The Application of Pharmaceutical cgmp to Live Bacterial Products. James Harris Business Development Manager
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1 The Application of Pharmaceutical cgmp to Live Bacterial Products James Harris Business Development Manager
2 The Objective CMC expectations of a cgmp live bacterial biopharmaceutical project
3 Overview Define Live Biotherapeutic Products (LBPs) Regulatory guidelines & expectations Quality Management Chemistry, Manufacturing & Controls (CMC) Product lifecycle
4 Live Biotherapeutic Products By Definition Are; Drug, Biological Product, Pharmaceutical, Therapeutic Drug Substance (API), Drug Product Medicines to treat specific clinical indication(s) Regulated under Drug & Medicines Acts / Legislation Are not; Probiotic, Food or Dietary Supplement Medical Device Products to confer certain health benefits Regulated under Food standards
5 Medical Products for Investigation / Treatment of a Clinical Condition In Europe; Clinical studies under a CTA License approval under a MAA Ref. 2001/20/EC. EudraLex Volumes 2A, 4 Chap 1, etc. Other Territories (eg. U.S.); Clinical studies under an IND License approval under a BLA Ref. FDA s 21CFR312 & 600. CBER, ICH, etc.
6 Medical Products for Investigation / Treatment of a Clinical Condition In Europe; Clinical studies under a CTA License approval under a MAA Ref. 2001/20/EC. EudraLex Volumes 2A, 4 Chap 1, etc. LBPs are not exempt from these guidelines Other Territories (eg. U.S.); Clinical studies under an IND License approval under a BLA Ref. FDA s 21CFR312 & 600. CBER, ICH, etc.
7 Requires a Pharmaceutical Quality System Ensure that products are fit for their intended use Protects risk to patient from inadequate; Safety Quality Efficacy GMP for Medicinal Products Quality Risk Management principles Defined, robust & graded CMC package
8 Development & Commercialisation Path Product Lifecycle Quality Management Idea R&D Toxicology Process development Clinical production Product Licensure
9 Development & Commercialisation Path Product Lifecycle Quality Management Idea R&D Toxicology Process development Clinical production Product Licensure
10 Chemistry, Manufacturing & Controls (CMC) Proper Identity, Quality, Purity & Strength Expand graded CMC content (Phase 1 2 3) Safety information in amendments Scientific quality in annual reports Sponsor / FDA meetings, i.e. Pre-IND, End of Ph2, pre-bla
11 Application to a Typical Process for LBPs Inoculation Open handling (LAF) Precultures Fermentation Concentrate + wash cells (TFF) Disposable (sterile) systems Formulation Filling in vials/trays Freeze drying
12 GMP Manufacturing CMC Content Bulk Drug Substance & Drug Product Raw materials Manufacturing site facility(ies) Cell bank(s) Manufacturing process Quality Control QA GMP batch release Stability
13 Raw Materials Suppliers Qualified vendors, audits. GMP grade Source Animal free (evidence if unavoidable & permission) TSE / BSE statements Quality Control Suppliers release criteria Pharmacopiea & validated methods for internal testing Quality Assurance review & release Warehousing & GMP materials management
14 Manufacturing Site(s) Name, address, inspection history Compliance to Sponsor s Quality System Site Master File Floor plan People, materials & process flows. Segregation Clean room classifications & air handling Documentation management; Polices, Procedures, SOPs / BPRs Business activities Expertise, detrimental products or practises
15 Cell Banks Master (MCB) Working (WCB) Product Source, donor, history, health Characterisation Phenotype: biological activity, function Genotype: manipulations, antibiotic resistance, stability, impact Methods of GMP preparation, materials QC release testing & QA GMP release GMP storage, segregation, stability
16 Manufacturing Process Bulk drug substance (class C, D cleanrooms) Equipment; stainless steel, disposable, product contacting Media & component sterilisation, inc. validation Growth kinetics & harvest point criteria UF/DF parameters, cell density & viability Drug product (class A, B cleanrooms) Process holds, duration & temperature impact Dosage form (vials, bulk lyo), 100% visual inspection Validation expectations
17 Quality Control In-process control (IPC) & QC release testing Identity, total / viable counts, purity & absence objectionable organisms, biological activity, specific metabolites / substrates Quantitative results, not qualitative; Phase 1 3 Verification / qualification as minimum validation Batch-to-batch variability impact, Pharmacopeia methods? Specificity, recovery aspects of viability & contamination Quality Assurance review & approval
18 QA GMP Batch Release Not clinical release per IND / CTA (Qualified Person) QA review of release certificates, executed production records & QC data Quality System compliance; management procedures, instructions (inc. tracking & management) QP s liability to ensure cgmp compliance & product safety, not adulterated, no risk to humans Batch records, cgmp CoC, CoA
19 Stability Long term, accelerated, freeze/thaw, in-use Bulk drug & drug product. Phase Demonstrate stability profile prior to administration Stability indicating methods; ph, Appearance, Moisture Total / viable cell counts Biological activity / potency Bioburden / purity ICH guidelines
20 Additional GMP Elements Container closure suitability Labelling, packing & distribution procedures Process development characterisation validation Quality by design (QbD) Quality Risk Management (QRM) principles & Assessment (QRA) Identify Critical Quality Attributes (Specification e.g. viability) Define, measure & control Critical Process Parameters Lifecycle approach (starts in process development) Characterised reference material
21 The 10 year Path Live Biotherapeutic Products must meet pharmaceutical regulations cgmp for Medicinal Products Pharmaceutical Quality System Define & expand CMC content You may negotiate timelines & costs but never compromise on Quality!
22 Microorganism Experience Live Bacterial Products Bifidobacterium longum Bifidobacterium spp. Lactobacillus spp. Lactococcus lactis Oxalobacter formigenes Saccharomyces cerevisiae Salmonella typhi Vibrio cholerae Others (non-disclosed) Production Organisms Escherichia coli Pseudomonas fluorescens Haemophilus influenzae type B Corynebacterium diphtheriae Neisseria meningitidis (group A, C) Bordetella pertussis Pichia pastoris Saccharomyces cerevisiae Cultured under microaerophilic conditions Cultured under aerobic conditions
23 Your partner of choice cgmp Live Microbial Products Come talk to us at booth #6 Trust us to make it right!
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