Process Liquids & Buffers Collaboration Thermo Scientific Cell - PowerPoint PPT Presentation

Process Liquids & Buffers Collaboration Thermo Scientific Cell Culture & BioProcessing Global Headquarters: 925 West 1800 South Logan, Utah 84321

Process Liquids and Buffers Overview Capabilities Collaboration Custom Solutions Performance Attributes Business Solutions 2

Capabilities Overview PRODUCTS Single-Use Media, Buffers, Sera Technologies and Process Liquids SERVICES Rapid Response Optimization & Supply Chain Ongoing Customer Production (RRP) Scale Up Services Partnership (SCP) Support Customized media and Hands-on application- Collaborate to analyze your Global Field Application bioprocess containers specific custom solutions to supply chain needs to Specialists (FAS) provide (BPCs) solutions enhance performance and determine the most efficient rapid on-site technical manufactured within 7 days ensure scale-up process and cost -effective supply support services for your success chain management program everyday needs that meets your needs Enabling customers to manufacture safe and efficacious drugs 3

Manufacturing Expertise Quality • Over 45 years of manufacturing cell culture products • Highest Standards  ISO9001 (2008) and ISO13485 (2003)  EudraLex Annex 1  Medical Device cGMP 21 CFR820 • Lot-to-lot consistency  Validated standard operating procedures for small and large scale manufacturing Capability • Dedicated cGMP facilities and specialized personnel • Customer and process specific customization • Global footprint Innovative state-of-the-art manufacturing 4

Global Manufacturing Beijing, China Cramlington, UK Logan, UT, USA Global Presence • Three global sites: Logan, UT, USA; Cramlington, U.K.; Beijing, China • Assurance of supply through redundant manufacturing capabilities • One company, One process – consistent performance with harmonization of best practices Global footprint, reliable supply 5

Manufacturing Capabilities Liquid Products • Liquid manufacturing – up to 10,000L per batch Dry Powder • Ball Mill – up to 4,000kg per batch • Pin Mill – up to 6,500kg per batch  Animal-derived component-free (ADCF) Water-for-injection (WFI) Quality Water • High quality process grade water • Logan, UT, USA and Cramlington, U.K.  >60,000L/Day average capacity  Meets current USP and EP Stainless Steel and Single-Use • Stainless steel – robust capacity • Single-use – single contact manufacturing alleviates regulatory concerns We are the specialist industrial supplier of large volume liquid 6

Process Liquids and Buffers Overview Capabilities Collaboration Custom Solutions Performance Attributes Business Solutions 7

Reasons for Collaborating Safety Economy Infrastructure • • • Concerns with Reduce inventory Limited resources, hydrating caustic items, space focus on drug materials like NaOH discovery and • Capacity and production • Nuisance liquids resource constraints • used infrequently, Improve efficiency • Lacking quality difficult to handle with larger volumes system for water • supply (WFI) Avoid large capital investments in early • Back-up in-house stages capability 8

Production Efficiencies Gained Improve Cycle Times • Eliminate cleaning steps • Reduce manufacturing steps • Increase production output Reallocate Resources Reduce Cost of Quality • Focus labor on critical processes • QC testing • Floor space • Documentation packages • WFI reserved for critical processes • Validation Reduce Waste • Start-stop of resources • Chemicals staged prior to use • Storage of liquid prior to use Streamline Your Process – we do the prep work, you focus on making product 9

Case Study: Mid-sized CMO • Over 19 unique buffer solutions needed for campaign based processes • Custom delivery packaging • Objective was to help customer meet deadlines by simplifying logistics and addressing global regulatory requirements Problems addressed • Customer specification requirements were communicated and agreed • Logistics were customized to different buffers  Delivery systems including 10L, 50L, 100L, and 200L BPC and container designs  WFI in 200L drums Result: Customer Cost Savings: $250,000 per campaign in first year 10

Case Study: Large Vaccine Manufacturer • 18 unique buffer solutions in large quantities • Customer had little/no existing infrastructure • Objective was to help customer reduce infrastructure and warehousing requirements Problems addressed • Batch sizes from 100L to 6,000L were provided • Orchestrated “Just in Time” delivery  Recycled Arca bins Result: Saved customer time and money on capital equipment, QC validation, and logistical headaches 11

Case Study: Full Scale Biotherapeutic Manufacturer • Bioreactor feed supplement delivered “just in time” • Customer was receiving non-sterile material and re-filtering the product, costing them large amounts of time and money • Objective was to provide customer ready-to-use solution, save them time and money, and free up floor space Problems addressed • Delivered Dextrose solution in 200L BPCs  10,000L lots were produced, cost savings of volume  Reduced QC testing, qualification • Freed up valuable floor space and mixing tanks during production process Result: Enabled customer to focus on their specialty; making products 12

Case Study: Cost Savings Analysis • Cost Analysis - Phosphate Buffer 0.04M • Objective was to evaluate the costs of making buffers and other process liquids in-house and collaborating with Thermo Fisher Scientific • Performed using proprietary modeling software Production In-house Using Thermo Fisher Batch size (L) 2,000 8,000 Batch cost $11,500 $29,680 Batches Needed 20 5 Total Cost $230,000 $148,400 # of QC releases 20 5 Prep time per lot 4 hours 1 hour Total production time 80 hours 20 hours Result: Cost Savings: $81,600 75% Fewer QC Tests 60 hours less production time 13

Process Liquids and Buffers Overview Capabilities Collaboration Custom Solutions Performance Attributes Business Solutions 14

Which solutions should you consider collaborating? Commonly outsourced liquids Titration Reactor Feed Cleaning and pH Adjustment Chelating Equilibration, Buffers Supplements Sanitizing Agents Binding, and Elution • • • • NaOH Glucose, up Sodium EDTA • • Sodium WFI • to 60% HCl • Carbonate Chloride NaOH • • Acetic Acid • NaOH • Phosphate HCl • • • HCl Tris Urea • • Citric Acid Tween Outsourcing Expertise • More than 10 years of contract experience • Delivering custom powder and liquid solutions 15

Rapid Response Production (RRP) Program Dry Powder Liquid • Quickly optimize liquid solutions • Develop protocols for hydration • Quickly validate your QC specifications and • Quickly validate your QC specifications and quality requirements quality requirements • Lot sizes up to 200L • Lot sizes up to 20kg • Packed in 100, 500 and 1000mL bottles or up • Volume specific or bulk packaging available to 200L BPCs • Shipped within 7 business days of order • Shipped within 7 business days of order Custom solutions readily transferable to cGMP production 16

Custom Delivery Systems Products matching Process • Each process is unique • BioProcess Containers (BPC) provide optimal flexibility through customization of:  Type  Size  Function Rapid Response Program • Receive non-sterile prototypes shipped within 7 days • Sterile BPCs shipped within 5 days • Prototypes readily transferable to cGMP production Quickly customize fit, form, and function to your process 17

Primary Product Contact Delivering your product secure and stable relies on its primary container and warrants particular attention BioProcess Containers (BPCs) • Designed specifically for biopharmaceutical applications • CX5-14 is a multi layer, coextruded film that has:  Animal-free formulation  Gas barrier properties that preserve stability  Low extractable profile  Maximizes toughness, stress and puncture resistance, and flexibility Leachable and Extractable Testing • Extensive testing has been performed on CX5-14 under a variety of conditions Confidence in your product contact 18

Product Compatibility Liquid compatibility testing in BPCs • Buffers, acids, bases, alcohols, salts, etc will have different impacts • Tests have been employed to determine compatibility of our film for a wide range of liquids • These studies are based on a matrix of:  Chemical composition  Temperature  Exposure time  Concentration 19

Flexible Packaging Options Shipping Options • Corrugated shippers: 100mL to 20L • Bottom drain drums: 50 to 200L • UN liquid rated drums: 20 to 1,000L • Palletized bins: 250 to 1,000L • Packaging designed and validated to meet ISTA-2A and ISTA-1E standards Secure containment for every demand 20