. : Introduction: We are testing end-user responses to a potential new chromatography platform for a leading bioprocessing supplier. This new product line provides the major functionalities and features of current chromatography systems and resins, while incorporating updated features of high-end equipment, e.g.,: Fully scalable, plug-and-play, easy-to-use hardware and software, modularity (columns/components), modern data transfer and networking, broader range of operating conditions End-user serviceable New features, e.g., true multi-column & continuous chromatography Comprehensive ranges of affinity and polishing consumables and resins Cost of product line comparable to other similar devices The new product line is described in the following slides. Please review these. In your interview we ask your reactions and views. New Biopharmaceutical Chromatography Platform: Review of Attributes
2 Proprietary & Confidential Scalability Fully-scalable range from lab-scale/analytical models through bench, pilot/clinical scale protein purification, and commercial scale platforms similar to GE AKTA Pilot/Comm’l = 100–1000+L (e.g., Ø cm, & cm Comm’l); Benchtop = 3–100L (~5 to 25cm) Meets cGMP requirements; PAT, QbD and DOE with related software options built-in Interchangeability: Vendor supplies resins / consumables but also works with resins and consumables from all major suppliers Developed and supported by a major supplier with decades of expertise in this segment Bench scale systems Includes or exceeds the functionalities of your current chromatography systems; Modularity / Plug & Play: Columns/components mix-and-match; user friendly software automatically updates based on configuration chosen Multiple / parallel operation, e.g., 6, fully independent columns with one controller options Robotics, including high-throughput and other screening options Pilot / Process Scale Systems Single-use flow path options Supports all current modes of chromatography, including continuous processing Software Same software can control systems from bench top to manufacturing, providing scale-up options Software can run analytical systems, e.g., HPLCs, GCs, mass spectrometers Improved data processing tools allow faster results analyses, more intelligence, and built in wizards Diverse modern networking and data transfer and processing capabilities Summary of Key Technology Platform Attributes
3 Proprietary & Confidential Specific Design Attributes Bench Top Scale Modularity: Plug-and-play – columns, controllers, components and parts Large flow range: Pumps provide accurate flow from 1 to 100 mL/min Multi-mode: Standard single batch, multi-column, continuous and other modes Serviceability: Easy access to commonly exchanged parts, end-user repairs, quicker service times by engineers Robotics: Easy-to-integrate options, including 96-well high-throughput screening Detection: Options include UV, FLD, RI, ECD, CAD MS pH/conductivity; smaller scales handle more sensors than larger scales (where fewer used) Columns: Range of pre-packed columns for R&D / PD use. Supports other column formats Pilot / Process Scale Real-time control and feedback: Adaptable controls, informative reporting, incl. DeltaV Better connectability: Improved sanitary connectors to skids and bioreactors; can connect directly to biorector perfusion units for continuous bioprocessing Single use: Options for single-use (i.e., single campaign use) flow paths and columns to aid with cleanability Automated column packing options: Large column housing offering Decreased hold up volumes: Reduces product loss Resins: Optimized resins for batch and continuous chromatography, can use all major resins Buffer blending / dilution: Automated blending / dilution for easy operation
4 Proprietary & Confidential Critical Platform Attributes: Scalability Scalable Platform: R&D to Commercial Hardware and software are up- and down-scalable from lab to pilot-scale, using similar chemistries and designs From analytical scale, to over 1000L pilot/commercial scale Single software package supports all scales and capabilities. Provides relevant compliance tools for each scale. Full range covers from 1 mL/min to 3000 L /hr Software can model current processes to larger & smaller scales Equipment covers broader operating ranges and scales – need to purchase fewer different size models to cover all scales Wide range of pre-packed columns, resins, and auto-packing options for large scale columns
5 Proprietary & Confidential Critical Platform Attributes: Data Handling Control and Data Systems Software consistent and scalable across all scales and models Intuitive instrument controls; also wizards and modifiable pre-canned methods Software can also control analytical chromatography systems from most major suppliers. Integrated PAT, QbD and DOE software options - Also supports Mass Spectrometers Diverse data processing and research options, particularly, at analytic scales Good data handling & transfer; exportable to DeltaV, plain text, MS software, Oracle, etc. Real-time control; modern programmable software; intuitive-drag/drop process design and interfaces; option for GE UNICORN-like programming Potential to import data from major suppliers, e.g., GE Unicorn and BioRad NGC data Larger-scale programming can be standardized, simplified, made fail-safe, locked-down Easy connectivity/enhanced networking – Internet, Ethernet, wireless, etc. PC, LIMS and end-user notebook networking/data transfer Remote systems monitoring and control options; including fail-safe limits at larger scales Regulatory-friendly: Full FDA (21 CFR 11) and other regulatory agency GMP compliance Easy transfer of methods from one system to another, both up and down scales Automatic execution of SOPs for easy execution of routine processes Streamlined flexible user interface allows quick learning and major productivity gains
6 Proprietary & Confidential Critical Attributes: Integrated Software Capabilities Bench Purification LC/MS Multi- Channel Purification High Throughput Screening UHPLC or LC/MS Pilot Scale Purification Manufacturing Scale Purification QA/QC Analytics Centralized Data Storage Monitor / control / process data from anywhere – including remote access R&D / Discovery Process Development Manufacturing IT Infrastructure Software package supports purification scales from uL to >1000 Liter; provides migration tools from one scale to another. Supports both purification and analytical techniques. Centralized data storage allows linkage of purification and analytical information. Purification Analytics
7 Proprietary & Confidential System 1: Standard Bench Top Instrument Detector options include integrated FLD, RI, Mass Spec - allows mass-directed fractionations Option to add HPLC analytics; purify and analyze with a single system Performance consistent with GE AKTA Avant or BioRad NGC System 2: Parallel / Multi-Column System Run 6 columns independently; each channel comes with own pH/conductivity and UV monitoring Provides parallel operation for increased output or multi-column operation for screening experiments Uses same bench space as a traditional purification instrument System 3: Dedicated Instrument for High Throughput Clone/Resin Screening Workflows Compatible with 96-well plates, and diverse vendors’ columns and tips Smaller footprint / simpler to operate than existing platforms Connect to HPLC or HPLC / MS systems for immediate analytics Critical Platform Attributes: 3 Bench Top Systems All instruments are scalable & support multiple column formats
8 Proprietary & Confidential System 4: Batch System for Pilot / Process Similar in performance to models from other vendors Scale up tools to allow transfer from PD systems Column hardware and auto packing options Buffer blending and auto-dilute Single-use flow path option System 5: Continuous System for Pilot / Process (as batch, and…) Continuous chromatography for both capture and polish Software tools to transfer batch processes to continuous processes Online monitoring to constantly assess product purity and quality Single-use flow path option Software Same software as used for bench top instruments; reduces learning/training and support costs Software connects purification process to analytical information, providing rapid feedback and process control mechanisms Full GxP compliance Connectivity to Delta V Critical Platform Attributes: 2 Pilot / Process Systems
9 Proprietary & Confidential Critical Platform Attributes: Resins and Chemistry Resins Systems developer also offers a full range of resins Can also use resins from all major suppliers—interchangeable Fully scalable resins- bench to commercial scale High capacity resins, with demonstrated industry track record Technology provides a suite of affinity and polishing products for bioproduction Can rapidly develop customized affinity ligands & resins for process scale
10 Proprietary & Confidential Critical Platform Attributes: Customer Service Improved Support Services Remote diagnostic capabilities for faster service response Responsive, expert on-site repairs and service Do-it-yourself options for maintenance and simple repairs Parts, if needed, are in stock; quick delivery Responsive technical support Online and cloud-based tutorials, user-forums, reference manuals, Regulatory documentation Onsite, and off-site training options