John Kumer Email & Phone Number

Seattle, Wa, Us

Lead CMC activities supporting Aptevo’s clinical development of ADAPTIR™ (bispecific antibodies) therapeutic candidates for hematologic and solid tumor indications. Guide development of phase appropriate manufacturing processes, analytical methods, and potency assays for pre-clinical therapeutic candidates. Transfer these processes and methodologies to CDMO to generate and disposition cGMP Drug Substance and Drug Product to support development of Aptevo’s new clinical programs.

Seattle, Wa, Us

Currently lead process development team's effort to develop cell culture and purification processes from clone selection through clinical manufacturing for First in Human bispecific antibody-like therapeutics (ADAPTIR™ and ADAPTIR-FLEX™).-Serve as PD lead for multiple projects involving cross-disciplinary team coordination, aid in forecasting development plans, author CMC sections of IND/IMPD. Facilitate technology transfer activities of production process to CMO, author reports, lead Process Development meetings and approve batch records. Serve as person-in-plant during clinical manufacturing.-Manage four direct reports.-Develop and scale processes to produce NHP PK and Tox material.

Seattle, Wa, Us

Contribute to purification process development projects from clone selection through clinical manufacturing for First in Human bispecific antibody-like therapeutics (ADAPTIR TM).-Serve as downstream CMC lead for multiple projects involving cross-disciplinary team coordination, aid in forecasting development plans, author CMC sections of IND/IMPD. Lead downstream technology transfer activities of production process to CMO, authoring reports, leading downstream meetings and approving batch records. Serve as person-in-plant during clinical manufacturing.-Design and execute scale down process model qualifications-Design and execute IND/IMPD enabling viral validation including CRO evaluation, tech transfer of scale down model, approval of CRO chromatography purification batch records, serve as liaison at CRO during viral spiking execution, and perform final review of CRO’s viral validation.-Manage one direct report.-Develop and scale purification processes using AKTA Pure150 and AKTA Pilot to produce NHP PK and Tox material.

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