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Biopharma
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Downstream
Polishing

Polishing in Downstream Processing

A biopolishing finish prepares the biologic product for the final product packaging. During this biopolish process, any trace contaminants and impurities of the target product are removed from the feedstock. Crystallization, desiccation, lyophilization and spray drying are common polishing in downstream.

Obtaining a High-Yield Biopolish

By this time in the downstream process, the feedstock has high concentration of the target molecule with some select impurities or aggregates. Polishing chromatography is used to obtain higher purity by removing the remaining most-difficult, minute amounts of impurities and remaining traces of DNA, endotoxins and host cell proteins. For the polishing step, highly efficient filters for smaller particle sizes of 35 µm and smaller are typically used.

Put the Finishing Touches on Biopolishing Workflow Processes with CPC

Designing robust polishing operations in downstream processing are vital to overcome potential issues of scale-up, flexibility and installation in the production of biologic products. The expertise and experience CPC has gained over more than 40 years has resulted in aseptic connection technology that meets the increasing complexity of process fluids produced by today’s bioprocessing and cell and gene therapies. Collaborating with manufacturing and process design engineers around the world, CPC has helped to design and implement biopolishing finish workflows that provide a cost-efficient final separation process that produces a high yield with enhanced impurity removal.

Single-Use CPC AseptiQuik^® Sterile Connectors

Supports any tubing length—no minimums required
Connects to any type of tubing, including silicone, and different types of tubing
Connects different hose barb sizes
Connectors from the same family can be interconnected
Maintains flow path sterility and integrity
No extra space, materials or equipment required for connector use
Customer accessible extractable profile per BPOG guidelines
Maintains a sterile boundary between two adjoining single-use systems

Aseptic-SingleUse-Connectors-Range

Meeting Extractables and Leachables BPOG Guidelines

Rising adoption of single-use technology (SUT) in downstream processing, including polishing, has led to concern of potential extractables and leachables (E&L) contamination and regulatory scrutiny about E&L testing. The FDA requires E&L data in biological license applications for quality assurance. CPC AseptiQuik^® Sterile Connectors were tested for extractables per the BioPhorum Operations Group (BPOG) guidelines and given an acceptable extractables profile. The profile and testing information needed to assess the materials of construction are available to manufacturers to help make sure polishing processes deliver a biologic product that’s stable and transportable.

Efficient Biopolishing with CPC Aseptic Connectors

The broad portfolio of innovative CPC aseptic connectors is engineered to provide the appropriate connection technologies to help advance biopolishing finish workflow processes. CPC aseptic connectors ensure efficient changeover and operator safety in managing polishing feedstock. The streamlined, genderless design simplifies polishing system integration, further reducing operator error and eliminating added costs due to installation time or delays due to connection issues.

Seven Benefits of Single-Use CPC Aseptic Connectors

Support for a wide variety of polishing technologies
Ensure closed connection and disconnection for media transfer
Suited for bag and bottle assemblies used in polishing
Streamlined design for ease of use
Repeatable performance with no additional hardware
3-step connection process reduced operator error
Sterile connection even in non-sterile environments

Versatility and Flexibility

Flexibility is a key requirement for biopolishing finish workflows. CPC aseptic connectors provide flexibility to easily combine multiple components including process containers, tubing manifolds, single-use and metal transfer lines, bioreactors and other bioprocess equipment. When changeovers need to occur, genderless CPC aseptic connectors make it easy to connect and disconnect components and processes. Multiple termination options meet today’s mounting and flow requirements.

Innovative Design

CPC’s comprehensive portfolio of aseptic connectors with multiple sizes, configurations, termination options and materials for use with a wide variety of polishing techniques. Innovative connection methods help eliminate contamination risk and ensure connection assurance. CPC’s biopharma design and application engineers develop innovative, high-quality products that make sterile media transfer during the biopolish process safe and easy.

Trusted Reliability

CPC sterile connectors are engineered for upstream and downstream processing including polishing. By helping maintain aseptic transfer of media and impurities removal, CPC sterile connectors facilitate getting the best biologic product yields at a cost-effective price. All CPC aseptic connection solutions are rigorously tested ─ including materials testing, product testing and torture testing to failure ─ to meet product specifications. As a matter of fact, CPC offers reliable, reproducible performance and provides validation and extractable reports that support the performance attributes.

Overall Robustness

CPC aseptic connectors deliver optimized flowrates with excellent flow to size ratio for superior performance to manage the media and impurities fluid transfer required during polishing. CPC purpose-built connectors are designed to be compatible with the wide variety of polishing platforms and processes. We provide a unique combination of industry expertise with the broadest portfolio of products including sterile connects, sterile disconnects, SIP connections and quick connects.

Sterility Assurance

Increased cell densities and complex polishing fluids mean manufacturers must design their facilities to manage shorter production runs with multiple changeovers. Single-use bags and transfer lines use CPC MPC or MPX Connections and SaniQuik^™ Adaptors for quick changeovers. Robust and easy-to-use, single-use, aseptic connectors from CPC maintain flow path sterility and integrity while enabling biopharmaceutical manufacturers to use the appropriate biopolishing processes and platforms to improve biologic product yields and reduce costs.

Security of Supply

CPC has a proven track record of providing products consistently under their stated specifications and quality requirements through having a strong supply assurance program. The program includes control of the manufacturing process from raw materials to final product manufacturing. Investments in extra capacity and redundant manufacturing ensure capacity when it’s needed. Biopharma customers have confidence in CPC’s ability to fulfill demand acquired by a track record of accurate lead times, identifying and communicating potential delays and, most importantly, by sound supply chain management.

Sterile Connectors

Easy-to-use AseptiQuik® and MicroCNX® Connectors provide quick and sterile connections, even in non-sterile environments—a critical capability for your biopharmaceutical manufacturing.