The field of bioassays is critical to the development of biologics — from understanding drug behaviour to monitoring safety and efficacy. But it’s also a space many scientists find themselves in unexpectedly, without clear pathways or preparation.

We spoke with Melody, a bioanalytical expert and Educo Life Sciences trainer, about how she got started, what new scientists should expect, and why hands-on experience is key to success in this evolving and technically demanding area.

An Unexpected Start: From PhD Lab Work to Bioassay Specialist

Melody’s entry into bioanalytics came during her doctoral research, where she studied the immune response to biologics.

“It was during my PhD where I was working on the unwanted immunogenicity of therapeutic proteins — recombinant human proteins, and also antibodies. That was becoming a hot topic at the time.”

Her work involved developing and running a variety of assays in animals, testing for anti-drug antibodies (ADAs) — which are key indicators of immune responses to biologic treatments.

“I ran a lot of assays in the lab, looking for ADAs after animals were treated with the biologics of choice. And that’s really where my journey in bioanalytics began — through hands-on lab work.”

This foundational experience gave her a strong understanding not only of analytical techniques, but also of the real-world variability and problem-solving involved in running complex biological assays.

The Reality of Bioassay Complexity

When asked what challenges professionals new to bioassays can expect, Melody doesn’t sugar-coat it: the field is complex — technically and conceptually.

“Bioassays, in the broader sense, include ligand-binding assays and cell-based assays. They can be very complex modalities — and it all depends on what you’re trying to measure.”

One of the most important lessons for newcomers is recognising the diversity of assay types and the purpose they serve:

• PK assays to measure drug levels in biological fluids
• ADA assays to monitor unwanted immune responses
• Biomarker assays to assess pharmacodynamic effects

Each has different performance requirements, different readouts, and a different place in the development lifecycle.

“Getting to know your drug and getting to know your assay is absolutely essential. But that can be hard, especially because we’re always working in biological matrices — whether from humans or animals — and they bring their own challenges.”

Melody explains that understanding the background noise in these matrices is vital. Proteins, enzymes, or antibodies present in the sample can interfere with results, especially in high-sensitivity assays.

“You need to think about everything that’s floating around in the matrix. That can affect how your assay behaves — and you need to learn how to deal with that if you want reliable data.”

Advice from Experience: Hands-On, Then Step Up

Melody’s strongest advice for anyone entering the bioassay space is to get their hands dirty — figuratively and literally.

“From my experience — and the way I came into the field — hands-on experience in the lab is everything.”

Before managing teams or leading projects, she spent years running assays herself. That direct exposure, she says, gave her the insight needed to troubleshoot, refine protocols, and eventually lead others.

“You can’t really supervise, manage a unit, or abstract yourself from the technical details if you don’t understand them first. Run the assays. Run them over and over again. Understand the pitfalls and learn how to solve them.”

She adds that this hands-on work also gives professionals more confidence when collaborating with analytical teams, CROs, and regulatory stakeholders later in their careers.

Adapting to an Evolving Field: Technology, Sensitivity, and Strategy

One key theme Melody returns to is staying agile. Bioassay technologies and expectations evolve quickly — especially in areas like biomarkers and immunogenicity, where newer therapies demand increasing assay sensitivity.

“There are always new technologies and equipment. Instruments are getting more sensitive, which is great — but higher sensitivity brings its own challenges.”

For example, ultra-sensitive assays might detect previously invisible background signals or nonspecific binding — leading to new troubleshooting demands.

“You need to understand not just how the technology works, but what its limitations are. Every improvement introduces complexity — and that’s where your real-world problem-solving becomes important.”

To keep up with change, Melody emphasises continuous learning. She recommends:

• Conferences to stay informed on new developments
• Courses to reinforce foundational understanding
• Peer discussion with experienced scientists in industry or CRO settings

“Learning from people who have done this for years is incredibly helpful. That’s why I put so much value into the courses I now teach.”

What You’ll Learn in Melody’s Bioassay Course

As a trainer with Educo Life Sciences, Melody now helps new professionals build the very foundation that helped her succeed.

“The course I teach covers the basics: how these assays are structured, what they’re used for, and how you develop and validate them.”

But it’s not just theory — the course includes hands-on case studies based on real-world challenges.

“We spend time on troubleshooting. What goes wrong, and how can you fix it? What are the typical pitfalls, and how do you prevent them? That practical insight is something people really benefit from.”

The course also helps delegates understand when and why to choose different assay formats — a skill increasingly important in multidisciplinary teams where regulatory, clinical, and manufacturing inputs must align.

Final Thoughts: From Scientist to Educator

Melody finishes with a simple but powerful message: every expert starts with experience.

“There’s not much more to it than that. You start off, gain experience, and eventually you have enough experience to teach. That’s the path.”

Her own path — from PhD researcher to CRO leader to industry trainer — shows how a deep, practical understanding of bioassays can open many doors across biopharmaceutical development.

Ready to Build Your Bioassay Career?

Educo Life Sciences offers expert-led training to help you master bioassay development, troubleshooting, and interpretation. Whether you’re new to the field or deepening your expertise, this course equips you with the insight and confidence to succeed.

👉 Explore Bioassay Training Course

(Bio) Assays in Pre-Clinical and Clinical Development for Biopharmaceuticals and Cell & Gene Therapies

Potency Assay Lifecycle From Development to Validation, QC for Biopharmaceuticals and Cell & Gene Therapies