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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Don’t Miss BPI West!

Last chance to register for BPI West is March 9th. Use the code BPIWEST16BL and save $100- Register now!

The clock is ticking. BPI West is just over a week away! Don't miss out on networking with industry experts, scientists and executives, along with emerging and established technology companies. Your registration will gain you access to:

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PLUS! We're excited to announce that Michael Egholm, President of Pall Biopharmaceuticals joins the upcoming BPI West event in Oakland on March 14th! Join us as he provides an update on the Significant Technology Advances Enabling Integrated Continuous BioProcessing during Monday's The Future of Continuous Processing pre-conference symposia. Best of all, this session is complimentary to all registered attendees!



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8 Reasons Why You Can't Miss BPI West | Plus! Register by Friday, 1/22 and Save $400

8 Reasons Why You Can't Afford to Miss BPI West:

1. First and only phase-based format event that fosters the collective sharing ideas, strategies and solutions across departments to improve speed, cost and quality at every stage of development
2. Breakdown the barriers and collaborate across stages of development to achieve end-to-end integration
3. Discover the latest breakthroughs on successfully implementing continuous processes and linking them together to achieve fully continuous processing from cell culture through to drug substance
4. Accelerate the design and development of novel drug substances for next generation therapeutics by integrating candidate selection and early development
5. Develop strategies for fast tracking early stage biologics and managing the life cycle of a break through therapy designated product
6. Speed up and streamline the transition into development by utilizing manufacturability assessments, automation, and QbD in late stage discovery and R&D
7. Implement disruptive technologies and achieve operational excellence to drive manufacturing efficiencies and minimize costs
8. Uncover the future of single-use systems and next generation facility design, modelling and management in current and emerging markets

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This Week in BioPharma: 8/3-8/7

Here is the top news from the biopharmaceutical industry this week:

Biotechnology is helping to heal Delaware: Nearly 22,000 women will be diagnosed with ovarian cancer this year. Another 14,000 will die from the disease. One Delaware biotech firm is working to change that. In December, Wilmington-based AstraZeneca Pharmaceuticals released Lynparza, a new medicine for women with advanced ovarian cancer. Innovative treatments like Lynparza help Delaware patients live longer and healthier lives. Drug development also keeps Delaware's economy healthy by creating jobs and supporting local businesses. But now, Congress may jeopardize the health of our state and its residents with ill-advised changes to Medicare Part D and patent laws. Read the full post here.

U.S. officials warn medical devices are vulnerable to hacking: The federal government is warning about a medical device that could be tampered with by hackers. The FDA and Department of Homeland Security issued a statement that "strongly encourages" health care facilities to discontinue the use of Hospira's Symbiq infusion pump after officials learned the devices are vulnerable to cybersecurity threats. The medical device company confirmed that the computerized pumps -- which continuously deliver medication over an extended period -- could be accessed remotely through a hospital's network. This could allow an unauthorized user to control the device and change the dosage of medication the pump delivers to a patient. Read the full post here.

Allow medical devices sector to work with doctors: Pitching for allowing medical devices industry to engage doctors, industry body CII today said preventing medical practitioners to undergo training about latest technologies may be detrimental. Currently, under the voluntary the Universal Code for Pharmaceutical marketing Practices (UCPMP) industry is not allowed to engage medical practitioners for continued medical education on latest technologies, CII said in a statement. "Medical Device Industry is an innovation driven industry and needs to work with medical practitioners as well as paramedical professional in close proximity," the industry chamber said.  Read the full post here.

How can we derisk innovation in pediatric medical devices?: Sometimes, kids need intensive medical treatment – and the tools used for adults aren’t necessarily suitable to treat smaller, growing bodies. This presents a unique challenge for surgeons and clinicians, who find themselves with limited options when treating sick children. That’s where the Sheikh Zayed Institute for Pediatric Surgical Innovation comes in. It’s a division of the Washington, D.C.-based Children’s National Health System – and focuses on making pediatric surgery more precise, less invasive and, ideally, pain-free. Kolaleh Eskandanian, executive director of the Institute, spoke with MedCity News about the unique challenges in pediatric medical device innovation – and ways they’re helping jumpstart entrepreneurship in this small but important market. Read the full post here.

Technavio Says the High Demand for Biopharmaceuticals Will Inflate the Global Single-use Bioprocessing Systems Market Through 2019:  Technavio has published a new report on the global single-use bioprocessing systems market, which is expected to grow at a CAGR of more than 34% from 2015-2019. The new report indicates the increase in the aging population is leading to a rapid increase in patient population suffering from diseases such as diabetes, hypertension, musculoskeletal and cardiovascular diseases, chronic kidney diseases, cerebral strokes, and cancer. This increases the demand for biopharmaceuticals among patients. Read the full post here.

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Increasing the flexibility of fill finish operations with single-use technology

There are many benefits to using single-use technology for the manufacture of biopharmaceuticals. The enabling aspect of the technology that allows closed-system processing has been examined in a previous post. The single-use principle can be applied across the biomanufacturing process with bioreactors, chromatography and cross flow filtration all available in single-use formats.

Single-Use and Fill Finish

The role of single-use in adding flexibility to fill finish operations will be the subject of a presentation given by Chris Smalley, Ph.D., from Merck & Co. at the Bioprocess International 2015 Conference that will be held in Boston in October. Chris’presentation will be part of the ‘Drug Product Manufacturing & Fill-Finish Processing’ track which is new for this year.

In a recent interview, Chris highlighted the fact that single-use technologies can play an important role in helping to rapidly establish global networks of fill finish operations. These are required in order to meet emerging demands (Merck Champions Single-Use ByAddressing Emotion Vs. Science, by Trisha Gladd at Bioprocess Online)

One way of developing such a network will be to utilize existing manufacturing locations and staff. Minimizing the amount of work required to redevelop these existing facilities around the world will be crucial in achieving the level of operational agility that will likely be required. Taking a single-use approach to fill finish will allow this by reducing the need for HVAC, cleanrooms and WFI systems. The affordability of drugs can be improved as the capital costs, labor requirements and time needed to design and build new facilities will be reduced.

Particulates and Extractables

In the article, Smalley addresses two common concerns about single-use technologies that are particularly pertinent during fill finish operations, namely, particulates and extractables. These are especially important issues for fill finish because there are no further processing steps that can remove impurities derived from equipment or consumables at this stage in the process. Smalley believes that the available studies show that there is little or no risk to patients from particulates and he is an advocate of suppliers providing adopting the BPOG guidelines with respect to extractables.

To facilitate the implementation of single-use across the company, Merck have a Single-Use Network (SUN) of advocates that set guidelines and define good practices. Smalley sees standardization as a key success factor for single-use implementation within the industry. He will no doubt be interested in participating in the Town Hall Forum Discussion on single-use technologies with industry organizations such as BPSA, BPOG, PDA, ASME BPE and ASTM.

Have your say

To what extent do you think challenges, such as particulates and extractables, relating to the implementation of single-use technologies can be overcome?

Dr Nick Hutchinson

Join me at #BPIconf

Contact me at nick.hutchinson@parker.com

Dr Nick Hutchinson has a Masters and Doctorate in Biochemical Engineering from University College London, UK where he focused on laboratory tools for rapid bioprocess development and characterization. He then worked at Lonza Biologics in an R&D function investigating novel methods for large-scale antibody purification before moving to an operational role scaling-up and transferring manufacturing processes between Lonza sites in the UK, Spain and USA. Nick now works in Market Development at Parker domnick hunter where his focus is in bringing Parker's strengths in Motion & Control to Bioprocessing. This will enable customers to improve the quality and deliverability of existing and future biopharmaceuticals.

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