Q&A: Strategies for Supply Chain Resilience and Next-Generation Process Optimization

The biologics sector is strengthening supply chains through strategic demand planning and vendor partnerships, says Sigma Mostafa, PhD, chief scientific officer at KBI Biopharma, in an interview with BioPharm International® during CPHI Frankfurt, held Oct. 28–30, 2025. Manufacturing efficiency is optimized using innovations like membrane technology, N-1 perfusion, and automation, she points out. Meanwhile, AI and digital technologies promise game-changing efficiency, though challenges remain regarding data quality, regulatory guidance, and bridging the widening skills gap.

BioPharm:How is the biologics sector reimagining supply chains to protect against current global issues?

Dr. Mostafa: This is a very important question, and it really comes down to demand planning; essentially, being able to plan as far ahead as possible. It involves building a true partnership with vendors, which KBI Biopharma has been doing. We are proactively improving our supply chain processes and building partnerships with vendors to stay ahead of this challenge. This also includes being able to provide long-term supply chain requirements, as well as looking at different locations the vendors may have for the same product. Being able to access products from locations that are going to be favorable to us is key. While materials cost goes to the client in the case of a contract development and manufacturing organization, we want to make sure we do the best we can, both in terms of cost and in terms of the timeline impact of these supply chain challenges.

Which recent innovations in product development or process optimization have had the broadest impact on cost, quality, or speed-to-market?

Some of the process optimization trends we are seeing are in terms of moving more toward membrane technology for capture. We know Protein A resin is extremely costly, and being able to move from columns to membranes, especially for first-in-human processes, can offer quite a bit of cost savings for smaller companies.

We are also seeing a lot of use of what we call N-1 perfusion. This involves getting to higher cell density in the seed reactor and being able to run the production reactor for a shorter period. This way, you can potentially reduce the production process from 14 or 16 days to perhaps half the time, which impacts how many batches you can run in manufacturing.

In addition, all the automations and high-throughput technologies that continue to come into the biomanufacturing sector are having a significant impact. This impact is both in terms of being able to do experiments faster, but also in terms of batch release and batch validation.

What role do AI and digital technologies play in improving manufacturing efficiency?

In terms of manufacturing efficiency, being able to track the manufacturing batches, track all the analytical data from those batches, and being able to predict what is going to happen with the batch through digital twins and various other technologies are game changers. That is where we see efficiency gains. For commercial batches, this is where we can improve the success rate.

We also see some challenges. Being able to bring in AI and digital technology in the good manufacturing practice realm, in a regulatory setting, can be challenging. Creating guidance and precedence is receiving a lot of focus now.

What we also see challenges on is the data quality and the data formats. A lot of companies have spent a significant amount of money to build their own systems for digital transformation, often with mixed success. It is important to build small successes and demonstrate to the organization that this can create efficiency. It is also crucial to understand how the data structure will work out so that historical data can be taken advantage of when implementing AI into manufacturing.

One advantage, of course, is being able to look at current runs. But if you can look at historical data and put your current batch in perspective against that, that is significantly more powerful, and that’s where much more data crunching and having the proper format of data is needed.

How can organizations bridge the widening skills gap that is created by the rapid digitalization of biomanufacturing?

This skills gap is a real challenge, and the trainings are also not very well defined. Obviously, training and retraining of our employees is going to be needed.

What will also be needed is to find a segment of the employee population who wants to become experts and who can be the champions within the organizations. This is needed rather than having a separate AI training group (which may be needed as well). Having embedded technical folks who are also very savvy in digital solutions is what is needed to overall bring up the skill set of the organization.

What best practices for digitalized biomanufacturing are emerging for workforce development?

We are seeing very good programs being created in a lot of universities that have biomanufacturing master’s programs, where trainings are being given. These trainings cover not just hands-on manufacturing, but also a lot of these digitalization tools. We also see that [many] of the larger tech companies are getting into the health sector, and they are creating many training opportunities. There are certainly a lot of training options available online. Some of it has to be self-training for people, but each company now has a responsibility to upskill the training of their staff.

Click the following link for a related video interview with Dr. Mostafa. To catch up on all of our conference coverage, please click here.

About the speaker

Sigma Mostafa, PhD, Chief Scientific Officer, KBI Biopharma

Dr. Mostafa oversees analytical services, process development, and cell line development at KBI Biopharma. Over her 13-year tenure, she has driven the company’s rapid growth, building KBI’s North Carolina operations into a world-class contract development and manufacturing organization with advanced automation and scaling its development programs tenfold. Previously, she served as senior vice-president and site head, leading KBI’s largest site through unprecedented expansion and a successful FDA pre-licensure inspection.