E coli recombinant dna products manufacturing process

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E. coli
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Recombinant DNA products manufacturing process 11 Multi-step manufacturing process 1. Cell line genetic cloning and selection 2. Upscale (= fermentation) 3. Downscale (= purification) 4. Formulation 5. Fill and finish Cell lines Prokaryotic (e.g. E. coli) Eukaryotic (e.g. Chinese Hamster Ovary)
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12 Milestones in medical biotechnology Conclusions Biotechnology in medicine Achievements, paradigm shifts Current trends and research
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Important therapeutic fields of recombinant DNA products 13 Endocrinology Cardiology Ophtalmology Infectious diseases Transplantation medicine Haematology Intensive care Asthma Oncology Inflammatory bowel diseases Neurology Psoriasis Rheumatology Autoimmune diseases
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ENDOCRINOLOGY Insulin 14 From the 1920’s insulin was derived from porcine / cattle pancreas for therapeutic use (organotherapy) 1982 first recombinant insulin on the European market 2014 multiple recombinant insulin products on the market Rapid-acting Short-acting Intermediate-acting Long-acting Pre-mixed
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ENZYMES Gaucher’s disease and imiglucerase 15 Gaucher’s disease lysosomal disease deficit of the enzyme glucocerebrosidase accumulation of glucocerebrosides autosomal recessive trait Therapy of Gaucher’s disease enzyme substitution therapy e.g. imiglucerase
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Pompe Disease Muscle weakness, atrophy Alpha glycosidase deficiency Autosomal recessiv
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Source: International Society for Mannosidosis & Related Diseases
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Monoclonal antibodies (abbreviated as mAbs) 18 „… like a key in a keyhole TARGETED TARGETED THERAPY THERAPY „bind to a corresponding antigen in a highly specific manner…” Schneider, Curr Pharm Biotechnol., 2008
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Monoclonal antibodies mechanism of action 19 antagonism apoptosis CDC ADCC transporter Complement dependent cytotoxicity Antigen dependent cellular cytotoxicity Lutterotti & Martin, Lancet Neurol, 2008
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ONCOLOGY Trastuzumab 20 Conventional chemotherapy like „carpet bombing” –> frequent adverse events Monoclonal antibodies (mAbs) targeted therapy better outcomes less adverse events An example from oncology: Trastuzumab indication: HER2 positive metastatic breast cancer HER2 is a type of growth factor receptor HER2 positive histology: in approx. ¼ of the cases trastuzumab targets HER2 and kills cancer cells Source: Herceptin®, European Public Assessment Report
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ONCOLOGY + AUTOIMMUNE DISEASE 21 CD20 antigen present on mature B cells not present on pre-B cells and plasma cells B cells are key players in immune responses more specifically in humoral immunity Rituximab monoclonal antibody (mAb) targeting CD20 with high specificity, and depletes B cells Indications of rituximab Oncological diseases non-Hodgkin’s lymphoma chronic lymphocytic leukemia Autoimmune diseases rheumatoid arthritis specific types of vasculitis Source: MabThera®, European Public Assessment Report
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AUTOIMMUNE DISEASE 22 Etanercept fusion protein Fc part of a mAb + 2 pieces of TNF-receptors targeting TNF-alfa TNF-alfa cytokine plays important role in inflammatory processes
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