Express Pharma

‘Single-use system improves sterility’

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Pavan Urs M, Regional Sales Manager, India, Colder Products Company (CPC), talks about the necessity of single-use system for the Indian bio-pharmaceutical industry, in a discussion with Sachin Jagdale

What are the advantages of single-use systems and how are they relevant to India’s bio-pharmaceutical industry?

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Pavan Urs M

One of the key advantages of single-use systems is their ability to increase speed to market while enhancing cost efficiency. Traditionally, biotechnology research centres spend significant time and cost in building and retrofitting their manufacturing facilities. Upon completion of the research, time and cost is further spent in the planning, redesigning and scaling up of their production processes. Single-use systems hold the potential to overcome these challenges as plants designed around them are typically less complex. Faster set up, reduced capital requirements for new builds and smaller facilities footprints are made possible, allowing bioprocessing companies to devote their resources to researching and developing more profitable products. Notably, the use of single-use systems in the production stage also means that cross contamination risks and cleaning requirements are all reduced.

As India’s bio-pharma industry advances rapidly, higher standards are being expected from the region and Indian firms are challenged with having to keep up with international standards and regulations while keeping their costs low. Single use systems allow manufacturers to benefit from improved sterility assurance, quality control and shorter validation cycles that are critical to remaining competitive in the bio-pharma industry.

What are the characteristics of quality single-use systems?

In general, users can evaluate the quality of single-use systems from three aspects. The first consideration is the safety and durability of the technology. Many global pharma companies recognise the importance of this and only choose to work with industry-accredited partners such as those with the ISO 9001:2008 certifications. It is also common for them to conduct comprehensive testing, ensuring the safety and durability of the technology before purchase. Secondly, users need to consider if the single-use system of their choice is designed to meet the goals they wish to achieve in their bioprocess. The third consideration is ease-of-use. Intuitive, user-friendly designs can significantly reduce the risks of manual operation errors that in turn can threaten the safety of the user and quality of the final product.

Could you give an example of how a single-use system is used in pharma R&D?

Closed single-use systems used in research (R&D) and process development (PD) cell culture applications is an apt example. Such systems reduce the risk of two critical forms of contamination: biological contamination and cross-contamination. Biological contamination includes competitive organisms such as bacteria, fungi and yeasts that are inadvertently introduced into cell culture processes. These organisms utilise culture nutrients, produce unwanted proteins and limit growth or destroy the intended cell culture. Most biological contaminations result in rapid growth and observable culture changes that indicate a culture must be discarded. However, slow growing contaminations can be subtle and may only become apparent when unwanted proteins are detected. In either case, biological contaminations are costly due to wasted time and materials. Cross-contamination results from protein residues from cell culture and processing equipment that is reused without proper cleaning or that may migrate between two different processes that utilise open systems. These residual proteins might inhibit proper cell growth or, if they are structurally and chemically similar to the target protein, they pass through purification with the target protein and yield inconsistent results. For R&D and PD applications, closed, single-use systems can protect against both biological and cross-contamination, saving valuable research time and money.

Flexibility is critical in pharma R&D. Can sterile connectors offer such flexibility? What are some innovative connectors that bio-pharma professionals should be aware of?

Sterile connectors with appropriate features can provide the necessary flexibility. For instance, bioprocess engineers who may want to combine sterile connect and disconnect functionality all in one connector, eliminating the need for a custom assembly with tubing, can consider integrated combination connectors. An example of this type of connector is CPC’s AseptiQuik DC. With this connector, a sterile connection can be established in a simple, three-step process that allows sterile liquid transfer in a few seconds. After liquid transfer, an aseptic disconnect can be made in a single step that takes just another second or two to complete.

Similarly, a connector that combines sterile connect and SIP (steam-in-place) capability is also an integrated combination connector. Such connectors are typically needed in biopharma processes using a hybrid combination of stainless equipment and single-use systems. Using CPC’s AseptiQuik STC as an example, a 3/4-inch mini sanitary junction is used to integrate a sterile connector directly with a SIP connector. This provides the user the flexibility to SIP the combination connector to the stainless equipment in advance and then utilise the AseptiQuik sterile connector to quickly connect any number of different manifolds or bags systems when it is time for product transfer without the need to wait 30-60 minutes to perform the SIP cycle. The sanitary junction provides a more secure connection and reduces the number of potential leak points associated with use of a length of tubing between the connectors.

As the leading innovator of connection solutions, CPC has been at the forefront of technical innovation. How will single-use systems continue to advance/ develop?

With regards to the use of single-use technologies, two of the biggest trends we see in the industry are the transition toward more closed systems and the drive toward modular system design. Sterility assurance is a major factor in the adoption of closed systems, as the leading provider of connectors we see an associated conversion toward sterile connectors. This trend is often tied with manufactures moving to greater utilisation of modular system design as they work to reduce the number of different custom assemblies they purchase – thus driving greater volume into a limited number of modular sub-assemblies that can be assembled together to create a wide range of flexible plastic based process solutions. Such sub-assemblies designs are further simplified by incorporating genderless connectors that minimise the required number of configurations create greater harmonisation and streamline supply chain requirements.

The short-term future for single-use technologies include: continued adoption, the push toward standardisation of industry requirements (an example would be extractables testing harmonisation), the adoption of modular system designs and continued innovation within component technology and system offerings to address both upstream and downstream requirements.

How have some of your clients in India made use of CPC’s products?

Many of our customers in India are vaccine manufacturers. In general, CPC’s products have helped our customers in India make the transition from stainless steel to disposables. For instance, instead of stainless steel fittings, customers make use of CPC’s MPC quick disconnect couplings in conjunction with laminar flow hoods for quick, easy and secure connections. Additionally, CPC’s Steam-In-Place (SIP) connectors have replaced the traditional manual T valves to simplify hybrid system integration, while its aseptic connectors allowing sterile transfer and disconnect in an open environment minimising risks while replacing the industrial grade QRC.

India is a cost-sensitive market. How are you going to keep your services valuable to Indian bio-pharma companies?

At CPC, we believe that innovating and developing new technology is driven by both suppliers as well as users. We recognise that drug manufacturers in India are constantly looking for solutions that enable them to cost effectively develop and introduce new therapies on a global basis. As suppliers, we are constantly working with our customers to identify and address these needs with new connection solutions that improve the overall functionality and design of their existing equipment and processes. We focus on bringing true value, such as quality, reliability, flexibility and efficiency that are required to stay ahead of competition.

CPC innovates on the leading edge of what is possible and collaborates to develop the best solution for each customer. Many of CPC’s standard couplings and fittings began as custom engineered solutions that found broader use in applicable markets. To date, CPC has produced over 10,500 custom and standard products to meet the fluid handling challenges of various industries worldwide.

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