GE Healthcare s cell culture media, sera and process liquids

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1 GE Healthcare s cell culture media, sera and process liquids upstream downstream single-use Global operational footprint Imagination at work. services

2 GE Healthcare BioProcess technology and services GE Healthcare Life Sciences BioProcess business is one of the leading suppliers of solutions for the biopharmaceutical industry. We are proud to be able to include the recently acquired capability of HyClone cell products and services for our customers. Our robust portfolio of start-to-finish products, technologies, and services help clients solve their toughest bioprocessing challenges. HyClone cell culture products For more than 45 years, product excellence, customercentricity, and innovation have defined GE Healthcare HyClone products. That legacy, complemented by the global reach of GE Healthcare s BioProcess business today, provides enhanced business solutions that meet the needs of biopharmaceutical customers globally. It starts at the start: tier board meetings Quick HyClone facts More than 20 years of experience in cell culture media More than 45 years as a manufacturer of cell culture products Premium performance doesn t just happen it takes an unwavering dedication by an entire organization to deliver the best. This emphasis is exemplified by the tier board meetings. Tier board meetings are a series of 15 minute stand-up meetings designed to communicate issues from the production line to senior leadership teams. At the start of every shift, all technicians meet to review issues with quality, safety, and delivery schedules in what is known as tier 1 meetings. Technicians solve problems within their area of influence and expertise. Ideas or problems that exceed the capabilities of the technicians are communicated to supervisors and team leaders in tier 2 meetings. Tier 2 meetings are held within one hour of the start of a shift and are expanded to include quality assurance, engineering, human resources, and customer service. Every morning at 9:15 am MST, two tier 3 meetings take place simultaneously with the commercial operations and manufacturing operations teams to review the output from the global tier 1 and tier 2 meetings held previously in the day. These teams discuss line interruptions, process improvement ideas, capacity planning, order shortages, production misses, and many other manufacturing and commercial issues. The output of the commercial operations and manufacturing operations tier board meetings are reported in tier 4 meetings. Tier 4 meetings take place immediately following the tier 3 meeting and include directors, managers, and operations support. In these meetings, the leadership teams are briefed on any issues that were escalated from tier 1, tier 2, and tier 3 meetings. These successive tier board meetings take place every day, with the tier 4 meeting taking place at 9:45 am MST to brief the entire business on the previous day s activities and prepare for the day ahead. 2 3

3 Logan, Utah, USA Center of excellence With more than 400 employees and global centers for R&D, operations, manufacturing, logistics, technical support, customer service and marketing, our Logan campus serves as the cell culture center of excellence. Liquid media and process liquids cgmp and ISO standards guide the manufacturing of our liquid media and process liquids. These standards enable stringent controls regarding raw material control and segregation of manufacturing processes. The Logan campus also has: L single-use manufacturing capacity Small-volume liquid media (SVLM) manufactured in class 1000 (ISO 6) clean room Large-volume liquid media (LVLM) manufactured in class (ISO 7) clean room cgmp, ISO 9001:2000, and ISO 13485:2003 compliance Powdered media Our manufacturing facilities are designed to meet stringent regulatory requirements, robust capacity demands, and rapid speed of service. We offer two production methods for powdered media manufacturing: Traditional ceramic ball milling with up to 4000 kg capacity per batch Dedicated animal origin-free pin milling facility capable of delivering lot sizes up to 6500 kg per batch. Logan capabilities Liquid media and process liquids Powder media Rapid Response Production Serum processing Serum Serum is manufactured in two 3000 L stainless steel tanks with strict process controls to minimize lot-to-lot variability, enable ultra-low hemoglobin and endotoxin levels, and provide reduction in mycoplasma. Our industry-adopted standards for serum processing include: True pool processing Triple 100 nanometer filtration Closed system cardiac puncture collection Product delivered in single-use technology Originally intended to fill an internal operational need for the storage and transportation of media and process liquids, we now provide our customers their product in a wide range of single-use containers. These chambers have wide-ranging use from storage and transport to sensitive cell culture and bioprocessing applications. All single-use products are Annex 1 facility Completed in 2011, the expanded largevolume liquid manufacturing facility is compliant with Eudralex Volume 4 Annex 1 requirements, enabling unilateral flow of materials throughout the production process. The Annex 1 facility has complete segregation manufactured and packaged to meet the industry s high quality standards: Manufacturing takes place in ISO Class 7 clean rooms Packaged in two independent dust barriers Gamma-irradiated in outer packaging using kgy Large-volume liquid manufacturing facility of component preparation, product formulation, and filling to minimize contamination risks. Additionally, separate air handling units for each manufacturing area allows HEPA-filtered air to be dedicated and isolated to each separate manufacturing process step. 4 5

4 Singapore The Singapore facility for powder media was opened in 2013 as a secondary manufacturing location to Logan. The facility is located in close proximity to the Tuas Biomedical Park (TBP), which is home to many multi-national biopharma companies including Pfizer, GlaxoSmithKline, Novartis, Roche, and Lonza. The GE Healthcare powder media facility is a square foot cgmp and ISO certified manufacturing plant, mirroring the functionality and quality systems used in the United States. The new facility increases capacity for the production of our HyClone and HyCell powder media products, establishing a reliable supply chain for biopharmaceutical customers and an additional global logistics hub for distribution within Asia Pacific. The facility and equipment used are in compliance with 21 CFR 820 cgmp, ISO 9001:2000, and ISO 13485:200 guidelines. Quick facts Pin mill technology with three blender processes Continuous flow process with batch sizes ranging from 10 kg to 5200 kg Strict temperature-, pressure-, and humiditycontrolled environment Mirrors quality and functionality of US powder media manufacturing Singapore capabilities Powder media Listening to our customers When our customers speak, we listen. At GE Healthcare, we listened when our customers asked for reduction in lot-to-lot variability in serum. We changed our serum manufacturing processes to incorporate true pool processing, which enables lot-to-lot consistency for every bottle of GE Healthcare HyClone serum shipped from our facilities. We listened when our customers asked us for more effective methods to ship media, buffers, and process liquids. So we offer single-use containers, with a high-quality film formulation that minimizes leachables and extractables. 6 As regulatory standards matured toward animal-origin free products, we worked diligently with our customers to create high-performing animal origin-free products and processes like our serum-free HyCell CHO medium and fully segregated animal-origin free liquid media manufacturing facility. As our customers grow globally, we continue to increase capacity and broaden our footprint to meet their growing needs. 7

5 Australia and New Zealand Mordialloc, Australia Tauranga, New Zealand Serum processing centers in Australia and New Zealand provide consistent products in accordance with cgmp requirements. New Zealand and Australia are protected from many outside influences, both geographically and biologically. One of the benefits of this isolation is that Australia and New Zealand have the fewest reported cases of bovine diseases in the world, including BSE and FMD. Most of the New Zealand and Australian serum products are filtered through three sequential 100 nm (0.1 µm) pore-size filters. Australia quick facts Filtration batch size of 1000 L Clean room suite Freezers (-20ºC) Raw serum sourced from approved third-party fetal bovine serum (FBS) raw serum processing centers New Zealand quick facts More than 6000 square feet Filtration batch size of 2500 L Clean room suite Freezers (-20ºC) FBS collection Raw blood and serum sourced from approved third-party FBS raw serum processing centers Adult bovine and newborn calf serum purchasing plants Australia and New Zealand capabilities Serum processing 8 Smarter sourcing every step of the way Our sourcing teams work to create transparency and predictability throughout the entire supply chain. Multiple facility manufacturing redundancies, raw material and finished product stocking programs, and dual supplier sourcing strategies are all investments we make to enable supply of the product you want, when you need it. 9

6 Rapid Response Production The GE Healthcare Rapid Response Production process is a short-turnaround, non-cgmp media service designed to meet clients specific process and culture needs. Samples of media are typically manufactured within seven days, with multiple rounds of prototyping and analysis conducted utilizing our rigorous Metabolic Pathway Design approach. Manufacturing takes place in a noncgmp production suite capable of preparing up to 200 L liquid lot sizes and up to 20 kg dry powdered lot sizes. Liquid lots are packaged in 100, 500 and 1000 ml bottles or bioprocess containers. Dry powdered lots are packaged in volume-specific bottles or in bulk containers. 10

7 We know quality Many companies test for quality. At GE Healthcare, quality is simply engrained into who we are. Throughout the design and manufacturing process, every aspect of your GE Healthcare cell culture products meet stringent quality requirements and achieve a high level of performance. We take a three-tiered approach to quality control for GE Healthcare cell culture products: quality by design (QbD), process control, and key attribute performance testing. QbD at GE Healthcare means evaluating suppliers, performing design failure mode effect analysis (DFMEA) and process failure mode effect analysis (PFMEA), conducting design of experiments, and building quality into the facility design much like the Annex 1 liquid media manufacturing facility. Process control enables consistent processes that continue to improve. We rely on statistical process control (SPC), process qualification and validation, and continuous improvement. Finally, key attribute testing allows us to test products for quality at every stage of the manufacturing process, even well before the process starts with raw materials testing, in-process testing, and finished goods testing. 12

8 GE Healthcare HyClone cell culture Global manufacturing and logistics Singapore Media Logan, UT, USA Media, process liquids, sera, logistics Tauranga, New Zealand Sera Mordialloc, Australia Sera 14 15

9 GE Healthcare UK Ltd. Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK GE Healthcare Europe GmbH, Munzinger Strasse 5, D Freiburg, Germany GE Healthcare Bio-Sciences Corp. 800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ , USA GE Healthcare Japan Corporation Sanken Bldg , Hyakunincho, Shinjuku-ku, Tokyo , Japan For local office contact information, visit GE Healthcare Bio-Sciences AB Björkgatan Uppsala Sweden GE, imagination at work, and GE monogram are trademarks of General Electric Company. BioProcess, HyClone, and HyCell are trademarks of General Electric Company or one of its subsidiaries General Electric Company - All rights reserved. First published Mar All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information AA 03/2014