Enabling a Healthier WorldTM. For many of us working in the medical and biotech field, this expression gives us our purpose, and defines the reason behind why we do what we do. We all aspire, during our formative years, to do something purposeful in life – something that would make an impact. For some of us, that meant engaging directly with the community as doctors, paramedics, and so on. For me personally, I was fascinated with the opportunity and possibilities of scientific innovation, and the broader reach and impact it would have on the community. Indeed, we have all witnessed the impact that the role of a scientist has had through the COVID-19 pandemic. In my case, I have been fortunate to have had various opportunities that have allowed me to contribute towards cutting-edge medical innovation, leading all the way up to my current role at Lonza with an organization that fortuitously, shares that very purpose.
Research and Development in a CDMO
Lonza, a contract development and manufacturing organization (CDMO), enables customers working across various types of technologies, such as biologic drugs, cell & gene technologies, small molecules, and other health ingredients, to develop their products in a way that make them accessible to the patients needing them. Lonza has a global footprint with over 40 sites on 4 continents around the world. Our site located in Houston, Texas is the largest dedicated cell and gene therapy facility in the world. Cell and gene therapies offer transformative treatments to patients suffering from diseases affected by genetic mutations, leading to cancer or otherwise fatal health disorders, by enabling us to deliver healthy copies of the defective gene through a viral vector – either directly or through the modification of patient cells. It is here at our Houston site, that we have the unique opportunity of innovating and fabricating cell and gene therapy drug products, while doing so cost-efficiently at commercial scales that would directly benefit the patient.
Lonza is one of the few CDMOs that has placed a strong emphasis on innovation, with investment in R&D to develop and implement advanced manufacturing platforms and technologies. In light of their potential to cure debilitating diseases and their well demonstrated efficacy, cell and gene therapy products see very rapid clinical development. Standardized, scalable and robust manufacturing platforms are critical to allow product innovators to focus on the therapy while being assured of a successful manufacturing pathway, independent of stage of development and scale.
Additionally, with a rising number of clinical trials and a growth in the number of product approvals, the demand for cell and gene therapies in the market is constantly increasing and taking over the industry’s capacity to keep up with manufacturing. According to a report on cell and gene therapy market forecasts by Arizton1, the cell and gene therapy market is projected to grow at a compound annual growth rate of over 39% over the next 5 years, bringing an added emphasis on the need to devise and develop platforms critical to meet this demand. Considering all of the above, one can see where Research and Development would bring in added value. As scientists in a CDMO, we are able to work directly with our customers to optimize the efficacy of their product, and also develop robust platforms, for production as well as for analytics, that allow for these products to be scaled and made available readily to the community. This opportunity to make real-world impact, and knowing that what we do matters, is what drives us as scientists.
Reflecting on my career as a scientist
“It’s about the quest, not the grail.”
– Dr. Isaac Asimov, Author and Professor of Biochemistry, Boston University.
I first started working in a laboratory as a research assistant during summer break of graduate school. My earliest memories of the lab are as a fledgling grad student straight out of college, learning to synthesize gold nanoparticles for cancer therapy. That summer turned out to be a pivotal moment for me, hooking me on and defining my future career in the lab. Over the years, I have worked in many areas of the biotech industry ranging from process development to manufacturing, and several roles in between; however, I constantly found myself drawn towards research. Working in life science is fulfilling and purposeful. Life science research is also an opportunity to be inquisitive. Curiosity and critical thinking are of crucial importance when considering a career as a scientist, and so is being at the forefront of innovation – therefore, keeping abreast on current cutting-edge technologies is a must.
The role of a scientist is exciting and fulfilling, but as in all careers, it is not without its challenges. Research can often be tedious, or even frustrating, when one has to spend months together trying to figure out a solution to a problem. Often problems seem intractable, with solutions being elusive despite meticulous and persistent experimentation. Sourcing critical input from others and being able to see the forest from the trees is important for success. It becomes necessary to look at the problem from a wider viewpoint. I often think of it as being able to solve a jigsaw puzzle, but without an idea of what the final image would look like – we would need to see where the different pieces of the puzzle fit in order to visualize the complete picture in its entirety. Having structure and focus helps. On a similar note, there is a sense of pride and satisfaction felt after having achieved the solution to a research problem – a sense of accomplishment of having put it all together. Research is more a marathon rather than a sprint – a notion that I have come to learn over the years. We are in it for the long haul.
We bring our individual experiences to build collective expertise
My observation has been that successful collaborations make it all work. I work in one among the 17 R&D locations at Lonza which are developing pioneering technologies. We focus on viral vector development in a close-knit but growing team of talented research associates and scientists from varying backgrounds and different levels of experience. Being a relatively small group, we are constantly brainstorming about ongoing projects and exchanging ideas for future work. We also extensively leverage the combined knowledge and expertise of our R&D colleagues across the globe through focused interactions, technical forums and project reviews. For me personally, this has allowed the opportunity to advance in my area of expertise, lead a number of projects and contribute to many others. I have also been able to get involved and expand on other subject matters, from which I have benefited tremendously.
Our team in Lonza Houston works on the development of manufacturing and analytics platforms for viral vectors, including adeno associated virus (AAV) and lentiviral vectors. Viral vectors are used to package genes that express therapeutic payloads into the cells of patients suffering from ailments involving genetic deficiencies. When I joined Lonza in 2017, one of my first projects was to generate and optimize a suspension HEK293 clonal cell line, which is a key component of the manufacturing platform needed to produce AAVs. Over a long period, many efforts went into defining and shaping this product, and finally, five years later, we are at a place where we can offer this cell line for GMP use, having been received well by customers developing AAV therapies. As the researcher on this project myself, I can tell that a lot of time and toil went into making this project a success. I can vouch for the long hours inside biosafety cabinets, and under the microscope, that went into realizing this product. However, I am also aware that it did not end there.
So, what are the different groups that operate together to bring a product out into the market, and how do they interact? Ideas for new projects are typically determined jointly with input from groups such as Commercial Development and Licensing based on anticipated market needs. This is then translated by R&D into a detailed set of targets for the product or process and simultaneously, a business case is developed to objectively assess the value of the technology. A product or process that is developed gets transferred into our Process Development division, who optimize it to meet a client’s need. From there, the process is assigned to MSAT (Manufacturing, Science & Technology), who transfer the process into Lonza’s GMP manufacturing suite and get it ready for execution. Similarly, an assay that is developed within R&D is transferred into our Bio-Analytics Services group for qualification, and eventually assigned to Quality Control. These are just some of the groups that function together during the early phases of product development. There are several others that work very closely to provide support on an as-needed basis.
Products go through rigorous development, quality checks, and validation before they are ready for the market. In that regard, I am appreciative of the many different groups that worked collectively over several years to ensure that the product we developed was properly scaled, tested and vetted in order to ensure the quality needed to meet the requirements of the field. The example above is one among many projects that are currently ongoing, which could not have happened without critical team support. Ultimately, our internal collaborations – both within as well as across teams – are what make us successful.
A solid support structure in an ever evolving environment
The phrase “change is the only constant” has probably not rung true ever before as much as during the COVID-19 pandemic. In this day and age, times are becoming increasingly challenging as families are shifting towards managing careers alongside families. The pandemic has brought our workplaces home and blurred our definition of what used to be work-life balance in the process. Given the status of the current workplace as it is, it has become increasingly important to find our support structure and understanding in our colleagues. That is why it becomes imperative to recognize this in the workplace.
Scientific research can often be associated with extended hours, whether in the laboratory or poring over literature. There can be times, depending on the experiment, where the occasional odd hour or weekend work may be necessary. Being a mother of young children myself, I can relate to the challenges of balancing the demands of research with the routines or uncertainties that parenthood brings on. Sometimes, the nature of a project may be pressing and data is needed as soon as possible. Other times, there may be an unexpected equipment malfunction. Additionally at a CDMO, the client may have an urgent request that would have us reprioritize our schedule. I can count on a number of instances where I needed to rely on support to pick up my child from school, or had to make alternate arrangements to deal with an ongoing experiment because I needed to stay back to tend to an ill baby. It is important to recognize that managing a job in the lab alongside family responsibilities is often a balancing act – a struggle that is becoming increasingly common within working households of all backgrounds of employment. At times, there are choices that need to be made. An understanding workplace can become a valuable resource if one has strong relationships within work to provide professional support in instances like these.
This solidarity has to continue outside of the work sphere as well. Equity is possible when organizations identify and offer the support needed to build such an environment. To that effect, we have efforts in place that recognize and promote matters such as Woman’s Empowerment, and cultivate Inclusion and Diversity within the workplace, to name a few. Active participation from personnel at all roles and stages of their careers focusing on topics such as these helps foster close cooperation and promotes a sense of belonging. I realize that these conversations, while present, are not persistent in the industry, and the establishment of platforms to recognize these challenges is a step in the right direction. Furthermore, parity begins at the top. An inclusive leadership team provides the vision of equal representation and a sense of optimism that it will eventually trickle down the ladder. To me, this is inspiring because it presents hope for the possibility of growth and elevation.
Ultimately, the credit for our success goes, without a doubt, in large measure to our people who make up the company. The process of bringing a therapy out to the patients is an arduous one. Undeniably, several partnerships are needed to make this happen. We are proud to partner with our customers in the sphere of manufacturing; as are we of our colleagues, who make it possible to succeed through this rigorous process with solid teamwork. With a growing workforce of over 15,000 people, Lonza is expanding rapidly. With this impending growth comes a great deal of new opportunities to make progress, and I look forward to leveraging these opportunities through further collaborations. Consequently, I hope to continue to find solutions to further challenges that we face together, that we will proceed to achieve as we collectively work to make a meaningful difference.
1. Cell and Gene Therapy Market Report, Global Outlook and Forecast 2022-2027, Arizton Advisory and Intelligence.
Vijetha is a Scientist working in Research and Development, in Lonza’s Cell and Gene Technologies space. Based out of Houston, Texas, she has nearly 12 years of experience in the biopharma industry. Vijetha started her scientific career at Lonza in 2017, and has since contributed to a variety of projects focusing on developing platforms and analytics for viral vector production. She currently leads projects that emphasize on developing assays and evaluating tools to characterize lentiviral vectors.
Originally from India, Vijetha has a background in biotechnology from RVCE in Bangalore, and graduated from Rice University in Houston with a degree in Bioengineering. Prior to joining Lonza, she worked at Nanospectra Biosciences, a medical device start-up that develops nanotechnology-based therapies, where she had the opportunity to dabble in several roles such as process development, manufacturing and quality. She believes that this former experience served as a solid foundation to equip her with the skills required to succeed in Lonza’s CDMO environment.
Vijetha credits her family for her strength and success. As a mother to two young boys under the age of six in a dual career household, she is passionate about advocating for working mothers in science, and is constantly exploring ways to build a support system around her, balancing work and family.