일자

시간

강의주제

10/11

(수)

09:00-09:05

Welcome Address

       09:05-12:30

CMC Regulatory Challenges For Biologics Are Different

생물학적 제제 CMC 인허가의 특별한 문제들

-Understanding the terminology landscape used in our industry: biopharmaceutical, biosimilar, CGTP/ATMP

-Biopharmaceuticals are not chemical drugs – regulatory compliance consequences of the CMC differences

   12:30-13:30

                                      Lunch

       13:30-17:00

How to Develop an Effective Corporate Risk-Managed CMC Regulatory Compliance Strategy For Biopharmaceuticals

바이오의약품을 위한 효과적인 위해성 기반 CMC 인허가 전략 개발 방안

-2 major forces that shape the corporate CMC strategy

-5 essential elements of an effective CMC strategy

Critical Importance of Biological Functional Activity Measurement (Potency)

생물학적 기능 활성 측정의 중요성

-Functional assay landscape: bioassay, surrogate assay, assay matrix

-Phase appropriate application

일자

시간

강의주제

10/12

(수)

       09:00-12:30

Applying a CMC Risk-Managed Control Strategy Throughout the Entire Biopharmaceutical Manufacturing Process

바이오 의약품 제조 공정 전반에 걸쳐 CMC 위해성 기반 관리 전략 적용하기

-A walk through the entire biopharmaceutical manufacturing process – from clonality of the master cell bank through production

       12:30-13:30

                                      Lunch

       13:30-17:00

Applying a CMC Risk-Managed Control Strategy Throughout the Entire Biopharmaceutical Manufacturing Process (continued)

바이오 의약품 제조 공정 전반에 걸쳐 CMC 위해성 기반 관리 전략 적용하기 (계속)

-A walk through the entire biopharmaceutical manufacturing process – from production through purification of the API, on to the manufacture of the drug product

Major Challenge of Demonstrating Biologic Product Comparability After Manufacturing Process Changes

제조 공정 변경 후 생물학적 제제의 동등성 입증시 주요 과제

-Change is inevitable – the 3 components of comparability demonstration

-‘Future’ comparability (comparability protocols) – ‘Extreme’ comparability (biosimilars)