Sterile Connectors for Biosimilar Production

Starting with Biologics

Biosimilars are remarkably similar to an already-approved biologic, often called the “reference” product. Like their biologic predecessor, biosimilars are most often large-molecule drugs derived from living organisms such as humans, animals, microorganisms or yeast. Biosimilar manufacturing begins when the reference product’s patent expires, with research and development starting sometimes three to five years earlier.

Biosimilars Greatest Potential

Shorten time to market
Greater competition
Increased patient access
Lower patient treatment costs

Biosimilars Boost Promise of Reduced Drug Acquisition Costs

Data must show that a biosimilar product is “highly similar” to the approved reference biologic product. With a shorter approval process, bioprocessing companies use the data already established by the reference―saving time, resources and unnecessary duplication of animal testing or expensive human clinical trials. However, there are still costs and time involved in ensuring the biosimilar has no clinically meaningful differences in safety, purity and potency from the reference product.

Annualized savings from biosimilars reached $6.5B in the second quarter of 2020, and savings are modeled to exceed $100 billion in aggregate over the next five years.
IQVIA Institute Report (2020) Biosimilars in the United States 2020 – 2024

Small Changes Lead to Biosimilar Production Success

The complexity and sophistication of manufacturing of the original biologic also apply to the biosimilar. While comparable, biosimilars have their own set of manufacturing challenges. Biosimilars are created from modifications to the manufacturing process that closely resembles the reference biologic. These changes in the manufacturing process can affect the safety, efficacy, or potency of the biosimilar. With the promise of lowering drug acquisition prices, operational costs become a key challenge for manufacturing biosimilars.

Scalable, Faster, Efficient Biosimilar Processes

To help compete on price, biosimilar manufacturers must develop highly efficient upstream, downstream, cold chain and fill-and-finish processes to reduce the overall cost of goods while ensuring the reliability of the biosimilar. Media transfer management plays a large part in biosimilar production, helping not only reduce costs but optimize the safe handling of the media.

Using CPC Sterile Connectors in Meeting Biosimilar Production Challenges

CPC sterile connectors are a critical component to bring together single-use assemblies while maintaining a sterile fluid pathway. They are precision-engineered to connect one processing stream to another―such as a container to a sampling line, media to a vessel or a filtration process to a filling line.

CPC single-use aseptic connectors are a flexible, efficient and effective method to allow media to enter or leave a system flow path. The robust, easy-to-use design of the AseptiQuik^® portfolio of sterile connectors prevents unwarranted material exchange between the process and the environment.

Seven Reasons for Choosing AseptiQuik Sterile Connectors

Prevent process contamination
Maintain sterility
Increase application design flexibility
Offer a broad portfolio of configuration and size options
Streamline inventory requirements
Streamline inventory requirements
Manufactured by company with extensive experience

Aspetic-Genderless-Connectors

CPC’s Skilled Team Focused on Bioprocessing

CPC’s bioprocessing engineers are deeply familiar with the biosimilar production and their impact on media transfer in a single-use, hybrid or stainless-steel production system. With a strong emphasis on collaboration, our team works with your biosimilar processing experts to determine the best media handling connection solutions to maintain the highest quality, assure sterility, and deliver reliability. Our team, including materials scientists, design engineers and applications engineers, exclusively focuses on bioprocessing connectors, resulting in a robust portfolio of genderless, sterile and steam-in-place connectors and disconnects expressly for biosimilar production.

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