BIOPHARMACEUTICAL PROCESSES
62Pages

BIOPHARMACEUTICAL PROCESSES

WE INSPIRE CONFIDENCE AT EVERY POINT OF CONNECTION CPC (Colder Products Company) is the leader in the design and manufacture of single-use connection technology and connectors for the biopharmaceutical market. CPC offers a wide variety of solutions including sterile connect, sterile disconnect, SIP connections and open connects. Our innovative designs provide flexibility for biopharmaceutical manufacturers to easily combine multiple components, single-use or hybrid systems including process containers, tubing manifolds, transfer lines, bioreactors, and other bioprocessing equipment. Easy to...

EXPERIENCE CPC is the leading provider of quick connect couplings, fittings, disconnects and combination connectors used in fluid transfer. We innovate, engineer and manufacture fit-for-purpose products in close collaboration with our customers. Founded in Minnesota in 1978, CPC has built a successful, growing company by focusing exclusively on critical points of connection within fluid management systems. CPC’s reach is global with operations in the US, Germany and China, sales offices in ten countries and hundreds of distributor partners and OEM solution providers around the world. CPC’s...

ONLINE RESOURCES Visit cpcworldwide.com/bio for answers to your questions about our company and products. VALIDATION TEST REPORTS Validation test reports provide details of all the testing that has been performed on the product to ensure confidence at every point of connection. Extractables data can also be requested. PRODUCT VIDEOS Check out some of the latest innovations, technologies, and product tutorials in our CPC biopharma videos. Our video library contains instructions on how to assemble CPC connectors as well as best practices and tips to ensure you get the most out of every...

REGULATORY AND COMPLIANCE ISO 13485 CERTIFICATION ISO 13485 is recognized by regulators around the world as a good basis for addressing medical device design and manufacturing regulatory requirements. It allows us to enhance product safety by proactively identifying and managing product and project risks. Our quality management system is ISO 13485 certified, which allows us to better control the consistency of manufactured products. ISO 9001 CERTIFICATION ISO 9001 is a standard which assures consistency of a product ordered by customers. Organizations having ISO 9001 certification have...

UNDERSTANDING SINGLE-USE SYSTEMS Increasing global demand for new biologics, vaccines and cell therapies is driving manufacturers to replace traditional stainless equipment with single-use systems, which consist of plastic-based processing equipment used in the development and production of biopharmaceutical drugs. BENEFITS OF SINGLE-USE Operational Efficiencies Increases flexibility and faster batch turnaround. Cost Effectiveness Minimizes cleaning and validation requirements. Economic Advantages Reduces capital expenditures and facility footprints. Improves sterility assurance while...

UNDERSTANDING THE BIOPHARMACEUTICAL MANUFACTURING PROCESS Media Preparation Seed train Production UPSTREAM Storage Solution Buffer Addition Steam Line Bulk Fill Bulk Formulation Final Fill & Finish Capture Chromatography Purification Chromatography Main process flow line Connectors: AseptiQuik Series, HFC Disconnect Series, Steam-Thru Series ® Media Addition Connectors: Open format, such as MPC Series, MPX Series, MPU Series Harsh Chemical Applications Connectors: AQG PPSU Series

Single-use bioprocessing is designed to be flexible, efficient, and effective in the manufacture of drug substances, monoclonal antibodies, vaccines, biosimilars and regenerative medicines. The process is split into two main sections, upstream and downstream. Along with growing the cell line, the purpose of the upstream process is to scale-up the volume of the target protein or cell from volumes as small as a vial to bioreactors that can be as large as 5,000L. Once the target specimen has reached a target yield, it turns the corner towards the downstream process. The goal of the downstream...

ASEPTIC CONNECTION TECHNOLOGY* PAGES 10-23 12 MICROCNX® SERIES CONNECTORS: Sterile connection for your 1/8” flow applications MATERIAL: Polycarbonate, silicone TERMINATIONS: 1/16"; 3/32" & 1/8" ID hose barb (1.6mm, 2.4mm and 3.2mm) 16 ASEPTIQUIK® S SERIES CONNECTORS: Sterile connection for your 1/4” flow applications MATERIAL: Polycarbonate, silicone TERMINATIONS: 1/8"; 1/4"; 3/8" ID hose barb (3.2mm, 6.4mm and 9.5mm); 1/4"; 3/4" sanitary & MPC insert 18 ASEPTIQUIK® G SERIES CONNECTORS: Sterile connection for your 1/2" flow applications MATERIAL: Polyphenylsulfone, polycarbonate and...

OPEN FORMAT CONNECTION TECHNOLOGY PAGES 36-49 40 MPC SERIES CONNECTORS: Open-format connection for your 3/8" flow applications MATERIAL: Polycarbonate, polysulfone and silicone TERMINATIONS: 1/8"; 1/4" & 3/8" ID hose barb (3.2mm, 6.4mm, 9.5mm) 42 MPX SERIES CONNECTORS: Open-format connection for your 1/2" flow applications MATERIAL: Polycarbonate, polysulfone, and silicone TERMINATIONS: 3/8"; 1/2" ID hose barb (9.5mm & 12.7mm) MPC/MPX BACK-TO-BACK SERIES ADAPTERS: Connect single-use systems that may feature identical connections at the end of their tubing. MATERIAL: Polycarbonate,...

ASEPTIC CONNECTION TECHNOLOGY

MICROCNX® SERIES CONNECTORS MicroCNX® Connectors introduce a new category of aseptic micro-connectors that provide a simple, efficient method of connecting tubing for small-format biomanufacturing assemblies. MicroCNX connectors are the modern alternative to the cumbersome, industrial process of tube welding. Building on the inventiveness of CPC, the leader in single-use connection technology, the MicroCNX line of connectors is engineered specifically for the challenging conditions of biologic media transfer in bioprocessing, cell therapy and gene therapy applications. OPERATING PRESSURE Up...