-10 mg/L to greater than 60 mg/L through plasmid optimization and cell selection.• Established and optimized high through put growth of antibody candidates with transient transfection of suspension cells in 96 well format for improved yield and increased screening capabilities for GPCR candidates.• Initiated Antibody-Drug-Conjugation production and characterization for possible collaborations with industrial partners for oncology targets. • Led Chimerasome, HBV cages, production, and purification for a pharma collaboration.

Managed food production for brand and off label products. Introduced GMP practices into production. Worked heavily in business development to increase customer base for labeled and copcaking products. Managed up to 15 production members and managers.

Founder and lead scientist for the discovery of LPS removal from protein grown in bacteria. Patented a novel chemical method for the removal of LPS. Business development experience in establishing partnerships for promoting the use of this new technology.Achievements: • Developed a chemical based technology for the removal of endotoxin from protein solutions which lead to the filling of three patent applications.• Established collaborations with biochemical companies to test and evaluate potential applications of endotoxin removal technologies.• Initiated marketing of the LPS removal system through direct contacting and through targeted marketing.

Designed and implemented research directions for a novel based viral siRNA delivery system. Used a synergistic approach to optimize the efficacy of the delivery system by working with in vitro and in vivo teams. Led projects and scientist teams up to 10 scientists and RA’s to design, synthesize, and characterize the VLP based siRNA delivery system using multiple instrumentation techniques. Utilized knowledge in chemistry to perform novel conjugations of proteins to small molecules as well as other proteins. Achievements:• Created and established novel characterization techniques to determine purity and physical characteristics of the novel macromolecular viral based siRNA delivery system using light scattering and size exclusion methodologies that led to multiple preclinical candidates and patents.• Delivered custom macromolecular viral based siRNA therapeutics to numerous industrial tech partners for preclinical in vitro and in vivo analysis. • Developed techniques for the lipid coating of assembled capsids that were targeted with antibodies for preclinical studies of B-cell malignancies with biopharmaceutical collaborators.• Was integral in the delivery of the surface decorated viral based drug delivery system with peptides, proteins, and antibodies for preclinical in vitro and in vivo studies.• Managed scientists and RA’s to achieve critical milestones on time.

Ph.D, Chemistry

B.S, Chemistry