Oral Drug Delivery of Live Biotherapeutics for First In Human Studies
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1 Oral Drug Delivery of Live Biotherapeutics for First In Human Studies Presented by Mike Frodsham Pharmaceutical Development Manager
2 About Quay Pharmaceuticals
3 About Quay Pharmaceuticals Contract development and clinical manufacturing organisation based in UK with a global customer base
4 About Quay Pharmaceuticals Contract development and clinical manufacturing organisation based in UK with a global customer base Just opened a new lab in Israel to translate some of the innovation occurring there in to our development programs to support our customers
5 About Quay Pharmaceuticals Contract development and clinical manufacturing organisation based in UK with a global customer base Just opened a new lab in Israel to translate some of the innovation occurring there back in to our development programs Formulate for small and large molecules, live bacteria and phages - for systemic and localised delivery
6 About Quay Pharmaceuticals Contract development and clinical manufacturing organisation based in UK with a global customer base Just opened a new lab in Israel to translate some of the innovation occurring there back in to our development programs Formulate for small and large molecules, live bacteria and phages - for systemic and localised delivery Known for formulation strength in targeted delivery and application of novel engineering solutions for GMP manufacture, to support our customers into clinic quickly and effectively.
7 About Quay Pharmaceuticals Contract development and clinical manufacturing organisation based in UK with a global customer base Just opened a new lab in Israel to translate some of the innovation occurring there back in to our development programs Formulate for small and large molecules, live bacteria and phages - for systemic and localised delivery Known for formulation strength in targeted delivery and application of novel GMP engineering solutions to support our customers into clinic quickly and effectively l Containment for BSL class 2 microbes
8 About Quay Pharmaceuticals Projects supported by our senior scientific team (>150 years in product development ) comprising of:
9 About Quay Pharmaceuticals Projects supported by our senior scientific team (>150 years in product development ) comprising of: Prof. M. Rubinstein (Chairman)
10 About Quay Pharmaceuticals Projects supported by our senior scientific team (>150 years in product development ) comprising of: Prof. M. Rubinstein (Chairman) Prof. J. Collett
11 About Quay Pharmaceuticals Projects supported by our senior scientific team (>150 years in product development ) comprising of: Prof. M. Rubinstein (Chairman) Prof. J. Collett Prof. L. Gifford
12 Aim Key considerations for oral live biotherapeutic product (LBP) development Critical factors which affect time-line to get to GMP manufacture of drug product Incorporation of quality requirements during development studies
13 Aim Key considerations for oral live biotherapeutic product (LBP) development Critical factors which affect time-line to get to GMP manufacture of drug product Incorporation of quality requirements during development studies Our Focus: to convert drug substance to drug product
14 Quay Considerations Regulatory
15 Quay Considerations Regulatory Manufacturing capability (GMP): MHRA IMP Licence for manufacture (MIA).
16 Development Process for Oral Live Biotherapeutic Products
17 Typical Development Process for Live Biotherapeutics Drug substance typically supplied as freeze dried powder(s) Cell Separation and Stabilisation of Biomass Fermentation Lyophilisation Encapsulation
18 Quay Considerations Drug Substance
19 Quay Considerations Drug Substance Typical Tests Reported on a Certificate of Analysis: LBT (Single Strain) Appearance Identity Confirmation Viable Cell Count Water Content Microbiological Quality
20 Quay Considerations Drug Substance Typical Tests Reported on a Certificate of Analysis: Typical Early Phase Unknowns: LBT (Single Strain) Appearance Identity Confirmation Viable Cell Count Water Content Microbiological Quality Batch to batch consistency VCC & physical characteristic changes. Processing limitations Environmental considerations & process scalability think end in mind Decontamination regimes Validation requirements, & retro plant design considerations.
21 Quay Considerations Formulation Development
22 Quay Considerations Formulation Development ph gradient Stomach Duodenum 5-7 Jejunum 7-9 IIeum 7-8 Microbial biomass cells/ml cells/ml cells/ml 10 8 cells/ml Ileocecal value Colon cells/ml Annu. Rev. Microbiol :411-29
23 Quay Considerations Targeted Oral Delivery
24 Quay Considerations Targeted Delivery Existing polymer systems can be employed: Supplier Range ph Range Evonik Eudragit 5 >7 Shin-Etsu Aqoat 5 7 Colourcon Opadry Enteric 5 7
25 Quay Considerations Targeted Delivery Existing polymer systems can be employed: Supplier Range ph Range Evonik Eudragit 5 >7 Shin-Etsu Aqoat 5 7 Colorcon Opadry Enteric 5 7 Shin-Etsu Aqoat Product Literature
26 Critical Factors Affecting GMP Time-lines
27 Critical Factors Affecting GMP Time-lines
28 Critical Factors Affecting GMP Time-lines - Drug Substance Supply & Quality Chain - GMP audit trail
29 Critical Factors Affecting GMP Time-lines - Drug Substance Supply & Quality Chain - GMP audit trail - Batch to Batch Variation - Be prepared for potency loss on scale up (drug substance and drug product)
30 Critical Factors Affecting GMP Time-lines - Drug Substance Supply & Quality Chain - GMP audit trail - Batch to Batch Variation - Be prepared for potency loss on scale up (drug substance and drug product) - Risk Assess Clinical Design - Build in flexibility
31 Critical Factors Affecting GMP Time-lines - Drug Substance Supply & Quality Chain - GMP audit trail - Batch to Batch Variation - Be prepared for potency loss on scale up (drug substance and drug product) - Risk Assess Clinical Design - Build in flexibility - Ensure Robust Analytics - Identity, potency, critical parameter analysis (including in-vitro release assessment)
32 Critical Factors Affecting GMP Time-lines - Drug Substance Supply & Quality Chain - GMP audit trail - Batch to Batch Variation - Be prepared for potency loss on scale up (drug substance and drug product) - Risk Assess Clinical Design - Build in flexibility - Ensure Robust Analytics - ID, Potency, critical parameter analysis (including in-vitro release assessment) - Drug Product Specification Setting - Get the regulators on board early fast moving landscape
33 Example: Live Biotherapeutic Drug Product Specifications
34 Example: LBP Specifications Test Appearance Identity Content Purity Disintegration Moisture Methodology Visual 16s RNA sequencing Strain specific quantification (CFU/g) Uniformity of dosage units EP Ph. Eur /13 Microbial quality Ph. Eur (media selected in accordance with ph threshold of release controlling polymer) Karl Fischer
35 Summary Prior to initiating drug product development studies Robust analytics (for drug substance) are necessary to support: Fast turnaround of results allowing efficient formulation development time-lines. Product development data essential to set specifications and infer product shelf-life. Formulation design must consider, process restrictions due drug substance sensitivity to achieve targeted delivery. Flexible clinical design to accommodate variable drug substance assay.
36 Thank you QUAYPHARMA.COM
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