BIOT115B Lecture Notes.docx - BIOT-115B BIOREACTOR CELL CULTURE TECH CRO \u2013 Contract Research Organization Target identification for this course

BIOT115B Lecture Notes.docx - BIOT-115B BIOREACTOR CELL...

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BIOT-115B BIOREACTOR CELL CULTURE TECH 04/18/19 CRO – Contract Research Organization Target identification for this course: protein mAb (monoclonal antibodies) Drug Development – is the process of bringing a new drug/medicine/therapeutic to market once a lead candidate has been identified through the process of drug discovery. 2 Stages of Drug Development: o Discovery Stage: (7-10 years) Identify target Identify compounds Establish Activity Select Clinical Candidates Test Safety During this period, µg -> mg quantities of protein are made (also known as small scale protein production) o Ex: 10mL -> 10L Small Scale Submits application for clinical trial (IND/CTX/CTA) o IND – Investigational New Drug o Development Stage: (7-10 years) Test Safety Human Clinical Trial Phase I (~10 people) o testing for safety Human Clinical Trial Phase II (~100 people) o testing for efficacy Human Clinical Trial Phase III (>100 people) o testing for how it compares to current marketed products, efficacy, application for FDA approval Human Clinical Trial Phase IV During this period, g -> kg quantities of protein are made (also known as large scale protein production) o Ex: 100L -> 100,000L Large Scale Submits registration for Regulatory Approval (NDA/BLA/MAA) o NDA – New Drug Application Small Molecule VS. Biologics o Small molecule drugs: Ex: Aspirin, Ibuprofen Made by chemical synthesis o Small/Large Molecule Biologics Small biologic Ex: Human Growth Hormone ~3,000 atoms Large biologic Ex: Monoclonal antibody ~25,000 atoms mAb (Monoclonal Antibodies) o Focal point of biologics development o Combined world-wide sales from mAbs will be ~$125 billion by 2020 o About 50 mAb approved in US and EU to treat range of diseases Ex: Avastin (bevacizumab) Metastatic Colorectal Cancer Non-Small Cell Lung Cancer (NSCLC) Glioblastoma Renal cell carcinoma More in clinical trials Ex: Keytruda (pembrolizumab) Non-Small Cell Lung Cancer (NSCLC) Advanced Melanoma More in clinical trials Biopharmaceuticals o The recent (late 1970’s) invention of recombinant DNA techonology has led to an influx of many new biopharmaceutical products into the world market o Biopharmaceuticals are drugs created through genetic manipulation of living cells or organisms o Recombinant DNA containing a gene encoding the protein of interest (POI) can be used to transfect a host organism o Host organism = mammalian cells CHO – Chinese hamster ovary cells HEK293 – Human embryonic kidney cells Hybridoma Ex: SP2/0 – mouse myeloma cells o The protein synthesis machinery of the host organism can then be used to make the protein of interest o Proteins created using recombinant DNA are called recombinant proteins Biosimilars are similar to generic drugs SP2/0 Cells o Immortalized mouse myeloma cell lines Ex: Erbitux Remicade Reopro Simulect LymphoCide
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Read article: “Fed-Batch Bioreactor Process Scale-Up” WHAT I UNDERSTAND/KNOW WHAT I WANT TO KNOW WHAT I LEARNED SP2/0 cell line Mammalian cell line Commercial manufacturing Monoclonal antibodies
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