Biosimilars technology
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Biosimilars technology Syllabus — Unit-wise Content
The official GTU curriculum for Biosimilars technology (subject code 3160416) as prescribed for Biotech · Semester 6 divides the course into 3 units, covering 44 listed topics. The unit-wise breakdown below is read from the GTU syllabus document for this subject code, so you can check what the course actually covers before deciding which papers to attempt.
Download the official syllabus PDF (3160416)Unit 1 UNIT I
- Introduction to Biopharma Generics in Biopharma
- definition of biologics
- super biologics
- differences between chemical generics and biosimilars
- The developmental and regulatory challenges in biosimilar development
- Prerequisites for Biosimilar development
- Biosimilar market potential. 7 15.5
Unit 2 UNIT II
- Types of biosimilar drugs Peptides
- Nucleic acid based therapies (DNA, RNA, etc)
- Cell based therapies (including stem cells) 5 11.1
Unit 3 UNIT III
- Process pipeline for Recombinant protein biosimilar Searching for candidate biosimilar with patent search and Nucleotide database
- Choice of elements of gene of interest: Restriction Enzyme recognition sites
- kozak sequence
- start codon
- codon optimized gene sequence
- termination signal
- secretion signal
- Selecting a Vector
- cloning cassete into vector and expansion of construct
- Trasnfection in to selected host cell line (CHO, BHK, NS0, SP2/0
- Clone selection and Expansion
- Research cell bank
- Mother cell bank and Working cell bank
- Upstream optimization: Media and feed optimization, KLa, Growth characterization
- production parameters
- Downstream optimization: 14 31.1 Subject Code: 3160416 Wef 2018-19 Size exclusion
- ion exchange, HIC, mixed-mode, and affinity chromatography
- Analytics/ cGMP requirements: HCP (Host cell protein) and hcDNA (host cell DNA) determination
- End of Production Cell Bank (EPC)
- Genetic stability of cell line
- Bulk harvest testing for contaminants
- Formulation of final product 5
- UNIT IV: Bioequivalence studies Immunogenicity & allergenicity of biosimilars
- factors affecting immunogenicity -structural
- post-translational modifications
- Biological activity:antibody based and whole cell assays
- Safety studies
- manufacturing and formulation methods for biosimilars
- types of bioequivalence (average
- experimental designs & statistical considerations for bioequivalence studies (Non- replicated designs –General Linear Model
- Replicated crossover designs)
- introduction to “ORANGE BOOK” & “PURPLEBOOK”. 11 24.4 6
- UNIT V: Case studies Cell based Biosimilars
- gene therapy and CAR-T cells:Case study of KYMRIAH
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