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The PharmTech Group spoke with BIOVECTRA's director of Business Development, Nucleic Acid Modalities, Jessica Madigan

Flexibility in Outsourcing Models

Outsourcing pharmaceutical manufacturing and development processes can provide pharmaceutical companies with financial flexibility, according to Jessica Madigan, director of Business Development, Nucleic Acid Modalities, at BIOVECTRA. The PharmTech Group spoke with Madigan after the BIO International 2024 Convention to learn more about the flexibility outsourcing models can provide.

“At BIOVECTRA, we offer flexible pricing models that can help companies manage cash flow and financial risks,” said Madigan. “[Pharmaceutical companies can reduce] capital investments by leveraging the infrastructure and specialized equipment that is already onboarded at CDMOs [contract development and manufacturing organizations]. This can be especially important for startups and small biotechs. … it allows them to direct the resources to their other business areas, rather than building up infrastructure and investing in specialized equipment.”

Madigan details the five different models her company provides, including a dedicated facility model what includes an entire building or facility reserved for the customer. Fractional ownership of a facilities with other customers is also available. “That way, we can [leverage] essentially a platform manufacturing process or a similar platform manufacturing process across several clients, that offers flexibility of capacity between those different partners, and allows a lower entry into a larger capacity.”

Click on the video above to watch the full interview. BIO 2024 occurred on June 3–6 in San Diego, Calif.

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The PharmTech Group spoke with BIOVECTRA's director of Business Development, Nucleic Acid Modalities, Jessica Madigan, about the concept of flexibility in outsourcing and the 2024 BIO Convention.

 Flexibility in Outsourcing Models (BIO 2024)

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

The Need for Automated and Standardized CGT Manufacturing (BIO 2024)

While cell and gene therapy (CGT) manufacturing must remain flexible out of necessity, it is also important to standardize processes at an industry level while establishing aseptic-friendly automated operations. Standardization, in particular, is important from a scaling perspective, says Joe Garrity, senior director and head of Autologous Cell Therapy, Lonza.

During BIO 2024, Garrity pointed out the many challenges incurred on the cell therapy side. “It stems from supply chain to operations to clinical sites. There's just so much that needs to go into, specifically, autologous cell therapies, with the batch quantities going into the hundreds and thousands that we're seeing from some of [the] large drug developers.” Thus, he says, standardizing the manufacturing process allows for robustness and process control across the board.

Garrity also notes, however, that even with standardization, “it's not a one size fits all”. Instead, he says, “[much of the time,] it's a little bit of a one size fits most, and you're going to have to be relatively variable, but in the end, the overall standardization of the manufacturing process and the intent of that remains the same because it's better control at scale. Once you find something that really funnels that process robustness and that scalability, you … stick with it so it's reproducible time and time again.”

In discussing whether it’s possible to have manufacturing processes that are both standardized and flexible, Jerry Jiang, clinical application specialist, Personalized Medicine, Cell and Gene Therapy, Lonza, says, “Definitely. One of the things that we really have to start standardizing is the release criteria and the quality of the cells that are being put into the patients. [The] material that comes in is going to be different, but standardizing what we expect the cells to do and behave and what they look like is going to be a huge part of what the standardization process needs to overcome right now.” However, flexibility remains in the details. “[T]he standardization is the same, but the flexibility of the process allows these different companies to optimize the process with their ‘secret sauce’ that will really differentiate their treatment from all the other treatments out there,” says Jiang.

“We definitely need to standardize the way we are inspecting and checking the cells before it goes into a patient, but the flexibility allows each company to … show off their technology and allow for them to shine with the advancements that they've made,” Jiang adds.

Click above to view the full interview. BIO 2024 occurred on June 3–6 in San Diego, Calif.

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Lonza’s Joe Garrity and Jerry Jiang discuss the latest trends and challenges in commercializing new CGTs. 

Trends and Obstacles in the CGT Field (BIO 2024)

Cell and gene therapies (CGTs) remain an important focus in the biopharma industry. During BIO 2024, Joe Garrity, senior director and head of Autologous Cell Therapy, and Jerry Jiang, clinical application specialist, Personalized Medicine, Cell and Gene Therapy, both at Lonza, discuss the latest trends and hurdles in the CGT space.

“Moving from the 2017 timeframe into 2020, we saw a heavy focus on a [significant amount of] money floating around focusing on autologous cell therapies and how we can better provide these life changing therapies to patients,” Garrity says. From the autologous cell therapy perspective, efficacy has been achieved, but the challenge remains that an autologous cell therapy is one manufacturing batch, or one dose, per patient. “The scaling is a little bit of a challenge,” Garrity says, noting, “This is where the allogeneic approach has taken over, and in the cell therapy space, we've really seen that shift … seen [focus] go from two-thirds autologous to one-third allogeneic to almost a 50/50 split.”

Garrity expects this trend to continue to where the industry may see a rise in allogeneic cell therapies, from a molecule number standpoint. “We're seeing a [bigger] influx of allogeneic cell therapies trying to provide a secondary option to commercially viable CAR-T [chimeric antigen receptor T cell]/CAR-NK [chimeric antigen receptor natural killer cell] drug products,” he states.

“At the end of the day it’s really about providing access and availability of cell therapies to those who really need it,” Jiang adds. “The cell therapy production process can be complex, and current solutions are not sufficient to be able to scale to the patient demand. So, as a result, new technologies are being developed to help reduce timelines and cost and improve scalability.”

Another issue Jiang points out is the difficulty in finding technicians who are able to work with and produce these therapies. “We've seen [many] different manufacturers try to figure out different ways of scaling down … either making the process faster or taking out other aspects of their manufacturing process to really streamline this process, as well as just reducing the costs [of these] therapies.”

Click the video above for the full interview. BIO 2024 occurred on June 3–6 in San Diego, Calif.

Lars Petersen, CEO, FUJIFILM Diosynth Biotechnologies discusses the company’s strategic goals and meeting market demand for mammalian cell culture capacity.

Demand Remains Strong for Mammalian Cell Culture Capacity (BIO 2024)

Demand for mammalian cell culture capacity remains strong and is growing, notes Lars Petersen, CEO of FUJIFILM Diosynth Biotechnologies, during BIO 2024. The company’s main strategic goals for this year centers around meeting this demand. “We are starting up a facility right now in Denmark (1), which is maybe the highest priority,” Petersen says, who also emphasizes that the company has “multiple CAPEX [capital expenditures] projects that we need to finish up.”

“In general, we are we shifting the business after COVID, after some of the financial challenges, to [focus on] what demand is most important … and we see a lot of new interest coming in. Being ready for that [demand] … is the most significant goal of the year,” Petersen says.

As for the company’s expansion of its Holly Springs, N.C., mammalian cell culture facility (2), Petersen explains that this expansion “has really been driven by demand … Demand is high.”

The market for mammalian cell culture needs more capacity, according to Petersen. “There's so much volatility shift and demand from new products coming in, shifting the market from innovators to CDMOs [contract development and manufacturing organizations] [for] new modalities [in treating diseases] like Alzheimer's. The pressure is on [for] other modalities that all end up with higher demand,” he says.

In terms of the future of therapeutic modalities, Petersen sees antibody drug conjugates making a comeback after about a decade and, conversely, a bit of slowdown in messenger RNA. “All these modalities, they really are difficult to foresee,” he observes. However, he expects that monoclonal antibodies will remain a major therapeutic modality for potentially the next 10–15 years, at least.

Click the video above for the full interview. BIO 2024 is being held in San Diego, Calif., on June 3–6.

1. FUJIFILM Diosynth Biotechnologies. FUJIFILM Diosynth Biotechnologies Breaks Ground For Major Expansion of Its Large Scale Biologics Production Facility in Denmark. Press Release, March 3, 2021.
2. FUJIFILM. FUJIFILM to Invest Additional $1.2 Billion to Expand its Large-Scale Cell Culture CDMO Business in North Carolina. Press Release, April 11, 2024.

Lars Petersen, CEO, FUJIFILM Diosynth Biotechnologies discusses the company’s strategic goals and meeting market demand for mammalian cell culture capacity. 

Founder and CEO of Atomic AI, Raphael Townshend, explores AI’s usefulness as a tool to characterize molecular structure and advance molecule engineering.

Applying AI to Molecular Structure (BIO 2024)

Raphael Townshend, founder and CEO of Atomic AI, a US-based emerging biotechnology company specializing in applying the fusion of artificial intelligence (AI) and structural biology for RNA-based drug discovery, discusses the use of AI as a tool for characterizing molecular structure and, in doing so, advance molecule engineering.

“At a high level, why we care about molecular structure is because the structures of molecules really determine what they do: structure determines function, so to speak. What we found in the last few years is that AI is a very powerful tool for understanding the structures of these molecules,” Townshend says. He notes that, traditionally, methods for understanding structure have names, such as X-ray crystallography, or nuclear magnetic resonance, or cryo-electron microscopy. “The issue is that they can oftentimes be very expensive to use and slow to use; it's a very bespoke process. Every single structure that is solved can be a very manual and involved undertaking. And what we've seen is that we can take all this work that's been performed in the field of structural biology, of understanding structures, and feed that into these AI algorithms that are now able to predict those structures in minutes or seconds instead. We've seen these orders of magnitude speed up our ability to model these structures and understand what they look like in their native environments,” he explains, emphasizing that AI enables a “rational drug design”.

“We're already starting to see that and bear fruit today. The use of [AI] … speed[s] up the process of … the whole drug discovery space, of doing the whole drug discovery process, so to speak,” he observes. He further explains that, as an additional layer on top of the traditional drug discovery process, AI can enable rapid screening, or a rapid search, through many possible drug candidates. “[T]he idea is that we're using these kinds of approaches to get to better, faster drugs, and getting things faster to the clinic and running those through a better rate.”

“As I like to say, AI is a cool thing of the day. It's a powerful tool, but it's a tool nonetheless,” Townshend adds. “It's not going to be a panacea; it's not going to solve every single problem under the sun. In particular, the areas where AI works well are those where there's [a significant amount of] data associated with it … and, so, in areas where that data [are] more limited … that can be an obstacle to the development of the correct AI applications in this space,” he notes when discussing some of the hurdles in implementing AI in the drug discovery space. Townshend says that, to address these limitations, the industry would need to collect additional datasets to push progress forward.

“Some areas to really think about, for example, are 

 studies where the amount of animal data that we might have might be relatively limited as compared to high throughput screening stages where you have [much] data, comparatively speaking. [T]hese are resolvable obstacles, but, today, the amount of data out there does not allow for the use of AI in its most advanced form across the entire drug discovery landscape. And that's not even speaking about the development cycle, [such as] clinical trials. There's even more complexity and even more limitations interpret the data. So, while there was this dream of one day using AI across the entire process, right now, there are some key areas where it's providing significant leverage, and we're working towards shoring up those additional gaps,” Townshend says.

View the video above for the full interview with Townshend. Townshend spoke at the 

New Tools, New Times: Chemical and Structural AI for Drug Discovery

 panel at BIO 2024 in San Diego, Calif., which is being held June 3–6.

Andrew Carnegie of Inaphaea BioLabs discusses the establishment of translational CROs and the role of PDCs in the drug discovery process.

A Look at Translational CROs and PDC Modeling (BIO 2024)

At this year’s BIO annual meeting, drug discovery and early phase analytics garner greater industry focus. Andrew Carnegie, PhD, head of Strategic Commercial Development, Inaphaea BioLabs, discussed some trends in the R&D analytical space and the advances being made to speed up the drug discovery process.

Carnegie explains that translational contract research organizations (CROs) aim to bring more clinically relevant humanized cell-based assays to the forefront early in the drug development pathway. Having clinically relevant data early on can help minimize the risk of failure of a compound/molecule in the preclinical and clinical stages of development, he notes.

“[A translational CRO] is really about providing design, input, and interpretation of results, in addition to just running the experiments, and sending a report based on the study,” Carnegie says. “We feel that better experimental design should lead to a more streamlined plan that is more efficient, and it provides our partners with better value for money. So, we're really looking at cutting down timelines and bringing more data points early on in the experiment so people can make decisions about their molecules early on, and hopefully be more successful in the preclinical and clinical stages.”

Carnegie also emphasizes that drug discovery is a challenging process with a low success rate of release of drugs. “Data suggests that poor prediction of efficacy remains the main cause of attrition and clinical failure. Around that, too, traditional drug discoveries relied on 2D cell cultures, often using non-human species, but animal disease models rarely reflect and represent the real causes, complexities, and phenotypes of human disease. This has really influenced a rise of 3D organoids and more clinically relevant, complex humanized cell models in paving the way for more accurate preclinical models that closely mirror human physiology and pathology,” he explains.

Thus, the humanization of the early phases of drug target validation has the potential to significantly improve how targets are validated for drug discovery, Carnegie adds. Among the tools now being used to humanize early phases of drug target validation are patient-derived cell (PDC) models. “The PDC is a primary cell culture, and it's established from the patient cancer cells, which were isolated directly from the tumor tissue or the patient body fluids. PDCs are maintained at a low-pass ID number, and result in a much higher clinical relevance than tumor cell lines. This really ties in with us wanting to bring humanized models earlier into the process to be more relevant and give more relevant clinical prediction and predictive data. The models are a great combination of accessibility and disease relevance,” he states.

Better early analytical work ultimately improves campaign success or the drug development process, Carnegie also emphasizes. “Our approach is to provide improved data by using more relevant 3D and hypoxia testing in disease-relevant systems, and bringing that [in] earlier … allows for more successful campaigns. [In addition], the kill-the-compound early approach is also very valid, allowing time and money to be better placed. So, with that early analytical R&D work, you can really get a [significant amount] of information upfront, [which] makes your decision easier on whether you'll take that molecule into preclinical and then into the clinic,” he remarks.

“PDCs are really the first step towards the true humanization of preclinical science and can be used to improve the translation of preclinical assets and enhance biological understanding,” Carnegie concludes.

Andrew Carnegie, head of Strategic Commercial Development at Inaphaea BioLabs, discusses the establishment of translational CROs and the role of PDC models in the drug discovery process.

The PharmTech Group sat down with Himanshu Gadgil, CEO of Enzene 

Continuous Manufacturing and Cost of Goods (BIO 2024)

Continuous manufacture of biopharmaceuticals is a hot topic in the industry. According to Himanshu Gadgil, CEO of Enzene Biosciences, continuous manufacturing has an impact on a company’s cost of goods. “For example, in a 1500-square-foot cleanroom, we can manufacture in a month currently around 10 kilograms of mAbs [monoclonal antibodies], and we are enhancing that platform where we should be able to manufacture on 40 kilograms of mAbs,” Gadgil says. Therefore, he explains, if a company wanted the same productivity at the moment, they would need a huge plant.

This is where continuous manufacturing is truly beneficial, Gadgil continues. “So, one of the biggest advantages of continuous manufacturing is cost of goods, because the operational cost is much lower than the conventional manufacturing, [because] the footprint is more compact, and at the same time, the productivity is also very high,” he says. “Because when you do perfusion, you get significantly higher cell densities almost five to 10 times higher cell densities than the conventional fed batch.”

When building a new continuous manufacturing facility, unit operations should be connected so that the process flows continuously, remarks Gadgil. “So, that whole process connecting is very, very challenging when you're starting out, but once you have the platform set up … the advantage of continuous manufacturing is that the footprint is very small, so you can easily scale out so once you have the platform, it is very easy to put more of the these and also from a geographical perspective,” he summarizes.

Click the video to watch the full interview. Enzene Biosciences will be showcasing its services at the BIO 2024 convention in San Diego, Cali from June 3–6.

The PharmTech Group sat down with Himanshu Gadgil, CEO of Enzene Biosciences to discuss the benefits and challenges of continuous manufacturing of biopharmaceuticals.

Lee Cronin, founder and CEO of Chemify, discusses the combination of digital chemistry, robotics, and AI in the drug discovery space at BIO 2024.

The Intersection of Chemistry, Robotics, and AI in Drug Discovery (BIO 2024)

As BIO 2024 moves into full swing, Lee Cronin, founder and CEO of Chemify, a UK-based company specializing in building up digital chemistry for chemical research, discovery, and manufacturing, discusses how the combination of digital chemistry, robotics, and artificial intelligence (AI) are advancing the drug discovery space.

According to Cronin, the concept behind digital chemistry is to connect chemical reactions to synthesize molecules in standardized hardware, or in a standardized way. This involves “using a programming language so that we can very faithfully reproduce chemistry, on demand and also to a given quality,” Cronin states. The process of computation in digital chemistry is akin to running code on a computer, he emphasizes. “The concept of digital chemistry … is pioneering this ability to turn code into molecules reliably at scale, on demand, and also for the creation of quite complex molecules, and even APIs,” he adds.

The combination of programming language, robotic architecture, and the use of data and AI is creating a new approach to not just making molecules but discovering and doing process optimization, practically in one tool chain, Cronin explains. “What this means is that we should be able to go from the discovery process to dreaming up new molecules to then the optimization and scaling,” he says.

It is not necessarily easy to dream up a molecule 

 and then translate that into producing that molecule on demand because some aspects may not be worked out, or the yields might be low, or there may be other blocks, Cronin points out. “What Chemify has done is we've built a series of approaches that allow us to digitize chemical reactions and have them ready on demand—a bit like building blocks,” he states. This approach allows the user to pull a code and go from a chemical reaction A to B or from a chemical reaction A to D, depending on preference. “[This approach] allows you to go from your target that you dream of, to then work out what particular reactions you must do ahead of time, and, more importantly, allows you to restrict your search of chemical space when you're [early in the research process], when you're dreaming up new molecules to reactions you know how to do, [and] so this increases the speed that you can discover new molecules and make new molecules, and go through the cycle of design–make–test–analyze,” Cronin explains.

Of particular significance is that once a new molecule has been made, once the code has been established, that code can be reused and optimized to scale further down the line, Cronin points out. “You've got this programming language and these reactions and the robots that run it; [therefore], you're able to update your process continuously with the weight of the insights that you get,” he adds. With these chemical reaction insights, the data and methods can then be processed through AI, allowing for optimized yields, Cronin states.

View the video above for the full interview with Cronin. Cronin is speaking at the 

Lee Cronin, founder and CEO of Chemify, discusses the combination of digital chemistry, robotics, and AI in the drug discovery space.

Pharmaceutical Technology® spoke with Parviz Shamlou, senior vice-president of Science and Technology, Abzena

Impact of Biosecure Act on the Pharma Industry (BIO 2024)

As the bio/pharmaceutical industry gets ready for BIO 2024, the PharmTech Group sat down with Parviz Shamlou, senior vice-president of Science and Technology, Abzena, to discuss the impact of the Biosecure Act on the bio/pharmaceutical industry. Shalmou also provided his input on how companies can scale up manufacturing practices and how the use of continuous manufacturing in biopharma is progressing.

“We appreciate that [the Biosecure Act] is an important act designed to protect the health of citizens of this country. And we know we must do everything we can to avoid any unintended, potentially harmful use of our services as highlighted in the act,” says Shamlou. “[We] have put in place a robust contingency plan as well as a CMC [chemistry, manufacturing, and controls] strategy that are designed to mitigate any such risk to supply chain and the development of the assets that our clients bring to us.”

When it comes to continuous manufacturing in biopharmaceutical manufacturing, Shamlou believes the progress made in upstream processing can be made in downstream processing as well. “[In] the next few years, we'll see the introduction of continuous processing into downstream areas. And again, there are technologies out there, but those technologies will grow and will become, I believe, together with additional control strategy, more robust and will be ready for transition into manufacturing.”

View the video above for our full interview with Parviz Shamlou. Abzena is showcasing its services at the BIO 2024 convention in San Diego, Calif., which is being held June 3–6.

Pharmaceutical Technology® spoke with Parviz Shamlou, senior vice-president of Science and Technology, Abzena, about the impact of the Biosecure Act on the bio/pharmaceutical industry, as well as the progress of continuous manufacturing in biopharma.

Pharm Tech Group looks at the challenges surrounding the development and manufacture of ATMPs in more detail with Agne Vaitkeviciene, CEO of Memel Biotech.

Finding a More Optimal Way for ATMPs (BIO 2024)

Advanced therapy medicinal products (ATMPs) are a promising class of therapeutics that can provide useful treatment options for a wide variety of diseases. However, the development and manufacture of these advanced therapeutics is complex and challenging.

“The ATMP field is developing relatively slow,” explains Agne Vaitkeviciene, CEO of Memel Biotech, a Lithuanian-based specialized contract development and manufacturing organization. Development of ATMPs is hindered by factors such as the cost of the final product or the cost of manufacture, she specifies. One way to overcome such challenges, is “to find a more optimal way for manufacturing using innovative technologies using innovative solutions,” Vaitkeviciene adds.

However, manufacturing capacity and general expertise around ATMPs are also being discussed as potential hurdles to the advancement of these promising therapies. “I think the general capacity for biomanufacturing, not just ATMPs, is already an issue, especially in Europe; a lot of manufacturing was relocated somewhere else,” Vaitkeviciene says. Yet, a lot of the ATMP manufacturing is now returning to Europe and the United States, she continues, explaining that there has also been a push from policymakers to increase capacity.

“There has been a lot of [action to improve ATMP capacity] to catch up with the capacity manufacturing needs,” Vaitkeviciene notes. “And I think it will, [capacity] will catch up [with demand], I don't think it will go into a critical or crisis stage, I'm positive in that.”

Watch the video for the full interview. Memel Biotech will be exhibiting at the 2024 BIO International Convention in San Diego, Calif., from June 3–6.

 holds a BS in Molecular Biology (Vilnius University, Lithuania) and an MS in organ, tissue, and cell donation for Cell Therapy (University of Barcelona, Spain). Since 2006, she has been working in the field of cell therapy and ATMP manufacturing under GMP conditions. In 2013 Agne Vaitkeviciene co-founded a life science startup company and managed its activities in the field of advanced therapy medicinal product (ATMP) research and manufacturing as CEO until 2019. Since 2019, she has been actively involved as an expert in EU programs, such as IMI2, EIT Health Innostarts, and consults biotechnology companies in life science product development management. For the past five years, Agne has been actively involved in life science expert groups within Lithuanian governmental organizations such as the Innovation Agency of Lithuania and Invest Lithuania. Association LithuaniaBIO elected Ms. Vaitkeviciene as a Vice-President in 2019 and delegated her responsibilities of coordinating foreign affairs and startup support activities within the Association. In 2020–2023, she was the Executive Director of LithuaniaBIO. In 2020, Agne joined Cureline Group as a COO of Cureline Baltic and later, together with Dr. Olga Potapova, founded Memel Biotech in 2021 in Klaipeda, Lithuania. Currently, Agne is responsible for overall Cureline Group activities in Lithuania, provides leadership for the ATMP CDMO program, and coordinates BD efforts in the EU region for member companies of the Cureline Group.

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