Luca Romagnoli, Ph.D. Business Development Manager

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1 Modelli innovativi di produzione per lo sviluppo di un processo altamente qualitativo di farmaci biologici Luca Romagnoli, Ph.D. Business Development Manager

2 BIOLOGICAL DRUGS - SOURCES Monoclonal antibodies Products from cells Recombinant proteins Tissue engineering Cells and tissues as products Cellular therapy

3 TEAM DEFINITIONS BIODRUGS «a substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological drugs include antibodies, interleukins, and vaccines» US National Cancer Institute for Health ADVANCED THERAPY MEDICINAL PRODUCT «Advanced therapy medicinal product means any of the following medicinal products for human use: a gene therapy medicinal product a somatic cell therapy medicinal product a tissue engineered product» REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT

4 API AND BIOTECH API DEFINITIONS API: «Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product... Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.» Volume 4 GMP - Part II - Glossary BIOTECH API : The term biotechnological process (biotech) refers to the use of cells or organisms that have been generated or modified by recombinant DNA, hybridoma or other technology to produce APIs. The APIs produced by biotechnological processes normally consist of high molecular weight substances, such as proteins and polypeptides Volume 4 GMP - Part II Chapter 18

5 BIOLOGICS SIZE COMPARISON x30x1500 Aspirin: 0,7 nm IgG: ~20 nm Eukaryotic cell: ~30 µm

6 BIOLOGICAL DRUGS - STRENGHTS High specificity for the target - e.g. Monoclonal antibodies have high affinity - possibility of multiple rounds of optimization Advanced biological functions - immunization, signaling, carriering Functionalization is possible to enhance functions - radioisotopes, toxins, cytokines Personalized drugs are possible

7 BIOLOGICAL DRUGS - CHALLENGES High cost of production compared to chemical synthesis Risks of viral contamination (carried by mammalian cells and reagents of biological origin) Full characterization is difficult with current methods Highly perishable Poor systemic distribution compared to small molecules Hematoencephalic barrier prevents delivery to CNS Adverse events often unpredictable before human studies Current animal models have limitations in testing complex biological functions (especially immunological drugs)

8 THE DRUG DEVELOPMENT PATHWAY Tech transfer from Research to Development Production of consistent batches for Preclinical Studies Transfer into GMP Manufacturing, QC analysis, fill and finishing, lot release in GMP Screening and recruiting of patients for clinical trial(s) Phase Pre-clinical Clinical trials Large scale Development stage R&D Phase 1 Phase 2 Phase 3 Market

9 DRUG DEVELOPMENT THE VALUE CHAIN Drug discovery Pre-clinical Clinical trials Development stage R&D Phase I Phase II Phase III Value Value / costs Development costs Stage

10 PRODUCTION OF RECOMBINANT PROTEINS Bioinformatics study on protein properties Choice of suitable host DNA codon optimization Gene synthesis Cloning in expression vector Trasformation/ transfection and screening Formulation / Filling of product Scale-up in bioreactor Set-up of purification strategy Fermentation / small scale culture

11 EXPRESSION SYSTEM CHO CELLS HISTORY Isolated by T.T. Puck in 1957 at University of Colorato First drug produced in CHO approved in 1987 (tpa) APPLICATIONS Most common mammalian cell for biologics production Monoclonal antibody and recombinant proteins More than 30 biologicals on the market are produced in CHO (and 4 out of 5 top sellers) SPECIAL POWERS Very robust in several culture conditions and bioreactors DHFR- mutants enable the generation of industrial clones The cells can grow in suspension

12 ICH Q5D CELL LINES

13 ICH Q5D Rationale for testing cell substrate Cell substrate can severly affect product quality Cells can be source of viruses Requirements Origin, source and history of the cell line Processing and generation of the cell substrate Cell banks system: establishment, testing and maintenance

14 ICH Q5D CELL LINE HISTORY Common challenges Cell have been manipulated in several laboratories History of the cell line have been lost or poorly documented Reagents were not certified Unknown donor

15 ICH Q5D GENERATION OF THE CELL SUBSTRATE General principles for cell line characterization Several methods could have been used describe all the techniques and the reagents involved Each manipulation should be documented as it contributes to the history of the cell line If the cells are transfected, foreign DNA must be described and tested (ICH Q5B) GMO risk assessment (if applicable)

16 ICH Q5D CELL BANKING SYSTEM Two-tiered system Master Cell Bank Working Cell Bank Production

17 ICH Q5D CELL BANKING SYSTEM Two-tiered system Master Cell Bank Working Cell Bank Verify consistency of the process at a different scale Production

18 ICH Q5D Cell banking system description Established procedures that regulate the cell banking system Type of ampoules and closure system Methods of preparation and analysis Cryoprotectants Conditions for storage, stability study Procedures to prevent cross-contaminations (documentation, labelling, tracking)

19 ICH Q5D TESTING OF CELL BANKS Identity Determine that the cells are what they are stated to be - Isoenzyme analysis, cytogenetics, expression of desired product Purity Free from adventitous agents and other cellular contaminants - Bioburden, mycoplasma, viruses (ICH Q5A) Stability Consistent production and retention of capacity to produce - Product analysis, DNA sequence analysis, metabolites profile Tumorigenicity Important for products containing living cells (Advanced Therapies)

20 QUALITY IS A MUST Quality is ensured by testing and rejecting batches that fail to meet its stated quality. A guiding principle for the Biotech industry is that the process is the product. Quality By Design concept: This design incorporates knowledge of the product and the process to ensure all critical quality parameters are adequately controlled

21 SCALE UP PITFALLS? Deep process uderstanding is essential for a safe scale up The cells always run the show

22 SCALE UP PITFALLS? GLYCOSILATION

23 WHEN TO COMPROMISE? Cost Purity Yield Potency

24 HOW THE PROCESS AFFECTS QUALITY Establishment of Master cell bank Sequence of cdna Type of vector/plasmid Accessory DNA elements Type of host cell Technique of transfection Propagation of host cell clone Establishment of Working cell bank Maintenance of production cultures Composition of culture medium Type of culture vials/bottles Type of fermenter/bioreactor (volume) Extraction and purification Type of purification media Number of purification steps Viral reduction Analysis of product Formulation IMPACT ON PRODUCT PROPERTIES

25 THE QUALITY IS BUILT INTO THE PRODUCT BY THE PROCESS Well established and documented cell line Medium formulation development, all GMP reagents Choice of bioreactor and production process Screening of candidates Expansion Viral characterization of MCB and WCB Vector design and clone generation Master Cell Bank Production and purification Analysis of End Of Production Cells Analysis of Bulk Harvest Rational vector design Complete documentation of cloning process Fill & Finish of final doses Aseptic process validation (media fill) Validation of viral removal/inactivation during downstream

26 LARGE SCALE PRODUCTION IN DISPOSABLE BAGS A cost-effective and high-quality manufacturing Cell Bank Small scale culture Inoculum preparation Production with parallel bioreactors, 25 L each MODULAR PRODUCTION High and reproducible quality of material and fine control of process Maximum flexibility and cost effectiveness at each stage of drug development SINGLE-USE BAGS No cleaning validation No cross contamination Continuous and effective use of production facility Reduced utilities and personnel

27 CASE STUDY - PRODUCTION IN E.coli PROCESS OUTLINE Production with parallel bioreactors, 25 L each 3x25 L productions harvested 5 times/week Total = 375 L / week Fermentation Purification Month 1 Month 2 Month 3 Month 4 = 375 L total harvest = purified material RESULTS 5000 L of fermentation Hundred-gram quantities of purified material are obtained in 4 months

28 SCALABILITY OF THE PROCESS Example of 200 L fermentation unit Bioreactors General purpose Centrifuges Medium preparation REQUIREMENTS 30 m 2 laboratory can support up to 8 bioreactors (total working volume = 200 L) including centrifuges for clarification and area for medium preparation 2 or 3 operators can run and maintain a process producing 200 L / day ADVANTAGES Lean system: no additional equipment is needed to handle 200 L volumes because of the single 25 L units Same high quality is maintained throughout the scale up from 10 L to 200 L Production can be started quickly after small scale process development without the need for further optimization Only utility required is power supply

29 THANK YOU FOR YOUR ATTENTION! areta international Via Roberto Lepetit, 34 l Gerenzano (VA), Italy l tel fax l

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