Global bio-processing industry is undergoing major changes, one of the most significant of which is the shift to single-use systems (SUS).
With the rapid transition toward closed systems and the shift to modular system design, globally manufacturers are actively working to reduce the number of different custom assemblies they integrate into their processes.
Globally, over the last 20 years, the continued growth of single-use processing in commercial production has also led to the partial replacement of stainless steel equipment, and conversion to hybrid and completely single-use processing in commercial production is expected to continue. It is estimated that the size of the SUS market in globally at around US$30 million and India market size is US$2 million. The vaccines and bio pharma sector account for 60 per cent of SUS applications.
The use of single-use systems and components has provided many advantages to the global bio-processing industry. The primary benefits of SUS is increased safety and product quality. It drastically reduce cross-contamination risks and improve sterility assurance and when compared to traditional stainless systems, they also reduce product loss and make it easier to produce multiple products within a single facility.
Another advantage of SUS is lower operating costs. By using single-use systems, the bio-processing industry could reduce capital investments for new facility or retrofits of existing facilities. With the production of small molecules, drugs and biosimilars, the reduced cost advantage of SUS is almost instant. Further, the SUS components also increase speed-to-market, operational efficiency and flexibility. Because facilities take less time to build and have shortened validation cycles, implementing single-use technologies help address the challenge of developing and introducing new therapies.
Disposable bio-processing technologies increase process flexibility by providing the ability to manufacture multiple drugs in the same facility and to quickly convert production of one product to another. Because there is less cleaning required with SUS, there is less process downtime, which increases operational efficiency. These systems also increase sustainability, requiring less water, energy usage and fewer cleaning chemicals than traditional stainless processes. At the same time, there is no need for disposal of harmful chemicals, which accounts for a more sustainable and environmentally-responsible bio-processing industry, said Ernest Chan, director of sales-Asia Pacific, Colder Products Company which is a leader in the single- use connection technology.
Chan who was in India for the PharmaLytica 2014, held in Bengaluru told Pharmabiz that there is a visible shift from stainless steel to single- use systems.
“Companies are keen to opt for the same because cleaning of stainless production units is cumbersome. It would also curb the wastage of water and chemicals used to clean up units. SUS is economical in the long run because it saved time and manpower costs and also are safer for the environment,” said Chan.
According to Pavan Urs M, regional sales manager- India, CPC, every time a batch production was scheduled, there was need for companies to go in for a validation and this would lead to loss of time. SUS has made manufacturing flexible because all that one had to do is to change components which is simple. It keeps issues of contamination at bay.
The Minnesota-based CPC is engaged in the design and production manufacture of single- use connection technology. Its range of connectors have revolutionized processes in the bio-processing cover production of vaccines and biological products. Its range include sterile connect, sterile disconnect, SIP connection and quick connect which help increase process flexibility.
According to the company these products provide flexibility to biopharmaceutical manufacturers to easily combine multiple components, single - use or hybrid systems including process containers, tubing manifolds, transfer lines, bioreactors and other bioprocess equipment. India is the largest manufacturer of vallines globally and biopharmaceutical industry is on a growth curve. Therefore CPC views ample growth prospects in the Indian market.
Its AseptiQuik is a family of connectors giving Indian manufacturers even greater flexibility for both hybrid stainless steel and single-use processing. The AseptiQuik STC family of sterile connectors comprise the AseptiQuik G, a genderless option, and the AseptiQuik C, a gendered option. The AseptiQuik G eases integration of single-use systems with universal mating between AseptiQuik G connectors, thereby simplifying system integration. The innovative three-step connection process of the AseptiQuik C reduces the risk of operator error.
According to the company, both the AseptiQuik G and the AseptiQuik C are also offered with an integrated Steam-Thru II SIP connector, giving manufacturers greater flexibility for hybrid stainless steel and single-use processing. The Steam-Thru II connection features a three-port steam design and allows a quick and easy sterile connection between biopharmaceutical processing equipment and disposable bag and tube assemblies. The Steam-Thru family of SIP connectors was awarded the Technology of the Decade Award by BioProcess International in 2012.
Its connectors offer robust construction that ensures repeatable and reliable performance. The patented steam valve design allows sterile connection and disconnection to stainless equipment and permits a high media flow rate. The CPC click provides an audible confirmation of assembly steps to reduce the risk of operator error. The union of the AseptiQuik and Steam-Thru II connectors into a single unit through a sanitary clamp allows an AseptiQuik sterile connection to be steamed on to stainless equipment via SIP.