Process Development Forum speaks with Jeff Carter, Strategic Projects Leader at GE Healthcare, and first Vice Chair on the executive board of the Bio-Process Systems Alliance (BPSA).
What general trends do you see in single-use technologies within the biopharmaceutical industry?
We are now seeing standardization of materials testing data and corresponding analytical techniques across the industry through trade associations like BPSA and BPOG. This development will lead to the increasing availability of high quality single-use material information which, in turn, will provide greater technical insight to process performance. This will help to address one of the industry’s top concerns – that single-use materials need to be effectively controlled and characterized so as to properly understand their potential impact on process performance or quality.
BPSA and BPOG are also bringing suppliers and users together to collaborate on new initiatives. A few examples are BPOG’s Supplier partnership program (SPP), a change notification committee and co-establishing single-use system user requirements.
There is a lot of discussion on standardization on Extractables & Leachables (E&L) studies. How do you see this is evolving?
There are two things that are happening in parallel. BPOG created a standard URS with several documents which has been distributed to its members. These members are asking their key single-use suppliers to cascade and implement these needs within their supply chain. Some suppliers have already began to work through the BPOG protocol using a risk based approach. This will likely be a de facto standard and not something a standard setting body such as ASME will implement. There is another group saying there are technical issues in implementing the BPOG protocol which may lead to slower industry-wide adoption. There are also concerns relative to the financial investment, technical resources, testing capabilities and timeline required to implement the complete BPOG protocol.
ASTM is also working on writing an industry-wide E&L standard. They are considering some of the limitations and challenges identified in the BPOG protocol and seeing what can be done to develop a more realistic standard. This will take a few years to develop. Nonetheless, when we do have an industry best practice it will likely have origins from the original BPOG document from 2014.
One of the key challenges we will face is how we as an industry are going to work through the timing expectations and implementation issues described earlier. Over the next several months, we are likely going to see the BPOG protocol has technical deficiencies and how we work through the experiments to prove or disprove these concerns is going to be important. Because the BPOG protocol has at least a two year head start on a protocol from a voluntary standard setting body, we can potentially end up in a situation with two best practices. We will likely see some degree of natural selection transpire with either companies staying with BPOG because they will have become invested in it or companies migrating away from it if they see it to be too costly, not universally asked for, or if it has too many technical issues.
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