The Standardization of Single-use Components for Bioprocessing

The focus in the bioprocessing industry is shifting from acceptance of single-use technology to standardization. It is critical that components be included in the standardization discussion. The tubing connector is essential for secure, sterile, leak-free connections between various single-use systems and processes. A user can have the best filter, bag and tubing but this is all pointless if the connector is not reliable, easy-to-use or robust. Improving connector compatibility and interchangeability are great opportunities for standardization, particularly because of complications related to managing inventories.

Inventory Issues

Several inventory issues arise from lack of connector standardization:

• Increased ordering complexity because the user must define which tube set or assembly works with which part of the application. 
• Greater risks of specifying the wrong system or connection, resulting in downtime and last minute adjustments at the end user site.
• Longer lead times because systems suppliers are manufacturing lower volumes of multiple SKUs as opposed to higher volumes of fewer SKUs. This lowers the incentive and likelihood for a manufacturer to stock of these items.
• Increased stocking requirements for end users, including connectors of different genders and other components needed to create make-shift adapters.

Reducing Overhead Costs: Less is More

While overhead cost reductions might be difficult to quantify, they cannot be overlooked. Reduction in SKUs and inventory lowers the cost of managing and maintaining that inventory, which allows capital to be allocated to additional process improvements. One way to help simplify and reduce inventory is to use genderless connectors that enable transitions between tubing of different sizes. Using genderless connections (e.g. CPC’s interchangeable AseptiQuik® G connectors) eliminate the need for reducer fittings elsewhere in the process as the connectors can act as reducers.

Component Standardization

By focusing on the most versatile genderless connectors, component standardization will help bioprocessing companies make the best use of single-use technology. The right connectors will enable end users to:
• Streamline operations with easy-to-use, robust sterile connections
• Eliminate potential ordering mistakes and reduce inventory demands related to gendered connectors • Maintain more flexibility and lessen production bottlenecks with onsite connector assembly 
• Reduce overhead costs, freeing up capital for other projects

Ultimately, standardizing components by incorporating single-use genderless connectors lets end users accomplish more with fewer finished goods, saving time and money, and getting their biopharmaceutical products to market more efficiently. 


Author: Todd Andrews, Global Sales and Business Development Manager, Bioprocessing for CPC – Colder Products Company

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How can you achieve better integration for a biopharmaceutical firm?

Last week, BioProcess International conference producer Barry Walsh shared some of the newest emerging trends and technologies in biopharmaceutical production.  This week, Michael Keenan shares how these things can be better integrated into an organization to ensure that processes are better and more fluidly completed within the organization.  How does producer Michael Keenan think BioProcess International can do this?

How is this need for better integration at all process interfaces within the organization.being addressed and facilitated at the event?

As we were doing research for the event this year, we were really hearing from a lot of people a very common theme, which is how do we break down the barriers between process development and manufacturing and even within process development? Breaking down barriers between upstream and downstream, breaking down barriers between clinical and commercial manufacturing? Even breaking down barriers between discovery up to sort of process development, really trying to make the transitions more smooth and efficient.

So, one of the ways that we tried to create a more integrated program agenda this year was by creating the concurrent conference tracks in such a way that whether you are in upstream development or downstream development, formulations, delivery, analytical quality or manufacturing, there were opportunities throughout the program for you to get specific content related to your specific interest, but yet jump to another track or another session to give you an idea of what happens before your job or after your job to help you integrate.

We have shared sessions this year. I know the upstream and downstream track have their sort of track, but we bring them together for an integrated upstream and downstream session so that both of those groups can understand and learn from each other. We have plenary sessions with fantastic keynote speakers this year, from Amgen, Genzyme, 11 biotherapeutics, Bristol Myers Squibb then Novartis on a variety of topics that will bring the entire audience together for a real keynote session and sharing of information and integration of ideas.
For the analytical quality track and the formulation development track and the manufacturing track, we also have brought those together for a shared session on one of the mornings again to facilitate this interaction and inter-discussion so that people from different disciplines can really learn from each other throughout the program.

This is an excerpt from a podcast interviews series in coordination with BPI Magazine.  To hear the complete podcast along with other speaker interviews, download them by visiting this webpage.



Next week, we'll hear from producer Michael Keenan on how he and Barry have worked to tailor the program to reach the needs of the new, emerging trends in the industry.

If you'd like to join Barry in Boston this coming September 16-19 at the Bioprocess International Conference, as a reader of this blog when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate! Have any questions? Feel free to email Jennifer Pereira.

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