I started in biotech right out of university, doing everything from operations to process sciences. What pulled me toward automation was the ability to really see how things worked. During a large capital project, I discovered I had a knack for automation. That insight, along with my early partnership with Leo, who shared a similar mindset, led me to AES. We both believe great automation engineers should be well-rounded—understanding process, equipment, and controls holistically.

When it comes to automation, many clients initially focus on hard metrics like time savings, yield improvements, and reduced labor costs. But as Chris and Matt explained, it’s often about targeting critical stages of the workflow where automation can do more than just save time but instead save entire batches.

Chris shared, “The biggest drivers we see are throughput and quality consistency. You might be trying to speed up the process, but more often, clients come to us because they’re dealing with failures, missed specs, product waste, or operator variability. Automation gives you the tools to eliminate that inconsistency.”

Matt echoed the importance of error reduction, especially where data is involved. “Manual processes are prone to mistakes, especially in documentation. Automating data capture through MES systems like Syncade, for example, cuts down on human error and ensures everything is logged in real-time, reducing compliance risk.”

While labour reduction is sometimes part of the discussion, both emphasized that it’s more about redistributing operator time to higher-value activities, such as oversight and troubleshooting.

It depends on the level of customization. For standard, off-the-shelf equipment, the baseline expectation is compliance with Good Manufacturing Practice (GMP) standards. This includes a comprehensive documentation package with design documents, operating manuals, and qualification protocols. Specific regulatory requirements, such as data integrity, audit trails, and compliance with 21 CFR Part 11 or EU Annex 11, must also be clearly addressed.

For partially or fully customized equipment, expectations are higher. End users look for a risk-based design approach aligned with GAMP 5 principles, full traceability from user requirements to testing protocols, and an integrated quality risk management process. OEMs must justify their design decisions, evaluate potential failure modes, and proactively collaborate with validation and quality teams. Full-service qualification covering DQ, IQ, OQ, and PQ support is often expected to streamline implementation.

In biotechnology operations—where precision, compliance, and system uptime are critical—AES provides comprehensive maintenance and service programs to ensure your equipment consistently delivers optimal performance. Our support extends asset life, minimizes downtime, and safeguards process integrity from R&D through to production.

Consider a mid-size bioproduction facility working on late-stage clinical material. When a valve unexpectedly failed, they didn’t have an emergency response contract or the part in stock. The result? A total batch loss and a five-week delay on a critical trial. “That kind of impact goes far beyond repair costs,” says Emily. “It affects timelines, team morale, even investor confidence.”

In highly regulated environments, delays can trigger a domino effect, pushing back validations, disrupting supply chains, and impacting patient access. With each hour of downtime, opportunity costs grow.

CMOs need flexible manufacturing solutions in order to support multiple clients with varying needs for their products. Single-use bioprocessing can help:

• Adapt quickly to differing batch sizes without major facility reconfigurations. This allows greater flexibility in production because traditional stainless-steel setups typically require modifications to accommodate different batch volumes. With single-use systems, production can scale seamlessly by swapping out bioreactors, tubing, and consumables as needed. This minimizes downtime and provides better support for multi-client workflows.
• Support multiple bioprocesses while reducing the risk of cross-contamination and batch failure. Stainless steel systems require extensive cleaning validation between runs, but single-use systems provide sterile components for each run, nearly eliminating any risk of contamination. This allows CMOs to run multiple client projects simultaneously, improving operational efficiency and enabling quicker product changeovers. 
• Reduced Downtime by eliminating the need for cleaning, sterilization, and validation processes. Stainless steel systems require CIP and SIP processes, followed by validation to guarantee compliance before the next run can start. Single-use systems use pre-sterilized and disposable components that allow quick transitions from one batch to the next while maintaining sterility and compliance.

A common denominator in Todd’s career has been the constant ambition of helping people and improving accessibility of lifesaving therapies for those who need it the most. His passion for science began in his early teens. Todd was fascinated by the idea of curing cancer.  

Todd obtained a Bachelor of Science (BS) in Biology at the University of New Hampshire and a Doctor of Philosophy (PhD) in Molecular Biology and Biochemistry at the UCONN Medical Centre in Farmington, CT. 

As he progressed through University, he developed a keen interest in understanding diseases at a molecular level. How does a cell transition from normal to malignant, and how can that process be prevented or reversed? This curiosity is what drove his passion for cell biology and ultimately led him to where he is today.

CMOs serve multiple clients, each with unique manufacturing requirements. Without flexibility, they risk being trapped in a one-size-fits-all setup that limits their product pipeline and reduces business opportunities. Tech transfer enables CMOs to customize production suites for greater adaptability by: