Insights on New Modalities, Digital Integration, and Manufacturing Innovation

In an interview with PharmTech, Andrew Mitchell, associate vice president of Business Development at BioVectra, provides a comprehensive overview of the evolving contract development and manufacturing organization (CDMO) landscape. According to Mitchell, the most significant industry trend that emerged in 2025 was the “boom” of new therapeutic modalities, specifically antibody-drug conjugates (ADCs), RNA, and cell and gene therapies. However, the industry also faced geopolitical turmoil that affected vaccine sentiment and funding cuts that forced small biotech companies to consolidate their pipelines. Despite these challenges, the market saw significant M&A activity.

Digital transformation is increasingly central to manufacturing efficiency. While tools like laboratory information management systems, electronic batch records, and project management software are already established, AI is now emerging in manufacturing and data analysis. A major barrier to AI adoption remains the high cost of proprietary licenses, as companies cannot use public, open-data models for sensitive pharmaceutical work.

The rapid pace of digitalization has created a skills gap, necessitating that staff with traditional chemistry or biology degrees upskill in the IT sector . BioVectra addresses this by collaborating with local universities and training-based companies to provide continuous education, while also using pay and benefits to retain talent.

To improve competitiveness, CDMOs are focused on reducing cycle times to lower costs for clients. Technical innovations include engineering E. coli expression systems for extracellular secretion in microbial fermentation, which reduces capital and operational expenses while avoiding hazardous chemicals. Additionally, the use of flow reactors in chemistry ensures cleaner reactions and fewer impurities.

Looking ahead to 2026, Mitchell predicts continued growth in precision oncology and RNA therapeutics. He highlights the increasing importance of drug delivery systems, specifically the development of new lipids to improve the stability of lipid nanoparticles. Finally, there is a trend toward companies seeking CDMO partners that provide a pathway from early-stage development to commercial production.

About the speaker

Andrew Mitchell is associate vice president of Business Development at BioVectra.

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Hi. My name is Andrew Mitchell. I'm the associate vice president of business development. Business development in BioVectra is the client facing section, the commercial section. And our company is based in Atlantic, Canada. We have four different sites which are using different modalities to manufacture drug substance, primarily drug substance, but also some drug products for the pharmaceutical industry.

Which trends did you see or experience in 2025 that you believe impacted the pharmaceutical industry the most? How and why?

So, I think the biggest trend that we continue to see is the emergence of new therapeutic modalities, specifically at this point in time, ADCs, which are which are really having a boom in the industry, radio ligament therapies, RNA and cell and gene therapies, and also the bio multi specific antibodies as well.

We also see, I mean, it's quite obvious, there's been a lot of geographic political turmoil which has affected particularly the sentiment about vaccines. The industry itself. There have been cuts in funding, which has restricted many smaller biotech pipelines, and generally, there has been a move to consolidate pipelines to maybe one or two maximum in the small biotechs in the clinical trials, which has narrowed the opportunities for people like ourselves in the CDMO field. However, on top of that, there has been a very buoyant pharma acquisition market in 2025 again, continued consolidation in the CDMO field, like ourselves, we were acquired by Agilent in late 2024 and have been going through an integration process in 2025, but there's also been vertical integration by CDMOs, and a noticeable activity by private equity in acquiring CDMO assets as well.

What role do artificial intelligence and digital technologies play in accelerating drug discovery and improving manufacturing efficiency, and what are some unresolved barriers to full adoption?

So, I mean, digital technologies have been moving in for quite some time. I mean, we've got LIMS systems. So, you know, laboratory systems that are that are helping to streamline the progress of samples and testing throughout the system. We now have the use of electronic batch records, which are becoming increasingly more popular in the industry, and also project management software, whether that be monday.com or smart sheets or whichever system that is available to different companies.

And there is now a lot of use starting to emerge of artificial intelligence in manufacturing, analysis of quality data and data in general, but one of the big barriers to this is the cost of the license. You clearly can't use a public data open data AI model. You have to have an AI agent which is specific to your company. And that's a very large cost at the beginning. But it does seem that everybody at the moment is looking at AI in different ways, in terms of manufacturing, and I think that's something that's going to be increasing in the future, and hopefully will bring not just efficiencies, but also productivity as well, into the industry.

How can organizations bridge the widening skills gap created by the rapid digitalization of pharmaceutical manufacturing, and what best practices are emerging for workforce development?

In our industry, it's very common that we have staff with degrees in either chemistry, biology, or engineering or combination of those. But as mentioned in previous discussion,

the use of digitalization is requiring people to also upskill in the IT sector as well, and that works hand in hand with their existing experience. So to do that, we've been working with a number of local universities and also training-based companies to provide our business with the workforce that is trained and efficient to enable us to not only keep talent, but also we have to work to train it constantly and update it, but also incentivize them through pay and other benefits to help them to remain with us.

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

Speaking, specifically from a CDMO point of view, we're all about improving the cycle times of the processes that we operate on behalf of our clients and are continually looking at a process of chipping away to make small improvements.

Improvements, and the many small improvements, add up to a large gain in terms of cycle time reduction for the client, which is always good. They get less time than our client means lower cost, and lower cost basically also means for them, you know, better margins on their drug product, better competitiveness as well. One of the major opportunities we have is in the manufacture of biologics through microbial fermentation. In addition to bringing in technologies which improve the flow in line, sterilizers as one example, we've also been looking at engineering the expression systems, specifically E. coli, so that we can actually perform extra cellular secretion, and this allows us to cut costs in terms of CapEx, OPEX cycle times, and the use of hazardous and not very nice chemicals when doing the repro refolding of proteins. So, we're always looking at this, these types of improvements, I would say, on our chemistry business, and also in our highly potent business, we're looking at the use of flow reactors to ensure that we get cleaner reactions fewer impurities. Are able to handle a much wider range of reactions and basically then adding that and rounding all of those things off with the use of real-time release and analytical technology.

Which trends do you see driving innovation and drug development in 2026? How and why?

We continue to see the growth in the new modalities. I don't think that we will ever believe that small molecules will go away or mammalian products will go away, but we do believe that there is still a lot more to go. In terms of RNA therapeutics, the cell and gene therapies, they seem to be making headway. They have some hiccups along their path, but seem to be moving in the right direction. We see a lot of work being done on precision oncology, and that we're involved very much in the ADC part of that, the payload part, not so many new payloads. Some are still coming through, but a selection of payloads which can be added to new antibodies to for targeting.

One other part that we see is delivery systems, and this is becoming quite important. People realize that perhaps the lipid systems, just the standard lipid nano particle could be improved, and they're doing a lot in that field to try and find new types of lipids which might improve delivery and stability of the drug product to into the body. And finally, we see a slight change in that companies who perhaps are more constrained in their early stage are looking for companies such as ours that have capabilities in both early stage and a pathway to commercial production. And I think these are the trends which are going to be seen and will continue in 2026.