생물제제 개발의 최적화

조기 단계에서의 처방과 생산 관계를 관리하고 안정성, 가공, 생산에 관련된 과제를 극복하며, 목적에 부합하는 의약품 개발로 연결하기 위해

1월 9일∼10일

이 부회는 생물제제 처방에 관련된 최신 동향과 과제를 다루며, 조기 제제처방과 캐릭터리제이션에 의한 개발 기간의 단축, 안정성에 관련된 과제의 극복이라는 테마에 초점을 맞춥니다. 또한 조기 제제처방과 캐릭터리제이션, 스크리닝, 응집에 관련된 과제의 극복, 유효한 해석 방법의 활용, 기술 이전 관련 과제에 대한 대처, 실험적 설계와 High-throughput 원칙의 이용이라는 테마에 관한 상세한 사례연구 및 토론도 예정되어 있습니다.

제제 개발 최적화를 위한 전략

Increasing Formulation Knowledge Space Leveraging Automation

Jamie Moore, Ph.D., Associate Director and Senior Scientist, Early Stage Pharmaceutical Development, Genentech

Solidification of Protein Solutions Using Clathrate Hydrates as a Potential Stabilization Tool

Evgenyi Shalaev, Ph.D., Associate Research Fellow, Pharmaceutical Development, Pfizer

Effectively Transitioning Early Phase Formulation Development to External Partners

Kendall Kessler, Head, Business Operations, Senior Principal Scientist, Biotherapeutics Pharmaceutical R&D, Pfizer

Improving Vaccine Development: Empirical Approaches vs. Rational Design

Manmohan Singh, Ph.D., Global Head, Vaccine Formulation Science, Novartis Vaccines

Optimizing Vaccine Formulation Development

Dominique Lemoine, Ph.D., Director, Head of Formulation Development, R&D, GSK Biologicals

안전성 문제의 파악과 극복

Overcoming Stability Issues and Successfully Completing Technology Transfer

Daniel Adams, Executive Chairman, Protein Sciences; Founder, Biogen

Understanding Underlying Principles of Protein Degradation Pathways and Their Impact on Formulation Design Space

Sharon Gao, Ph.D., Principal Scientist, Protein Sciences, aTyr Pharmaceuticals

Bioavailability and Activity of Low Viscosity, Ultra-High Concentration Nanoparticle Antibody Dispersions

Jennifer Maynard, Ph.D., Assistant Professor, Chemical Engineering, University of Texas at Austin

제제 스크리닝과 최적화

High-Throughput Profiling of Therapeutic Proteins for Developability Assessment

Kapil Gupta, Ph.D., Research Investigator III, Integrated Biologics Profiling, Novartis Pharma

Miniaturized Developability Assessment of High Concentration Antibody Formulations

Sylvia Kiese, Ph.D., Formulation Scientist and Galenical Project Manager, Formulation Research Biologics & Parenterals, F. Hoffmann-La Roche Ltd

High-Throughput Screening Implementation and Accelerated Stability Studies Utilization

Speaker to be Announced

High-Throughput Screening Methods for Formulation Development of Biotherapeutics and Vaccines

Fernando Ausar, Ph.D., Senior Scientist, Bioprocess Research and Development, Sanofi Pasteur

Novel Nanoformulation of Polymyxin B, a Peptide Antibiotic

Israel (Rudi) Rubinstein, M.D., Professor of Medicine, University of Illinois at Chicago