Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development

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1 Host cell Protein Clearance and Detection: Critical issues for Biopharmaceutical development Protein Quantification workshop, Waters: 13 th November 2012 Vincent Monchois, R&D and Pilot Services Manager, Novasep

2 A Global Presence Seneffe and Gosselies - BELGIUM Boothwyn Shrewsbury Shrewsbury MA - USA Pompey - FRANCE Le Mans - FRANCE Seneffe Pompey Leverkusen - GERMANY Freeport Boothwyn PA - USA Freeport THE BAHAMAS Shanghai - CHINA Leverkusen S.-M.-de-Beynost Le Mans Mourenx Chasse-sur-Rhône Chasse-sur-Rhône - FRANCE Saint-Maurice-de-Beynost - FRANCE Mourenx - FRANCE Novasep Synthesis (Synthetic molecules) Novasep Process (Biomolecules) Over 100 R&D projects per year Over 100 active molecules produced per year Over 2,000 purification systems installed worldwide Shanghai Corporate Presentation 04/2012 2

3 Novasep Process: Mission and Markets Your Process and/or Manufacturing Needs R&D Novasep Process Development Pilot Scale Technical Package Novasep Outsourcing Services Novasep Equipment, Systems, Consumables Biopharma Food Ingredients Functional Ingredients Bio-Industries

4 Technologies and Competences: Focus on Biopharmaceutical applications

5 Therapeutic Biologics Products : Characteristics Products made by or composed of viable organisms Natural & rdna Proteins, mab Vaccines, Cell and Gene Therapy Blood and Blood Derivatives Majority of Biotech Products used genetically Living Cells Insert gene Specific conditions for optimal culture growth (Temp ph D02..) Complex Purification Steps Difficult to demonstrate purity, identity, potency & consistency

6 Therapeutic Biologic Products vs small Molecule drugs Complex structure and heterogeneous composition Amino acid sequence Post translational modification (glycosylation, oxidation..) Conformation Stabilities issue (i.e. aggregation, proteolysis) Complex production medium Medium components Cell components (i.e. DNA, lipids, proteins ) Complex Purification Steps Potential entry gate for diseases Infectious diseases: Viral safety (i.e retrovirus, adventidious virus) - Pyrogenic issues (i.e. endotoxin) - Allergic issues (i.e. epitopes from HCP) - Gene transfer (i.e. residual DNA) taxol mab

7 Drug Development Process Discovery Development Periapproval Research Phase I Phase II Phase III Phase IIIb Phase IV Preclinical IND Filed NDA Filed NDA Approved Investigational New Drug (IND) - Insure identification, quality, and strength of the drug Impurities, sterility (CMC) - Pharmacology/Toxicology Data New Drug Application (NDA) Increasing GMP requirements up to process and method validation

8 CMC: Chemistry, Manufacturing, and Controls Drug Substance: New Chemical Entity (NCE), Test Article, Active Pharmaceutical Ingredient (API): Material included the drug product, product-related substances, product- /-process-related impurities. Drug Product: Formulated Drug, including container and packaging

9 Safety Purity & Characterization Drug substance characterization - Well defined and controlled manufacturing process removing process-related impurities - Product-related impurities - Product substances (product variants that are active) Identity Acceptance criteria for release and stability attributes should be established Host cell protein = Process related impurity

10 ICH Guidelines: Regulatory requirement for HCP (i) ICH Q7. Good Manufacturing Practice guide for active pharmaceutical ingredients, Where appropriate, the removal of media components, host cell proteins, other process-related impurities, product-related impurities and contaminants should be demonstrated ICH Q11. Development and manufacture of drug substances (chemical entities and biotechnological/biological entities), Drug Substance Critical Quality Attributes Impurities are an important class of potential drug substance CQAs because of their potential impact on drug product safety. ( ) For biotechnological/biological products, impurities may be process-related or product-related (see ICH Q6B), ( ). (e.g., Host Cell Proteins (HCP) )

11 ICH Guidelines: Regulatory requirement for HCP (ii) ICH Q6B. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, ( ) Individual and/or collective acceptance criteria for impurities (product-related and process-related) should be set, as appropriate ( ) ( ) Process-related impurities ( ) may include cell culture media, host cell proteins, DNA, ( ). These impurities should be minimized by the use of appropriate wellcontrolled manufacturing processes. ( ) ( ) Cell substrate-derived impurities include, but are not limited to, proteins derived from the host organism ( ). For host cell proteins, a sensitive assay e.g., immunoassay, capable of detecting a wide range of protein impurities is generally utilized.

12 ICH Guidelines: Regulatory requirement for HCP (iii) ICH Q5E (quality of biotechnological product). Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process, Analytical techniques ( ) It can be difficult to ensure that the chosen set of analytical procedures for the pre-change product will be able to detect modifications ( ) Consequently, the manufacturer should determine ( ) whether or not existing tests remain appropriate ( ) For example, when the manufacturing process change gives rise to a different impurity profile in the host cell proteins, manufacturers should confirm that the test used to quantitate these impurities is still suitable for its intended purpose. It might be appropriate to modify the existing test to detect the new impurities

13 ICH Guidelines: Regulatory requirement for HCP: Conclusions PROCESS: Efficient and robust process maximizing HCP removal Individual operations characterized Target range for consistent removal CONTROLS: Appropriate analytical procedures developed and validated Sensitive Able to detect potential of change in Manufacturing process assessed (comparability) PRODUCT: Specifications set for the drug substance Lower level as possible (ng/mg product)

14 USP: Expression system and safety E. Coli Yeast CHO VIRAL ENDOTOXIN INTRACELLULAR (HCP) >> 900 mg/g Not used Not used EXTRACELLULAR (HCP) No expression 200 mg/g 100 mg/g ( ppm) HCP= 0.01 mg/g (1 ppm) to 0.1 mg/g (100 ppm)

15 DSP: Overall Strategy of Biopharmaceutical product purification DNA Endotoxine Viral HCP DNA Endotoxine Viral HCP DNA Endotoxine Viral HCP

16 Current analytical methods used for HCP detection BIOPHARM, Volume 13, Number 6, pages 38-45, May 2000 Standard method: Immunossay (ELISA)

17 HCP Quantification by ELISA: Development and Validation issue (i) Typical source: Polyclonal antibody against cell lysate of CHO cells grown in serum supplemented media Accuracy? Specificity? Precision? Robustness? Are anti-cho HCP antibodies can detect HCP in MY drug substance (?) Sensitivity?

18 HCP Quantification by ELISA: Development and Validation issue (ii) CHO Lysates Immunization Polyclonal Antibodies Are anti-cho HCP antibodies can detect HCP in MY drug substance sample (?) DETECTED BLOCKED NOT DETECTED NOT DETECTED

19 Approaches to develop and validate HCP analytical methods Test study to determine if all the HCP present in the drug substance are detected by anti-cho prior phase III validation Potential changes with production and purification procedures Develop a Product specific Immunossay Potential changes with production and purification procedures (new assay) Time and cost consuming (12 months development) Proteomics derived methods => LC/MS derived methods Accurate and Specific: Bioinformatic support Precise Robust : not subjected to Process change Sensitive: ppm range

20 Approaches to develop and validate HCP analytical methods

21 Approaches to develop and validate HCP analytical methods Accuracy of anti-cho HCP antibodies kit used since tox stage Alternative specific solutions to detect HCP for late stage/commercial stages

22 Trypsin digest followed by 2D LC/MS E approach: Digestion Spiking with rabbit phosphorylase a (PHO) as internal standard

23 Trypsin digest followed by 2D LC/MS E approach: HPLC

24 Trypsin digest followed by 2D LC/MS E approach: MS analysis

25 Trypsin digest followed by 2D LC/MS E approach: Bioinformatic analysis

26 Trypsin digest followed by 2D LC/MS E approach: HCP in Crude

27 Trypsin digest followed by 2D LC/MS E approach: HCP in F2

28 Trypsin digest followed by 2D LC/MS E approach: HCP in concentrated drug substance

29 Trypsin digest followed by 2D LC/MS E approach: Summary data

30 Conclusions:2D LC/MS E and HCP analytic development and validation for Biopharmaceutical Detection and Identification of HCP up to 1 ppm Proprietary and personal HCP data Robust and Fast but may require further optimization Data mining for Immunoassay or MRM development Immunoassay: development of dedicated or validation of the broad kit Liquid Chromatography coupled with tandem quadruple mass spectrometry (LC/MS/MS) in multiple reaction monitoring (MRM) Gives insight for USP or DSP improvement

31 Thank you for your attention!

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