Since 2016, BioPhorum Supply Partner has made great progress in bringing together manufacturers and supply partners to build modern and effective inbound supply chains and develop a program of work that addresses some key areas: risk; planning; and education, qualification and control.
Its industry expertise and ‘horizon scanning’ mean its transformative program reduces risk and adds value for members. This can be seen in the creation of two exciting new workstreams: ‘Electronic Data Exchange/Digitization of the In-Bound Supply Chain’ and ‘Alternative to Gamma Sterilization’.
Do you want to be part of this drive to improve the resilience and agility of the industry?
Electronic Data Exchange/Digitization of the In-Bound Supply Chain
BioPhorum’s 2017 Biomanufacturing Technology Roadmap identified that electronic data exchange (EDE) is a key industry need. EDE allows the integration of supply partner and manufacturer systems to improve the efficiency, reliability and robustness of supply chains and manufacturing processes. It also enables the move to the real-time release of bulk drug substance.
Industries such as automotive and aerospace are well advanced with integrating supply chains using electronic data interchange (EDI), the process of electronically communicating information that traditionally used paper, e.g. invoices. The adoption of EDI is needed for EDE to be successful.
Yet, the adoption of EDE in biopharma has been slow, partly because its industry importance has been poorly defined and a standard ‘language’ has only recently been agreed. There are also concerns over the security and integrity of data, and a lack of a standard way of defining content, which risks divergent solutions.
This is a huge lost opportunity for the industry. Problems include reduced speed and agility while increasing its timelines and costs, and information is not in useable and accessible digital formats. It also prevents the creation of data-driven product quality and process improvements.
We need a way for end-users and supply chain partners to collaborate on how to accelerate the uptake of the EDE of raw material and consumables data.
This is why the Phorum has formed the Electronic Data Exchange/Digitization of the In-Bound Supply Chain Workstream, which is recruiting subject matter experts to help deliver its goals, which are split into three phases.
The first includes developing a definition of EDE and how to revolutionize the in-bound supply chain. Phase 2 will look at how to implement standards, such as the ASTM e3077 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical and Biopharmaceutical Manufacturers. The final phase will focus on industry readiness and the process of tracking adoption and templating for key information transfer requirements.
Being involved with the workstream will have many benefits. Members will help drive the uptake of EDE to increase speed, flexibility and access to data. They will also help influence richer data analysis and processing to boost process optimization and investigations. Tonya Jackson, Biologic Solutions Platform Manager at BASF said, “It is great that BioPhorum Supply Partner is taking the initiative to support the adoption of Electronic Data Exchange for the in-bound supply chain”
Alternative to Gamma Sterilization Workstream
Gamma radiation has been used in biopharma for many years to sterilize single-use systems (SUS). It relies on Cobalt 60 as the source of the gamma ionizing radiation required for sterilization – but has major limitations in its facility locations, sourcing/transport of materials and regulations.
However, the leading supplier of gamma sterilization services has decided to diversify its sterilization technology and, while continuing to support its existing gamma facilities, will instead focus on x-ray technology.
This will have a massive impact on the industry. The Bio-Process Systems Alliance (BPSA, the US trade association for manufacturers of single-use technologies) has started identifying issues and capacity limitations, and their impact on the industry. If SUS demand continues and access to gamma sterilization capacity becomes limited, this will only increase costs, manufacturing delays and lead times. The BPSA has indicated this industry-wide constraint is likely to start impacting in 2022–23.
The Phorum has therefore created the Alternative to Gamma Sterilization Workstream, which supports the BPSA activity. It brings together suppliers and biomanufacturers, which need to understand this issue and its impact on SUS supply chains. As well as exploring the opportunities for process improvements that x-ray might offer (e.g. in fill finish), the workstream will present a unified approach to the validation work required to gain regulatory approval. “Supply chain resilience is important to the biopharmaceutical industry. Having access to alternative technologies to help our industry manage business continuity is a good thing and I’m happy to see BioPhorum Supply Partner take this on as a workstream,” said Dominic Moore, Director, Supply Chain, Northborough Biologics at Sanofi.
The workstream is now defining its charter before recruiting subject matter experts to help design, develop and deliver its approach to the gamma sterilization situation.
The workstream goals include helping industry understand the impact of this move to x-ray, gain acceptance by regulators for x-ray sterilization methods, and ensure a balance in the supply chain between gamma and x-ray sterilization.
Being involved with the workstream will have lots of benefits for members. These include influencing business continuity (e.g. access to alternative sterilization approaches in different parts of the world), improving processes and lead times, and creating flexibility for accepted sterility options. It means that suppliers and manufacturers will have a crucial part to play in influencing the solutions that will be proposed to regulators.
If you want to be part of either workstream and be able to influence industry change, please contact the BioPhorum Supply Partner Leader Bob Brooks on [email protected]