BP403TSemester 43 creditsTheory

Pharmaceutical Biotechnology

Complete unit-wise syllabus for BP403T as per the PCI B.Pharm NEP 2020 curriculum (Semester 4 — Medicinal Chemistry + 1st Internship).

URL:https://pharmacode.in/syllabus/semester-4/bp403t-pharmaceutical-biotechnology/

Unit-wise Syllabus

5 Units

Recombinant DNA Technology9 Hours

Tools of rDNA technology: restriction endonucleases, DNA ligases, vectors (plasmids, bacteriophages, cosmids, YACs, BACs), transformation, selection
Gene cloning: isolation of genomic/cDNA, PCR — principle, components, types (RT-PCR, real-time PCR, qPCR); Southern blotting, Northern blotting
Expression systems: prokaryotic (E. coli) and eukaryotic (yeast, CHO cells, baculovirus) expression systems; inclusion bodies; protein refolding

Fermentation Technology and Downstream Processing9 Hours

Fermentation: types (batch, fed-batch, continuous); bioreactor types (stirred tank, airlift, hollow fibre); operating parameters (pH, temperature, dissolved oxygen, agitation)
Biosynthesis of antibiotics: penicillin, streptomycin, tetracycline — biosynthetic pathways and production steps
Downstream processing: cell disruption, centrifugation, filtration, extraction, chromatography (ion exchange, affinity, gel filtration), ultrafiltration; protein characterization

Monoclonal Antibodies and Therapeutic Proteins9 Hours

Monoclonal antibody technology: hybridoma technology; ELISA; RIA; applications in diagnostics and therapy (Herceptin, Rituximab, adalimumab)
Therapeutic proteins: insulin (rDNA-produced human insulin), EPO, growth hormone, G-CSF, interferons, tissue plasminogen activator (tPA) — production and clinical applications
Antibody engineering: chimeric, humanized, and fully human antibodies; antibody-drug conjugates (ADCs); bispecific antibodies

Vaccines — Production and Quality Control9 Hours

Types of vaccines: live attenuated, killed/inactivated, toxoid, subunit/recombinant, conjugate, viral vector, mRNA vaccines; principles and examples
Vaccine production: fermentation, purification, adjuvant addition, formulation; cold chain management; lot release testing
Quality control of vaccines: potency, safety, sterility testing; WHO requirements; Good Manufacturing Practice for vaccines

Biosimilars, Genomics, and Pharmacogenomics9 Hours

Biosimilars: definition, regulatory pathway (EMA, USFDA, CDSCO), comparability studies, immunogenicity concerns; marketed biosimilars
Genomics and proteomics: Human Genome Project; genomic databases; proteomics approaches — 2D-PAGE, mass spectrometry; applications in drug discovery
Pharmacogenomics: concept; genetic polymorphisms in drug metabolism (CYP2D6, CYP2C19, NAT2); personalized medicine; companion diagnostics; pharmacogenomic-guided therapy

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