Recent Opportunities & Challenges in microbial manufacturing

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1 Recent Opportunities & Challenges in microbial manufacturing Elise Mous, CPhI Frankfurt, Oct

2 Industry trend & challenge Customer perspective on outsourcing Key trend: Overall outsourcing growth remains Increased diversity in pipelines; volumes are more scattered Pharmaceuticals; small molecule intermediates and API s Biopharmaceuticals; recombinant proteins, mab s, insulin products, vaccines, cultured cells/tissues, blood products, biogenerics Increased overall volumes; growth of developing countries, aging population Continued make-or-buy decisions; tendency to keep commercial products in-house Key challenge: Outsourcing decisions become increasingly complex Strategic drivers; short-term fix versus long-term partnership Finding the right information & solution (scattered landscape) Increased complexity in decision making Timing, planning (when to decide & involve?) Technology (in-house vs. partner, stainless steels vs. single-use, expression system) Quality, reliability Capacity (development, scale-up, commercial) Source: internal analysis; Capua BioServices customer survey 2016; 14 th annual report and survey of biopharmaceutical manufacturing capacity and production, Bioplan associates,

3 Capua BioServices at a glance Our experience is your solution High-quality services; microbial process development and manufacturing Serving a global market; about 190 employees, head quartered in Capua, Italy Broad technology base; more than 50 years of experience with various bacterial, yeast and fungal systems from lab (2 L) - to pilot (3 m3) - to industrial scale ( m3) Extensive track record; in delivering proteins, (high value) small molecules and microorganisms for applications in pharmaceutical, food/feed and other bio-industrial markets Reliable and cost-efficient; without compromising on quality and safety Flexible and transparent customer service -2-

4 Site history Over 50 years of fermentation experience GIST BROCADES Acquisition of the site CMO FOCUS Start of CMO activities for pharmaceutical and food industry PATHEON Merger of DSM Pharmaceutical Products and Patheon PIERREL Start of pharmaceutical activities within Pierrel ROYAL DSM Acquisition of the site DSM BIOSOLUTIONS CMO activities branded within Royal DSM CAPUA BIOSERVICES Privately owned CMO (LIVIA Group) -3-

5 Workforce Our people make the difference Other 13% High School Diploma 52% Managem ent 2% Supply Chain 6% Sales, FICO, HR 6% Science/ Engineers 23% More than 20 years 33% 0-5 years 18% University Degree 35% QA 4% QC 12% Productio n 47% years 36% 6-10 years 13% By education By function By length of employment -4-

6 Capua site capabilities Focus on small molecules, (recombinant) proteins, microorganisms FERMENTATION 28 vessels 2 plants 3 to 35 to 50 to 100 m m3 total capacity PURIFICATION Chromatography Crystallization, UF, MF Evaporation, Drying Separate plants for pharma/food DEVELOPMENT Fermentation (2L, 15L, 3 m 3 ) Downstream (lab, pilot) Spray drying PRIMARY RECOVERY Centrifugation, Filtration Cell rupture, Drying Separate plants for pharma/food FINAL PROCESSING, FORMULATION Solid and Liquid formulation Filling and Packaging Spray Drying (Up to API-grade) Warehouse & Global logistic services -5-

7 Recent expansion Spray-drying facility Capabilities: Piloting equipment; evaporation capacity of about 3-5 kg of water per hour Commercial equipment; evaporation capacity of about 100kg of water per hour Services: Part of a project or stand-alone service Excipient and solvent screening Process parameter optimization Scale-up and GMP spray-drying Stability testing QA release -6-

8 Quality Focused on delivering quality & reliable solutions Quality System, based on Quality Standards: ICH Q7 FDA & EU guidelines for API and Food FSSC (ISO 22000, ISO/TS ) Codex alimentarius & FCC HACCP (Dir. CEE 852/2004) Law International Guidelines Site General Procedures Department Procedures Quality Certifications FDA approved since 1970 AIFA; GMP certificate for API Certificate of suitability for API (EDQM) CSQA; FSSC certified since 2016 Italian Ministry of Health (MoH; veterinary division) Kosher (OU) & Halal (HFFIA) -7-

9 Regulatory & Inspection Audit track record Date Regulatory authority Inspection Outcome 2017 (Jun) FDA cgmp compliance One non critical observation 2016 (Oct) AIFA phase II and III clinical trials products approval review of general cgmp compliance of the facility One major observation 2015 (Jan) FDA cgmp compliance No 483 form 2014 (Dec) Ministry of Health Veterinary branch cgmp compliance No major observation 2013 (Sep) AIFA phase III clinical trials product approval commercial phase product approval review of general cgmp compliance of the facility One major observation 2012 (Jul) FDA cgmp compliance No 483 form 2009 (Oct) FDA cgmp compliance No 483 form -8-

10 Project Management Your project in our capable hands TECHNOLOGY TRANSFER LAB & PILOT SCALE SCALE-UP ENGINEERING CONSISTENCY VALIDATION COMMERCIAL PRODUCTION Interdisciplinary project teams; experienced in international business & managing multiple projects in parallel Easy & direct access; link the experts within project network, orchestrated by dedicated project manager and account manager Project plan is part of the contract; milestone and deliverable based, managed by stage-gate approach; Joint reviews at each stage on how best to proceed Custom & transparent communication structure; form and frequency to fit to customer and project needs. -9-

11 Case-study: enzyme manufacturing Fast track implementation, scale-up & commercialization Challenge: Opportunity: Solution: Existing product Need for 2 nd supply Challenge on COGS Limited time-to-market In case of meeting COGS target than opportunity for significant volume growth commitment Fast-track technology transfer, scale-up, process qualification, commercialization Joint development program with client; build partnership & longterm relation Dedicated onboarding program designed (alignment on risk and responsibilities) Early & direct involvement of technology department, manufacturing & supply chain Joint, continuous improvement program & targets (win-win) Transparent & frequent communication with client Within 1 year, capacity improved >factor 2, COGS optimized by > factor 2-10-

12 Case-study: enzyme development Fast track project scoping & start Challenge: Opportunity: Solution: New product Need for development & manufacturing partner No clear decision on expression system & development needed Clear vision on end-game for commercial manufacture Fast-track project start with clear development component Joint development program with client Build trust and long-term, strategic relation Dedicated scoping program Preparation & alignment on foreseen scope-changes (management of expectations) Transparent & frequent communication with client Within 3 months, supplier selected, contract signed, collaboration started, process development activities ongoing -11-

13 Case-study: small molecule manufacturing Operational excellence Challenge: Opportunity: Solution: Existing product Running almost at full capacity No room for capex Short term need for extra capacity (peak demand) Help client to manage crisis & solve issue Increase trust and maintain long-term relation Implementation of continuous improvement program Matrix approach; direct involvement of technology department, manufacturing, supply chain & QA/QC Joint, continuous improvement program & targets (win-win, manage future expectations) Transparent & frequent communication with client Within 6 months, yield improved by 7%, product quality improved as bonus -12-

14 With every opportunity comes a challenge Success factors: Challenge: Flexibility, tailored solutions Style & frequency of communication Relationship, trust Joint objectives Cost improvement Focus versus change management Language, culture, tools Effort, control Different priority settings Win-Win -13-

15 With every opportunity comes a challenge Join us for cake, aperitivi & antipasti 4.1A (Tue/Wed) -14-

16 OUR EXPERIENCE IS YOUR SOLUTION