What is your name and your involvement to SDD™?
My name is Javier Lozano, I am the Technical Lead for the SDD™ innovation, as well as the Process Engineering Head of Department for PM Group in the UK.
Can you explain about SDD™ – what is it and why are you passionate about it?
SDD™ is a global innovation developed by PM Group in collaboration with pharma end-users and suppliers. It aims to standardise single-use assemblies used in the biopharma industry as part of buffer and media operations.
The initiative covers 350 standard assemblies and offers huge benefits to the pharmaceutical industry. It is helping to deliver drugs to market faster by reducing the cost of manufacture and producers’ stock levels of key components. It facilitates global availability of standard components through networks of suppliers, enhancing security of supply.
Would you kindly explain how SDD™ can benefit the Supplier Community?
Single-use technology is moving from the clinical space into commercial manufacturing. The extensive use of custom assemblies in the industry means that suppliers have to manage thousands of designs and SKU. Many of these are exclusive to one client and/or process. This approach is creating a very complex logistics chain for single-use suppliers.
The SDD™ innovation does not define films or filters, only dimensions, sizes and type of connectors. Therefore, the wide adoption of SDD™ simplifies inventory management and at the same time, supports innovation and differentiation.
Would you kindly explain how SDD™ can benefit the Innovative End User Community?
The decision to use an SDD™ assembly will reduce its lead-time. Lengthy discussions with suppliers, assembly details and approvals are all removed from the process. Drawings are already available and end-users can access them before placing an order.
SDD™ allows easy comparison between different suppliers’ solutions, which help to drive down the costs of single-use technology.
Benefits also include a stronger supply chain. It facilitates dual sourcing of components and reduces the need for warehouse capacity.
What is your understanding of BioSolve Process?
BioSolve Process is a leading industry software, which allows us to develop mass balances, equipment sizing and cost analysis for all type of biopharma processes. It is a key tool in PM Group’s digital project delivery and it is used by a high percentage of our clients.
Why did you think it would be beneficial for SDD™ assemblies to be incorporated as part of BioSolve Process 8?
Using the extensive BioSolve Process client base, we hope to reach more end-users and raise industry awareness of the SDD™ innovation.
How can it potentially benefit our BioSolve Process user community?
BioSolve Process users will be able to easily see the benefits that using SDD™ will bring to their processes and facilities, doing quick comparisons between using SDD™ and bespoken designs.
BioSolve contains all the SDD™ assembly codes so it is easy for the user to access in one place. From here, they can also access the assembly drawings direct from the various suppliers’ websites. Using the codes, accurate quotes can be sought from the suppliers. In this way, users are streamlining the whole design of their single use process.
What is the next step for SDD™ activities?
We are continuously working on getting more suppliers into the initiative so that end-users have more choice when deciding which assemblies to use.
We are also looking at possibilities for extending the field of application of SDD™ evaluating the opportunities in Cell & Gene Therapy and Fill/Finish.
During the year, we will publish a white paper detailing and quantifying the benefits of SDD™ in a mAb facility.
Additionally on the back of SDD™, we have also developed what we called the Single-Use Design Tool™. This helps the end-user to design their single-use process, auto-generates component lists for parts/assemblies which can be sent directly to suppliers for costs. It is available for use on a licence basis.
Do you think SDD™ will change the industry and if so how?
We are very optimistic about the opportunities for SDD™ to change the industry. Using the same designs across different sites and companies will help to simplify technology transfers.
Additionally, the use of standard designs will reduce the required warehouse spaces in a new facility. Importantly, it will facilitate the double sourcing of single-use components leading to stronger supply chains in the industry.
What three words would you use to describe BioSolve Process?
Agile, relevant, accurate.