Drug Digest: Speed, Flexibility Top Large-Molecule Manufacturing Trends

In this exclusive Drug Digest video interview, Patrick Lavery, Editor, Pharmaceutical Technology® Group, interviews industry experts about large-molecule manufacturing trends. During the discussion, the experts will detail what those trends are, what are currently some approaches to speeding up development timelines without sacrificing quality, how manufacturers are strategizing to accelerate the earliest stages of development, and what the future holds in terms of next-gen advancements.

Interview featuring

Deepak Bahl, Global Head of Applied Sciences, Pharma, Roquette

Deepak Bahl currently serves as Global Head of Applied Sciences, Pharma, at Roquette. His experience spans the development of conventional and enabled dosage forms of small molecules, liquids, parenterals, and peptides. He has held positions of increased responsibilities at Bristol Myers Squibb, Celgene, Merck and Co., Catalent Pharma Solutions, and Ranbaxy Research Laboratories.

Deepak has a PhD in Pharmaceutical Sciences from the University of Connecticut and Masters in Pharmacy (MPharm) from the College of Pharmacy, New Delhi. His work has led to the approval of four NDAs & MAAs, five ANDAs, three 505(B)(2)s, one BLA, and several patents/publications. His expertise includes design and scale-up of complex formulations such as gastroretentive systems, controlled release, multilayer tablets including bilayer and trilayer tablets, Zydis orally disintegrating tablets, multi-unit dosage units, and reverse engineering for development of generic bioequivalent pharmaceutical products. Deepak has held several leadership positions at the American Association of Pharmaceutical Scientists and currently serves as the chair of the AAPS Preformulation & Formulation Design/Development Community.

Jagruti Patel, Senior Director of Commercial Development, Lonza

Jagruti Patel is a senior professional with decades of experience in the biopharmaceutical industry and at Lonza. She plays a pivotal role in bridging operations and commercial teams to drive innovative biologics partnerships. Starting her career at Lonza in Slough as an entry-level R&D scientist, Jagruti has held diverse roles across the global network, including program management, key member of site leadership team, and commercial strategy in locations such as Singapore, Portsmouth, and California. Known for her collaborative leadership and strategic insight, she has been instrumental in shaping customer-centric solutions and fostering a culture of appreciation and growth. Jagruti’s journey at Lonza is not only a testament to her professional achievements but also to the strong community and lifelong relationships she has built along the way.

Sponsors

This episode of Drug Digest is sponsored by:

• Eppendorf
• Eurofins
• Kindeva
• Veltek Associates

About Drug Digest

Drug Digest is a tech talk video series with the Pharmaceutical Technology® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Upcoming episodes

• September 2025: Developments in Small Molecule APIs, Excipients, and Ingredients
• October 2025: Partnering for BioPharma Success
• November 2025: Updates in Quality Regulations

Transcript

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

Patrick Lavery

Pharmaceutical Technology presents Drug Digest, a tech talk with the Pharmaceutical Technology editors, all about emerging opportunities, obstacles, and advances in the pharmaceutical, biopharmaceutical, and biotech industries. Join us as we discuss with industry experts, the research, development formulation analysis, upstream and downstream processing, manufacturing, supply chain and packaging, as well as business strategies and regulatory issues.

I'm Patrick Lavery, editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and Biopharm International. For this episode of the Drug Digest Video series, I will be discussing the topic of large molecule manufacturing trends with Deepak Bahl at Roquette and Jagruti Patel at Lonza. In our chat, Deepak, Jagruti and I will look at strategies for accelerating early stage development in the large molecule sector, while reducing risk approaches to speeding up timelines for complex formats, particularly for investigational new drug designations without sacrificing quality, maintaining a flexible chemistry, manufacturing, and controls process that ensures quality and looking ahead to the next big thing in large molecule manufacturing.

This episode of the Drug Digest is sponsored by Eppendorf, Eurofins, Kindeva, and Veltek Associates.

Eppendorf: let's bioprocess together. Eppendorf aims to support you with your specific challenges, whether you are developing cell and gene therapies, antibodies, vaccines, modern food, or other products. Eppendorf provides scalable bioprocess systems and encompassing software solutions, all orchestrated to optimize process control, automate tasks, and harness the power of data.

Eurofins CDMO Alphora is a Canadian contract drug development and manufacturing organization, which delivers fully integrated process development and GMP manufacturing solutions for small molecule APIs, drug products and biologics, including mAbs and ADCs. Enhanced by the scientific depth and geographic reach of the global Eurofins network of companies, Alphora provides seamless access to advanced analytical services supporting biopharmaceutical companies from early development to commercialization.

This episode is also sponsored by Kindeva. Kindeva: Manufacturing more Tomorrows.

And Veltek Associates is a single source supplier providing solutions for pharmaceutical or biotechnology contamination control requirements.

Without further ado, let's jump into today's discussion. My thanks to Deepak and Jagruti for joining us to talk about large molecule manufacturing trends.

Firstly, can you please introduce yourselves and give our audience some background on your roles and industry expertise?

Deepak Bahl

My name is Deepak Bahl. I'm the global head at Roquette Pharma Solutions. I have a PhD in pharmaceutics from University of Connecticut and throughout I've worked in different pharmaceutical companies, Ranbaxy, Catalent. Schering-Plough, Merck, Celgene, Bristol Myers Squibb, and now Roquette. I lead a team here which looks into the global product development on excipient side, both for biologics as well as small molecules.

Jagruti Patel

So a bit about myself. I'm based in the UK. I started my career at Lonza 20 years ago. I started as a scientist and, startE managing, teams in the science area.

As a line manager, I moved into program management and looked after. vast amount of Lonza customers and their timelines and their programs all the way from clinical to commercial. And then I moved abroad with Lonza and some of the facilities that we have across east Coast, west Coast, and also Singapore, as program management in leadership roles.

And then I came back to the UK to start my career in commercial development. So currently I am in the integrated biologics business platform and I look after Small scale mammalian network across the globe. So we have assets in the UK, We have them in the East Coast, Portsmouth, and Singapore and Switzerland.

Patrick Lavery

Can we launch into this topic by having you both give us a high level overview of the current trends in large molecule manufacturing?

Deepak Bahl

So the pharma industry and biopharma especially, is really going through a transformative trends and the biopharma industry is projected to boom in the next decade or so, there are a lot of things that are happening in the biopharma industry.

a lot of companies are focusing and actually moving from small molecules, trying to focus on high margin biopharmaceuticals, especially because the sales, even though small molecules currently is having a higher, projected number, but biopharma is increasing, so the sales is expected to grow.

Also in biopharma, it's a higher margin, higher return on investment business. a lot of small molecules are going through patent expiry. So essentially this biopharma provides companies a lot of platform, to go into that area, to really, augment their pipelines with within your patterns.

also. the biopharma industry is, partnering with a lot of upcoming biotechs. That's a recent trend that we are seeing. there's a growth in the major clinical, areas, especially oncology, which is projected to be about $440 billion market over next, five to 10 years. There's also companies growing into diabetes and weight loss therapies, GLP-1s, and in that category of products. Also beyond GLP, they're also looking into expanding their GLP into different disease areas, cardiovascular areas, for example. They're also looking into chronic kidney diseases, as well as sleep apnea.

The other trends that we are seeing so far is about continuous manufacturing. So continuous manufacturing is really improving the efficiency of the process. And actually it can do a real time scale up adjustments for pharma industry, if they're seeing. they need a higher supply chain volumes, they can dial in and similarly they can dial out. So that's really, we'll see that will be, upcoming and growing a lot more along with these sides.

We are also seeing a lot of patents, which are going to expire in next decade or so, especially it is projected that about 70% of the revenue from the top, selling 10 to 15 drugs will go down in next five to six years. So the companies are looking to augment this by, really accelerating their internal growth engines as well as it through mergers and acquisitions and the lifecycle managements, of their current products. especially trying to convert the parental drug products to the oral drug delivery systems.

Beyond that, we are also seeing a lot of, evolving regulatory trends. The regulatory agencies are becoming tighter and tighter with respect to different, excipients and the regulations. one of the recent example is the, banning of, surfactant called Triton X. Similarly, they're looking into, nitrosamine.

So it started with small molecules and now it's extended to large molecules, biologics, in terms of nitrosamines. then we also see, we also envision that this trend will continue and the agencies will expand this beyond one or two examples that I'm providing, and then we'll look into future excipients and opportunities to create more safer drug products for human consumption.

Jagruti Patel

I think I'll start by saying that the demand for complex biologics and next generation therapies continues to rise, and we've got emerging biotech companies really driving innovation for therapies in areas like oncology, autoimmune disease, diabetes.

But I think most notably the trends that I've seen in large molecule manufacturing are around changes in the biologics pipeline and growing now into new molecular formats. So previously we would see biotech pipelines with, standard and, monoclonal antibodies. And now we're seeing a lot of those pipelines changing into really complex molecules, bispecifics, so quite varied now.

In addition to that, in the drug product side. We're also seeing an expansion driven by patient-centric dosage forms like prefilled syringes and cartridges, along with trends also for higher concentration final formulations. So all of this packaged nicely is a really varied flow of molecules entering the clinical space and in addition, I think other trends that I've also seen are an increase in industry outsourcing. So in 2024, we saw the CDMO share at around 49%, and that is expected to increase to around 56% by 2029.

So as you see the CDMO share increasing, we also see a trend in accelerating strategic partnerships between us CDMOs and our customers. In addition to that, we're also seeing customers asking for more integrated solutions, and that to me is a no-brainer when you're looking for simplified logistics, accelerated timelines, harmonized technologies.

And just to finalize on the commercial trends that I'm seeing is that connected to that, we're also seeing an increase in demand for on and nearshoring manufacturing. So again, not only does it provide the customer leaner management and logistics, but it also means that they're exposed. They have minimal exposure to geopolitical shifts that they're seeing today. I would then say, I think to finalize on the biggest trend that we're seeing in large molecule manufacturing today is how AI can support the growing demand to develop therapies faster and more efficiently.

There's a real need now for capturing high quality, informative data on top of reducing cost and timelines. So just to give some examples of what Lonza is doing in this space, is that we work with predictive models to support tech transfers and market modeling. We use data governance frameworks. We have a system called simcar, which allows for real time process modeling.

It uses a multi-variate data analysis, almost like a form of machine learning to monitor processes and detect anomalies like before they become problems. Similar to that, we also use, Raman technology in our processing. And what that does is that it estimates glucose in near real time to enable control and reduce variability across batches manufacturing batches.

So to summarize, the key trends in large molecule manufacturing in my experience, are changes in molecule formats and their delivery, and increased need for integrated solutions. A greater need for strategic CDMO partnerships. And the use of AI in process robustness, real-time data and modeling.

Patrick Lavery

What are some strategies for accelerating early phase development while reducing risk?

Jagruti Patel

Yeah, this, definitely is a common challenge we see, and a lot of our customers ask this very question, right? Because what they're trying to do is select the best candidate to take into development and limit the rework and improve efficiencies, and getting to get to the first in human studies as quickly as possible.

So I would say some of the strategies that I would recommend is working with a partner that can really identify those risks early, making sure contingency plans are in place for those risks and flexible scheduling to allow for any rapid changes to that work plan. And that really is key now. I think on top of all of that, you absolutely need to know your molecule.

You need to know, you need to be doing some early screening to identify those risks. And in this space, Lonza does, really great work in offering packages for early risk, detection. So we offer immunosafety assessments with in-vitro and in-silico testing, manufacturability assessments, and early formulation screening.All of this can really help ensure that the work scope is targeted, efficient and as lean as possible.

Deepak Bahl

Artificial intelligence is growing its dominance in every industry, and pharma and biopharma is not sparing there either. the biopharma, and the industry can especially benefit from, the early stage development because artificial intelligence can really scan a large piece of information in a relatively short time, and then help to predict based on structures and other informations that it's looking into how, what is the next logical step that one needs to do?

Along with artificial intelligence, I would say, high throughput screening is the another one where once the prediction of the theoretical prediction of the molecule is done, marrying high throughput screening, robotics with automation and miniaturization, can really help to do those experiments very quickly, to identify hits and leads, which can really accelerate the early stage development.

these are the early discovery, areas where, how one can accelerate an early stage development. along with that, there's advancements in the cell lines and modeling techniques. So these, advanced cell lines and modeling techniques, can provide a realistic and relevant models of human biology, and that really helps to, foster and augment a faster, early stage development.

In parallel, I would say the clinical stage, the adaptive clinical trials, one would see more and more adaptive clinical trial designs coming up. This is very important because in olden days, once a clinical protocol is written, there is no ability to change that, until the later stage of the end of the trial and then modifying it.

But now what these adaptive clinical trial designs provide is, they provide a flexibility and resource optimization as the data is getting, collecting, during the same period, one can evolve and change the clinical trial design, yet maintaining the integrity of the design. So that is very important and cost saving, initiative for the companies.

We are also seeing, the other things that would, could accelerate is the expedited regulatory approvals, especially in the areas of unmet medical needs. And so things like, fast track approvals can really help to bring, products to the market sooner. Along with that, collaborations with CROs and CDMOs is very important.

the clinical, the clinical testing and data collection can be accelerated. By using CROs, which are dedicated companies just doing day in, day out, just clinical work. And similarly for the CMC aspects. Now the CDMOs, which do manufacturing scale up, early screening, they can do a lot of work, and help big pharma, in accelerating their drug product development.

Working closely with excipients is another area which can help accelerate early stage development, especially because some of the excipient manufacturers have the specialized know-how and they can also, tailor the excipients to the unique functionality needs for a drug product sponsor. And finally I would say, one of the strategies that companies are using to accelerate the early state development is augmenting their in-house pipeline by mergers and acquisitions.

They're going through startups and, smaller biotechs and trying to acquire them if they see some proof of concept that helps them to really. Give a jumpstart for their drug part regarding some of the more complex formats that have emerged in recent years.

Patrick Lavery

Can you describe approaches to speeding up timelines, whether for investigational new drug designations or otherwise without sacrificing quality?

Jagruti Patel

I think some of this, was answered in the previous question with the early screening. And as I said, that's really key to know your molecule, making sure that your work scope, your timelines, and really develop to make sure you have those real, Go, no go decisions and you've gathered all the data that you need to move forward with.

On top of that, I think high throughput analytics is really key. Making sure that you can test as much, as many samples as possible as quickly as possible. having a robust platform technology with significant data behind it to enable leveraging from one molecule to another and making sure that the data that's behind it can show help you and show you what you need to do and maybe not even need to do it, using, or getting to talk studies quicker.

So again, Lonza has seen a real need for that. And what we've developed is a timeline to use stable pool cell lines to deliver tox material to get to your tox studies quicker, two and a half months faster than our standard timeline. The last thing I would say is having an end-to-end offer to harmonize your drug substance and drug product methods, your quality systems and the tools that you're using every day can really help speed up your timelines.

Deepak Bahl

Obviously, the things, that I mentioned, there are rooms to augment and optimize these, strategies. For example. CAR-T, which is for the, oncology, area. there are, the traditional CAR-T is, called Autologous CAR-T. What happens there is, a patient's T-cells are engineered so that they can fight against and they're put back into the body so that they can fight against the cancer cells.

So the way that works is, essentially a patient's blood is, withdrawn. T cells are isolated from there, and then they're frozen. And then they go to the manufacturing facility where they are again, thawed, and then they're genetically engineered. and then quality control tested. and then the product is again, frozen and it goes back to the, to the patient where it is, administered.

And then the body does the rest of the trick where it starts fighting against the cancer cells. So when the CAR-T came into existence, couple of years ago, it used to take more than 40 days, and then the company started, more and more optimizing and now. I think it is reduced about half a time or maybe 18 days or something, but it is still not, fast as well as cost effective.

So what companies are researching now is, something called Allogenic CAR-T, which is a generic version of CAR-T off the shelf. So essentially they will take T cells from healthy volunteers and then genetically modified to certain disease, indications, receptor bindings, and then essentially those, allogenic CAR-Ts can be given to the patients quickly. and that is, an excellent way to, to reduce the cycle time as well as, improve the efficiency of the process. So we'll see more and more, like things like that. also I would say partnering with the experienced excipient providers.

That's another area because they're experts and help in the commercial scale up. Especially also helping the pharma companies, biotech companies to meet their complex supply chain demands. So those are the few areas that come into my mind, to really help, for these complex formats.

Patrick Lavery

Can you explain the importance and maybe offer some strategies for maintaining a CMC process that remains flexible, but also ensures product quality simultaneously?

Deepak Bahl

CMC, the chemistry, manufacturing and controls plays a very vital role in intra product development. So the three pillars of any drug product that comes to market, whether it's a biopharma or a small molecule, it's a safety, efficacy and robustness. So the safety. and the efficacy is more, demonstrated through clinical trials, the human clinical trials and then before clinical trials, the preclinical animal species trials.

And then comes the robustness, which is the day in, day out manufacturing of the drug product and ensuring. That the quality control is maintained, ensuring that all the quality attributes of the drug product are maintained within the specifications. CMC plays a very important role in ensuring that whatever is promised with the agency in terms of maintaining a safe and a robust drug product is within control. So essentially the, it is very vital. and also CMC helps to get the regulatory approvals for the drug product. before that you can excel as in most cases. So it's very important function and absolutely critical function.

Jagruti Patel

in my view, I think I can't stress enough. Is really key is working with a CDMO who has a proven track record in this space, and they can provide you the scientific experts to work closely with you on the CMC journey. So the scientific experts could design or develop a really tailored tech transfer package strategy.

They can establish a design space for process parameters to allow for the flexibility. And establishing risk management tools like, FMEAs to determine flexibility and really pinpointing your critical quality attributes. At the same time, I'd also say using platform approaches have really can support this and in the flexibility to reduce revalidation, and you're not, again, reduces timeline cost, but also provides the flexibility.

Or you could use a modular system where if you make modifications, you don't have to go back to the beginning and start everything again from scratch. You just have to repeat that one module. Another thing I'd say is, robust regulatory strategies. If, for example, you decided to scale up your process, then having a plan in place on how to handle the post-approval changes is going to be really key.

And lastly, what I'd say is making sure that you have a really collaborative cross-functional team, including representatives from quality and regulatory because they are the ones who are gonna be able to support real flexibility with compliance and quality.

Patrick Lavery

Any other thoughts, perhaps a look into the future at the next big thing?

Jagruti Patel

I think the main thing I would say is the thing that I've repeated on the last question is picking that CDMO, that can identify your risks really early on. And when you do travel along that journey, that seems to journey, you're moving through your phases and you are, you're going into late phase.

It's making sure that, that CDMO has, the track record is proven in this space and is able to time and time again deliver on what you are asking.

Deepak Bahl

It's very exciting times. I won't say one, but there are a couple of things that I could see, that could Turn into a next big thing in the biopharma area.

Obviously, AI is there. CAR-T as I mentioned, some of the things that I'm already mentioning, but essentially the precision and personalized medicines, the mRNAs and techniques like genetic profiling and biomarker research. They all really will play a big role to, to have the precision and personalized medicines of the future.

As an excipient manufacturer, it's pretty exciting for Roquette, to be a leader, in the biopharma area. And then we are excited about the oral biologics as you see. What we see, the trend is, a lot of, the weight loss area, drug product manufacturers transforming their products from parental delivery to oral, solid dosage forms. So that's an area that we could think of, which is really exciting in the upcoming future.

Also, we look into development of novel excipients, which would be more advanced, and safer, especially in the areas. For example, I can give you an example of a permeation enhancer because that will help to really take the, products which are not readily absorbed from the intestine, to help them absorb from there into and going into the bloodstream. there are not many permeation, hand enhancers in the market at the moment. From a manufacturing CMC robustness perspective, I could see modular manufacturing suites and, disposable single use manufacturing equipments upcoming more and more. And then, manufacturers will offer that, in the upcoming years or so.

Patrick Lavery

Deepak and Jagruti, thank you so much for taking the time to talk with us. It's been wonderful. I hope you've enjoyed this discussion on large molecule manufacturing trends. If you would like to learn more about the topics discussed in this Drug Digest episode and others related to the biopharmaceutical industry, please visit our websites at pharmtech.com and biopharminternational.com.

Thank you to our sponsors, Eppendorf, Eurofins, Kindeva, and Veltek Associates for sponsoring this episode, and thanks again to our expert speakers for sharing their insights. Tune into the next episode of the Drug Digest series in September, focusing on developments in small molecule APIs, excipients, and ingredients.

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