Lecture 2.pdf - Cell Culture Process for Recombinant Protein Production Lecture 2 Process and Product Development by Sadettin S Ozturk Ph.D Sadettin S

Lecture 2.pdf - Cell Culture Process for Recombinant...

This preview shows page 1 - 5 out of 38 pages.

Sadettin S. Ozturk, Ph.D. Cell Culture Process for Recombinant Protein Production Lecture 2: Process and Product Development by Sadettin S. Ozturk, Ph.D 1 1 Sadettin S. Ozturk, Ph.D. Outline Overview of process and product development Monoclonal Antibody development as an example Cell line development Host, vectors, transfection process Selection of high producing clones Cell line stability Media development Evolution of cell culture media (from serum containing medium to chemically defined media) Elements of the cell culture medium Media preparation Bioreactor process development Process optimization Process scale-up 2 2
Image of page 1
Sadettin S. Ozturk, Ph.D. Drug Product Development and Commercialization Process 3 Review Approval Reg. Filing Phase III Clinical Trials Submit BLA Early Clinical Development Phase II Clinical Trials Manufacturing Activities Late Clinical Development Clinical and Product Development Activities Ph I Batch Process Validation Launch Preparation Year -2 Year 1 Year 2 Year 3 Year 4 Year 5 Preclinical Studies Target Research Phase I Clinical Trials Submit IND BLA Prep Tox Mat Ph II Batch Ph III Batch Process Development Activities Process Characterization Late Phase Process Dev Early Phase Process Development Tech Transfer BLA Prep Support Year 0 Year 6 IND: Investigational new drug application (first in human) (Clinical Trial Application, CTA in EU) BLA: Biologics license application (Marketing Authorization Application, MAA in EU) 3 Sadettin S. Ozturk, Ph.D. Process Development Clinical Identify Molecular Target Create New Discovery Research Molecular Entity Initiate Clinical Trials Cell Line Development Media Development Bioreactor Process Development Develop Purification Process Make Clinical Supplies Develop Formulation Steps in Product and Process Development 4 4
Image of page 2
Sadettin S. Ozturk, Ph.D. Discovery Research: Indentifying Molecular Targets Target proteins are identified through an extensive research in medical institutes, companies, hospitals, and research centers Samples from patients, genomic information, molecular modeling, etc are utilized Functionality of these target proteins are tested in vitro and in vivo studies Mechanism of action, bioactivity, toxicity, pharmacokinetics, bio-distribution profile are addressed before a target molecule is considered for process development 5 5 Sadettin S. Ozturk, Ph.D. Designing a DNA Sequence for the Target Protein is a Straightforward Process The protein sequence of the target molecule is determined Based on protein sequence, the corresponding RNA and DNA sequence is determined Codon optimization is widely utilized in the design the nucleotide sequence to enhance expression The DNA sequence from this process is called cDNA (complementary DNA) and it is the key for the expression of protein in cell culture cDNA is then used to transfect the cell host and express the protein in cell culture 6 6
Image of page 3
Sadettin S. Ozturk, Ph.D.
Image of page 4
Image of page 5

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture

  • Left Quote Icon

    Student Picture