Tony Hitchcock, Head of Manufacturing Technologies at Cobra Biologics explains best practices on the implementation and integration of multi-component disposable systems, maximising economic benefits and utilising new biomanufacturing models, while considering how the East compares to the West in this market.
Pharma IQ: Tony, could you give us an overview of the work that you’re currently doing at Cobra Biologics?
Tony Hitchcock: I’m involved as a contract manufacturer, so my work involves day to day interactions with our operations group to try and improve operations within the company, but also to work very closely with our potential customers to try and better understand their projects, and also to understand solutions that Cobra may provide to them.
We’re involved in a wide range of challenging programmes from making monoclonal antibodies through to production of recombinant viruses, and also novel therapies such as bacteria phage.
Pharma IQ: Obiously Tony, the Pharma Industry is growing massiely on the East, what are the main differences, between the Eastern and Western market in the disposables industry?
Tony Hitchcock: I think that the single use systems have been widely established in the US and in European markets and suppliers are now recognising the opportunities within the Asian market, but also to look into trying to respond to their needs in terms of supply chains, and also the greater cost sensitivity within Asia, so I think as the suppliers understand the market it’s now appropriate to start trying to sell and develop those markets in the single use technology areas.
Also, I think there’s greater development of new therapies within the Asian market of people looking at node therapies and also biosimilars, and traditionally that’s been the area that single use systems have most predominantly been used as opposed to very large market supply projects.
Pharma IQ: What are the main talking points in disposables for biomanufacturing today?
Tony Hitchcock: The main areas include looking at greater integration of quality systems and understanding how companies can better work together to provide solutions for that.
There’s still ongoing issues about how we’re getting greater integration of systems, areas of technology or probe sensors, for instances, where people are trying to be very innovative in looking at single use sensors for pH pressure and oxygen tension, some of those are working very well, but some of them have slightly greater limitations than some users would like, but I think there’s a great deal of work going on that.
I think there’s also a greater knowledge and understanding of issues about extractables and leachables and companies trying to find logical risk based solutions to address potential concerns around those areas.
Pharma IQ: One of the limitations around some disposables right now is they’re not as robust as maybe their steel counterparts. How does that affect situations where vaccinations are involved?
Tony Hitchcock: I think it has to be very much a risk based approach of people actually assessing what their process involves, such as, the potential risks of the organisms that they’re processing, go through standard engineering, or good engineering practices such as hazard and operability studies, and trying to make an assessment firstly whether single use is appropriate for their operations in terms of the impact on operators, and potential environmental hazards.
A lot of that relates to actual operating procedures, as well as the design of the actual units themselves. The greatest risk, I feel, is the actual making and breaking of connections between units, and also the high level of manual operations that you’ll see in single use systems compared to what you might traditionally have with a more fixed stainless steel plant where there’s greater scope for automation within the units.
Pharma IQ: Can you give us some tips on establishing best practices on implementing and using single uses systems?
Tony Hitchcock: I think best practices relate to trying to understand how single use systems impact your whole business, rather than just small areas of the business. It’s quite apparent that to try and get best practice going you need to work with a wide group of individuals, not just an engineering group.
You very much have to involve the operations staff in working out how you can best develop a process potentially from scratch rather than trying to just replicate the stainless steel system, so I think you have to again go back to understanding strengths, limitations of single use systems and develop processes around that, it has to be a very proactive design process to try and best use these systems and understand how they can be best employed within a facility.
Pharma IQ: How organisations can better integrate solutions?
Tony Hitchcock: Gaining an understanding on how the units will best impact the whole business, is important, and that involves quality groups, supply chain management and understanding the impact it has on materials flow for the facility.
It’s quite apparent that, for instance, that these systems require much greater storage area than might have traditionally in a stainless steel facility. An organisation also has to consider how they will take materials through a facility and dispose of them. Again, you need to very much involve quality groups, all levels of operational groups within the business, so I think it’s got to be a company-wide approach and adoption system rather than coming from a single group, such as an engineering group imposing a solution onto people, it’s got to be very much a bought-in process.
Pharma IQ: Are there any best practices or ways to standardise procedures within this market?
Tony Hitchcock: I think it’s good to look at standardisation within a particular market. It’s apparent that the suppliers, for instance, have their own individual approaches to it. I have attended meetings and heard people citing that there’s about nine or ten different connection systems between different bags and components, I think at the moment the suppliers are unlikely to standardise in those types of areas because they feel it restricts their capacity to innovate.
But there is a need to standardise within companies to reduce the number of components and materials across a site and between organisations so there are a greater reduced stock levels, and also reduce the actual cost of materials stored on site. So, it’s going to lean practices and standard good business processes to try and achieve those standardisations, so what you’d try and avoid is actually have individual groups within a company trying to select their own particular vendor or particular solutions throughout it. Again, it’s looking at more company-wide procedures to standardise within your organisation.
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