Chapter I: “My Journey into Biopharma”

Introducing Kate Cotter, Melissa Hoare, Robert Byrne, and Shada Warreth – all from NIBRT, Ireland.

What inspired you to move into biopharma?
 

Kate Cotter, Associate Director of Training: I was always interested in science in school. I studied analytical science in Dublin City University and from there went on to complete a PhD in molecular and cellular biology in University College Dublin (UCD). During my PhD, I was able to study in the US and I loved seeing the advances in medicines. At the same time, NIBRT was actually based in UCD while its current facility was being built. I was able to gain access to some of their automated equipment to advance some of my experiments rather than doing it manually – and from there I went to work for them! 

During my time with NIBRT, I have had the opportunity to work with manufacturing companies across Ireland and further afield to review their processes. I have helped design training programs to ensure their teams have a deep understanding of the importance of each aspect of their role and then eventually the impact on the patient. Bringing the job back to impact on the patient always helps focus the mind.

Melissa Hoare, Senior Training Manager: Biopharma is a very exciting industry, with new products constantly being developed, all with the aim of improving people’s health and quality of life. These molecules have a very high success rate in coming through clinical trials, and many of the drugs that are on the market are being used to treat life-threatening diseases. They also tend to have fewer side-effects when compared with small molecules, making them more beneficial for the patient. 

This is a rapidly growing area with numerous new molecules in development that may potentially be used to treat a very wide range of diseases for which there was previously no treatment. It is very exciting to be part of such a constantly evolving sector.

Robert Byrne, Training Team Lead: Believe it or not, I have 15 years of experience as a trained fitter in natural stone, porcelain, and ceramic tiling (11 of which have been self-employed). In 2001, I started a contracting business. The company grew, and I found myself working with some of Ireland’s largest construction companies, including Sisk’s and McNamara’s, as well as established companies such as Rocca Stone & Marble and Porcelanosa. 

Having achieved most of my career goals in the construction industry, I decided to retrain in 2010. Since then, I have completed a level 9 certificate in bioprocessing at the Atlantic Technology University (ATU) Sligo, an Honors Degree in Medical Device Technology at Technological University Dublin, Bolton Street, and a Bachelors in Pharmaceutical Science Biological degree in ATU Sligo.

I chose the biopharmaceutical industry because I’ve always been interested in science. In addition, the industry is strong and growing considerably; the pharmaceutical and biotechnology industries have continued to succeed even in the worst economic times.

The specificity and capabilities of biologics are what makes the biopharma field so exciting and interesting for me. Perhaps the most significant advantage of biologics when compared with small molecules is their potential for treating diseases that were previously thought to be either incurable or difficult to treat. Even currently treatable diseases may benefit from biologic treatment.

Shada Warreth, Senior Training Manager: I come from a pharma background, but I got into the biopharma industry when I joined NIBRT in 2010. It wasn’t necessarily that I was keen to move to the biopharma industry at that point – but an opportunity came up in NIBRT for a commissioning role of the new facility that I couldn’t not apply for. It was meant to be a three-month job, but fast forward 12 years and I’m still here and loving it! I don’t see myself going back to traditional pharma.

The diversity and the complexity of the processes keeps my interest. For example, in monoclonal antibody production you are using cells to produce the protein of interest. But no two cells are the same and no two batches are the same so it’s a fascinating area.

How does the analysis of biologics compare with traditional small molecules?
 

MH: Biologics are very large and complex molecules. They are significantly different in terms of make-up and structure in comparison to small molecules. Therefore, biopharmaceuticals demand highly sophisticated methods for their analysis and characterization. Analysis of biopharmaceuticals can be a complex task because a variety of different aspects need to be assessed.

RB: Yes – and throughout all stages of production, many of the physicochemical characteristics of biopharmaceuticals are liable to change. We must rely on various methods and technologies, including HPLC, protein assays, and ELISA.

KC: Biologics are manufactured by growing cells, which, like any living thing, can change and evolve. Any changes in how they grow can affect the product being made. As a result, the analysis needs to ensure the cells are doing the same thing and making the same product each time, ensuring that patients receive a consistent treatment. As Robert says, detailed, continuous, specific analysis is required throughout the process to identify any changes and knock on effects as soon as possible in the manufacturing operation.

What’s the next “big thing” in biopharma?
 

MH: The industry is constantly innovating, with new therapies emerging quickly. In many cases, biologics are being launched to treat diseases for which there may have been previously no cure. It is amazing to see patients receiving these life-changing treatments. The industry is changing very rapidly and new advancements in technology will hopefully make it quicker and more economical to develop and manufacture these drugs. 

RB: There is a lot of discussion right now about advanced therapy medicinal products (ATMPs), which are medicines based on genes, tissues, or cells. They provide game-changing new opportunities for disease and injury treatment, and are considered the next big thing in the biopharma industry.

KC: I agree with Robert about the importance of ATMPs. In line with this, NIBRT has just opened an extension to its facility purpose built for training and research on ATMPs. Cell and cell gene therapies have the potential to provide life changing treatments and can also be personally tailored for individuals. 

SW: Yes – cell and gene therapies for sure are a drug modality to watch in the future! However, there is also another trend that I think deserves attention: Pharma 4.0/5.0. This wave of pharma innovation is all about using advanced tech, including AI, big data, and automation, to create safer, more personalized medicines – faster and more efficiently. It’s the pharma industry’s tech-driven evolution – such as how smartphones transformed phones!

Complexity Emerges

A couple of trends emerged from our conversations with the lovely people at NIBRT. But perhaps the most notable is that both the intrigue and the challenge found in the biopharma industry stems from inherent complexity. In case you skipped the intro [add link], we should point out that Agilent’s insightful Andreas Mielcarek is on hand for the entire “So You Want to Be a Biopharmaceutical Analyst” series.

Andreas, do you see this complexity reflected in your conversations in the world of biopharma? 

In the biopharma industry, the complexity of biologics presents both inspiration and challenges. These large molecules, central to innovative therapies for once incurable diseases, require a wide range of sophisticated analytical methods, including HPLC, for the thorough characterization needed to confirm the purity, efficacy, and safety of biopharmaceuticals. Biologic complexity encourages innovation, but also presents significant obstacles in the development, manufacturing, and quality assurance phases, where HPLC and similar methods are critical. The industry thus navigates a delicate balance between the excitement of scientific breakthroughs and the practices of commercialization, with professionals forging ahead by mastering biological complexities and the analytical techniques required, shaping the biopharma landscape amid ongoing discoveries and challenges.

Bioanalytical chemistry is critical in biopharmaceuticals to ensure the safety and efficacy of biologics. Our Biopharma Application Book provides a guide to bioanalytical techniques, with the aim of advancing biopharmaceutical development and contributing to innovative therapies.

Chapter II, ‘The Wild World of mAb Analysis’ by Peter O'Byrne, shifts the focus to monoclonal antibodies (mAbs) in bioanalytical chemistry. It explores the role of mAbs in biopharmaceuticals, describes their development, production and the sophisticated analyses required for their characterization, and highlights their importance in the field of protein-based therapies.

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