Watch this on-demand webinar to find out how your CMC teams can automate document creation and lab processes to accelerate workflows

Dennis Curran, Portfolio Director, BIOVIA

In today’s pharmaceutical industry, the increasing complexity and diversity of therapeutic product lines as well as the acceleration of clinical trial processes have made the organization of chemistry, manufacturing and controls (CMC ) increasingly critical on the way to commercial product launches. Accelerating the delivery of new, innovative and effective drugs to patients will therefore require the end-to-end digital transformation of CMC processes.

In this free SelectScience® webinar, now available on demand, BIOVIA Product Manager at Dassault Systèmes, Dennis Curran, discusses a digital lab solution that enables cross-domain integration and real-time, consistent, synchronized and standardized information flow from the R&D to manufacturing.

Read on for highlights from the live Q&A discussion or register now to watch the webinar at a time that suits you.

Can you handle all the recipes from the lab to manufacturing?

DC: Following the concepts I mentioned earlier, a recipe has a construction of materials, process steps, and equipment dependencies. The ability to manage all these recipes is made possible by our ability to have basic data, to have our customers define “here is my specific site, my specific equipment” and to map them to it.

The definition of the process is as follows: “Here are my vocabularies for performing these operations, this set of operations”. We have some standards, but when a customer has a specific recipe that can be out of the box, like a new area that we haven’t reached yet, we can create these process definitions, process parameters and these set points.

So yes, we can handle all recipes from the lab to manufacturing – we have a huge variety out of the box. If there is a standard ontology, we want to use it because it is a faster diffusion of knowledge, but if there is a new specific domain, a new domain, what we do is d ‘first build the foundation.

Here’s the definition of the process, here are the dependencies, and then we’ll overlay the process steps. Our goal would be to create repeatable steps to reduce the burden of development, validation and testing. As I mentioned, we’re looking for commonalities, and I cited USP as a specific example, where we want to target the availability of 5,000 out-of-the-box USP methods.

Next, we look at the ASTM methods for customers who might have different material testing needs. We’ve evaluated them and know we can build these ASTM methods as standard, out of the box. We look at the USP content, we look at EP and JP, the Japanese Pharmacopoeia, and put them into the system.

So, yes, the system is designed with the extensibility to handle all recipes for making substances, finished products, tablets, combination products as well as testing those given to structure S88.

Can we use JMP, GraphPad, etc., via BIOVIA?

DC: Yes, we can absolutely support this exchange. From an experience design perspective, JMP, GraphPad, we have a lot of integrations with this type of thing. SAD allows me to identify these parameters. When I do a design of experiments and want to vary the perimeters, I can send those settings or this definition to this third-party app and then bring back the number of experiments or the new setpoints.

What data format are you standardizing on?

DC: We are committed to supporting several different formats. This is not a singular response. There is so much variety in the world, especially in the data formats. We fully support the Allotrope data standardization initiative around analysis devices, the Allotrope Data Format (ADF). We have the standard ability to write and read in this ADF format. But in many cases, exchanging data could be easier than that. Thus, we also support basic AnIML or XML exchanges. If a transaction is to be fast, an exchange with an instrument, then CSV is also something that we do a lot. We are committed to supporting multiple standards. We like the ADF format a lot, but there are other competing standards out there and we will support them for the foreseeable future.

LC-MS involves data collection, data analysis and reporting. How is this type of experimentation managed?

DC: It is this third type of data exchange that I mentioned. It’s not just a rich file export, but there is a lot of rich information in there. For BIOVIA, we don’t want to replace the capabilities of the LC-MS data analysis software, we want it to continue doing its job. We want to exchange and provide him with any method information, any sample information. But then when the experiment is over, we want to grab the results – let the LC-MS software do what it’s doing right, and we might want the aggregation and the results. We could take that in the form of sample identifiers, aggregate results.

For LC-MS in particular, we have a lot of customers who want to see the traces of the spectra. We can store them as images. If this data remains in the LC-MS system, we have a hyperlink that allows it. We’ll take the sample ID based on the material, and then the results, the identification, whatever sort of specific information LC-MS gives us, and then we’ll hyperlink to that source system.
If this source system does not persist, we will put the raw data, the instrument data, in a secure location that we can hyperlink to for any follow-up investigation.

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