Catalent Biologics & Clinical Supplies The SMART Solution

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1 Catalent Biologics & Clinical Supplies The SMART Solution Advanced Technology and Integrated Solutions From DNA to Clinical Supply & Cold Chain Distribution Dr. Florian Schwaak Account Manager Germany & Eastern Europe

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3 Catalent Can Improve the Value of Your Biologics Treatments at Every Stage Pre-Clinical Phase I Phase II Phase III Cell Line Engineering GPEX Technology ADC Development SMARTag Technology Oral Macromolecule Delivery (ZydisBio, Optigel Bio) Bio Manufacturing* Analytical and Lab Services Fill/Finish Manufacturing** and Supply (Parenterals, ADVASEPT Technology, Inhalation) Biosimilars Development Clinical Supply Solutions Regulatory Support *Currently offer Biomanufacturing up to 1000L **Pre-filled-syringe, Blow-Fill-Seal, and ADVASEPT Technology are offered through commercial scale 2

4 Catalent s Full Portfolio of Biologics Solutions GPEx Technology Fast development of higher expressing, more stable cell lines SMARTag ADC Technology Site-specific and programmable conjugation technology enhancing potency, safety, stability of Antibody-Drug Conjugates Process Development & Expanded Clinical Biomanufacturing Utilizing single-use systems up to 1000L Biosimilar Development Programs Portfolio of programs for development and licensing

5 Get to Clinic Faster with GPEx Cell Line Solutions SPEED TO CELL LINE DEVELOPMENT Faster than standard expression technologies HIGH EXPRESSION LEVELS Genes inserted in active regions with single inserts at multiple sites 100% cell pools stable and expressing target protein PROVEN TECHNOLOGY 100+ customers Over 500 mabs & proteins 5 commercial products >30 ongoing clinical trials INTEGRATION FROM START TO FINISH FASTER PATH FROM GENE TO CLINIC PROVEN CELL LINE DEVELOPMENT SOLUTIONS Why GPEx is Faster to Clinic No antibiotic selection No gene amplification No stability selection 2/23/2015 CATALENT CONFIDENTIAL 4

6 Why is GPEx Technology Unique and Differentiated? Versatile Works on any mammalian cell line, and many eukaryotic cell lines High Yields Gene inserts target active regions of the cell genome, allowing for high levels of antibody production from the cell pools and lines Shortened Timelines Antibiotic selection or traditional gene amplification is not required, resulting in shorter clonal cell line development timelines Complex Molecules High transduction efficiency, coupled with no antibiotic selection requirement, allows easy titration of multiple genes to the correct gene ratio to yield maximum recombinant protein production and efficient protein formation Time & Cost Savings The technology inserts each copy of the transgene at a different genomic location producing very stable gene insertions and stable expression from both pooled and clonal selected cell lines. 5

7 SMARTag TM ADC Conjugation Technology

8 SMARTag Technology: Better Proteins Advanced Technology for the Development of Optimized Antibody Drug Conjugates: Site specific programmable drug placement Novel aldehyde tagging technology Control of drug location to maximize ADC performance Improved consistency of ADC product Better regulatory compliance Proprietary toxin/linker technologies Improved stability and payload release Range of toxin/linkers to optimize efficacy by target Efficient and scalable process One step in vivo tag generation Compatible with any cell-based expression system Simplified analytics SPECIFIC MODIFIABLE ALDEHYDE RECOMBINANT TAG 7

9 Process Development & cgmp Manufacturing

10 Catalent Biomanufacturing Fact Sheet: Madison, WI Upstream/Downstream process & analytical development Over 100,000 sq ft site through phase IIb (PIII/commercial scale targeted for 2017) Manufacturing scale and flexibility cgmp 1000L, 500L, 250L (plus feeder vessels) Process Dev 250L x 2 (plus feeder vessels) GPEx and non-gpex capability Single use technology Small-scale and large-scale process development labs Integrated analytical services, viral clearance, fill/finish, and clinical supply Experience in aldehyde tagged antibody production (SMARTag Technology) 9

11 Analytical Capabilities from Candidate Selection to Manufacturing Biostructural Characterization N-terminal sequencing Amino Acid Analysis (AAA) Peptide mapping Extinction coefficient determination Carbohydrate analysis Circular dichroism (thermal stability) High-order structure Biosafety Analysis Validated infectivity and qpcr assays for virus detection State-of-the-art PCR suite BSL-3 suite Virus clearance evaluation (validation) studies in support of Early (Phase I) & Late (Phase III) Stage Development Microbiology USP/PhEur Method Development & Validation Services Environmental Monitoring 10

12 Biosimilar Development

13 Leader in Biosimilar Cell Line Development Catalent GPEx Technology Yield high-expressing, extremely stable, mammalian cell lines Speed to Clinic (4 years in average from licensing to market) Portfolio of Cell Lines for Biosimilar Development 10 cell lines available for licensing New cell lines being developed each year Therapeutic Areas: Oncology, Asthma, Autoimmune/RA, Osteoporosis, RSV, Cystic Fibrosis, Multiple Sclerosis Full Range of Customers Small Biotech companies with technical expertise Generic/small molecules companies Companies sourcing existing cell lines or needing custom development Flexible Work Plan Non-exclusive cell line agreements Specific terms for multiple cell lines deals Process Development & Analytical support PI GMP manufacturing (and beyond)

14 Clinical Supplies Services & Cold Chain Distribution

15 Innovation and Automation for Complex Challenges Our packaging experts provide you superior quality, unlimited capacity, and unmatched speed for your packaging needs. Innovative solutions with automation: high speed blistering, sealing, labeling automated scan and assembly syringe labeler and Plunger Rod Insertion globally highly experienced in frozen to refrigerated IMP handling global clinical labeling system Special handling suites: Cytotoxic/potent compounds, hormones Controlled substance (Class I-V) Frozen, refrigerated and humidity controlled Best-in-class primary and secondary packaging available: Blisters and bottles, API in capsules or bottles Feasibility and pivotal stability packaging Thermoforming and cold-forming capabilities 14

16 Expert Logistics and Systems for Tailored Solutions with Confidence We will store your material and take your clinical trial where and when you need it Save cost using our GMP compliant, state-of-the-art facilities in the US, UK, Germany, China, and Singapore Gain global reach and eliminate complex import/export handling with our extensive depot network Provides you peace of mind with customer focused global logistics Customized Shipping Protocols Automated Notification Pack Slip pdf file Hotlink to tracking information Customer Web Portal QP services provided Cold, frozen or ambient storage Controlled drugs JD Edwards for all sites on global server Returns storage and reconciliation IVRS/IWRS 15

17 Supply Your Trial Where and When You Need It 16

18 Why Catalent? - Reduce timeline and gain peace of mind Leading supplier with 25+ years industry experiences handling 4,500+ trials in 80+ countries Proven project management and supply chain solutions Automation and innovative solutions Global sourcing and distribution network Strong quality system and compliance 99% On-time delivery record Integrated services from Development to Packaging Clinical Supply Management Comparator Sourcing Blinding & Manufacturing Analytical Services Labeling & Packaging Storage & Distribution Catalent Clinical Supply 17

19 Many Thanks