Biopharma’s Largest Aseptic Connector Now Available

Introducing the AseptiQuik W Series Connectors, the industry’s largest genderless aseptic connectors. The new 1-1/2 inch flow path solution can easily transfer hundreds of liters per minute to significantly reduce fluid transfer time across the bioprocess.

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Single-Use Technology for Gene Therapy

The gene therapy process targets diseases by replacing, inactivating or introducing genes into cells— either inside the body (in vivo) or outside of the body (ex vivo). This technique treats a disorder by replacing a faulty gene or adding a new gene into a patient's cells instead of using drugs or surgery. By altering the genetic material of a patient, gene therapies allow the patient to begin producing healthy cells on their own.

Gene Therapies: Hope for the Prevention of Diseases

Gene therapies are looking to change medicine from being a treatment-based to a prevention-based practice. With new and ever-evolving genetic engineering technologies, researchers are turning to gene therapies as answers for preventing and treating many genetic diseases that currently have only symptomatic treatment or no treatment standard. Gene therapies offer promise for treating and curing a wide range of diseases, such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS.   

The ultimate goal, and hope, is that every genetic disease has a gene therapy treatment. While still an experimental technique, recent gene therapy approvals from the FDA and EMA along with more than 1,000 different types of gene therapies in clinical trials, have seen a rapidly growing industry and patients potentially receiving long-awaited treatment.

Viral Vectors Deliver Genetic Materials to Cells

The production of viral vectors is an important component of a successful gene therapy process. A gene is inserted directly into cells by using a carrier, called a vector. The most common gene therapy vectors are viruses. Viral vectors identify certain cells and carry genetic material into the cells' genes. In fact, these viral vectors act as Trojan horses to deliver the genetic materials to cells.

Other Types of Vectors in Clinical Trials:

  • Stem cells – cells from which all other cells with specialized functions are generated, providing new cells for the body as it grows. For gene therapy, stem cells can be trained in a lab to become cells that can help fight disease. 
  • Liposomes – fatty particles that can carry the new, therapeutic genes to the target cells and pass the genes into the cells' DNA. Liposome-based vectors are designed to target specific cells actively and safely by targeting molecules. 
  • Bacterial vectors – carry a plasmid-based gene to a new host cell. The genetic material is delivered by the bacteria entering into the target cells. 
  • Plasmid vectors – vehicles used to drive modified DNA (recombinant) into a host cell where it reproduces in cells, creating a group of cells with the same DNA strand.  

Lean on CPC’s Cell and Gene Therapy (CGT) Expertise

By collaborating with gene therapy manufacturers and partnering with equipment suppliers, CPC helps provide these evolutionary gene therapies in a faster time frame. CPC’s single-use technology for gene therapy helps in making sure efficacious, repeatable and standardized processes are maintained.

CGT manufacturers often struggle with the high costs of production including labor, supply chain and low yields. That’s where CPC comes in. Not only providing single use connection technologies for gene therapy, CPC also provides guidance in critical areas, such as best practices in closed system design.

Using a Closed System for Gene Therapy’s Smaller Batches 

While any drug development program can face pitfalls and uncertainties, developing cellular and gene therapies (CGT) present unique challenges above and beyond those encountered for bioprocessing’s small molecule drugs. A closed system designed for gene therapy manufacturing provides the protection of a cleanroom against outside contaminants without the costs associated with maintaining it. Closed systems are becoming widely used in SUT (single-use technology) facilities for monoclonal antibodies, recombinant protein and vaccine production while the adoption of closed systems at lab scale for smaller batches for CGT manufacturing is gaining ground. 

Simplify Gene Therapy Processes with CPC Aseptic Connectors 

 Easy-to-use CPC aseptic connectors help reduce system complexity and production costs by offering enhanced process flexibility and reliability. The simple integration of SUT plug-and play assemblies with quick connects for gene therapy eliminate the complicated process for connecting tubes via tube welding. Using CPC aseptic connectors means there is no need to bring a tube welding cart and all the necessary components into the production suite, and then moved to the biosafety cabinet to be put together. Gene therapy manufacturers designing production processes with quick connect single-use sterile connectors no longer experience the costs and delays associated with the extra time needed for open manual processes.

Improving Gene Therapy Processes with CPC Aseptic Connectors

  • Broad chemical compatibility
  • Performance integrity down to -80°C
  • Sterilization by gamma or autoclaving methods
  • Reliable, repeatable performance
  • Validation reports available
  • Minimal operator training
  • Broad product portfolio from benchtop to cGMP production

Secure and Sterile Connectors for Gene Therapy

With the labor-intensive and open nature of gene therapy manufacturing, production is highly susceptible to operator error and contamination risks. CPC sterile connectors for gene therapy, attached to the SUT, ensure a terminally sterilized, closed system process where each biologic drop is secure and sterile.

Single Use Technology for Gene Therapy

CPC aseptic connectors offer an easy-to-use method for flow path sterility and integrity during gene therapy manufacturing. These single-use connectors help deliver the necessary sterility protection to avoid costly failures from contamination.

When Sterile Connectors are Used For Gene Therapy

Sterile Connectors for Gene Therapy Benefits

  • Remove cumbersome steps in production
  • Minimize costs by closing operations that would normally be performed under the hood
  • Save time and labor during setup, production and between batches
  • Eliminate cross contamination in between batches
  • Reduce processing area footprint 

Sterile Connectors for Gene Therapy: Decades of Experience, Forefront of Innovation

CPC has been delivering aseptic connectors to the biopharmaceutical market for decades. With this extensive biopharma experience, CPC engineers have applied their single-use technology for gene therapy to sterile connector innovation. This laser-sharp focus directly led to CPC’s development of AseptiQuik®, Steam-Thru® and MicroCNX® Aseptic Connectors, exclusively designed and built for the complexities of upstream and downstream applications used in gene therapy process.

Technical Insights from CPC's Biopharma Experts

Effectively Securing Cell and Gene Therapies with Closed Systems
The implementation of closed systems using single-use technology has helped to deliver life-saving therapies efficiently and economically.
Benefit of Using Single-Use Connectors Over Tube Welding
A survey of bioprocessing industry professionals asked which method they prefer for their connection needs: sealable and weldable tubing or aseptic connectors.
Cell and Gene Therapies: A Guide to Single-Use Connections - 10 Transferable Lessons from the Bioprocessing Industry
Industry experts expect SUTs used in biopharma clinical trials and commercial production to play a role in the development and production of cell and gene therapies.
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