Every vial, every data point, every Drug Substance — each carries the effort of many unseen hands.

Behind every successful production run is not just one department, but the seamless collaboration of an entire manufacturing ecosystem.

Before each new campaign begins, our manufacturing team partners closely with cross-functional colleagues to ensure every unit operation is ready for success. We align early on critical process parameters, scale‑up considerations, and phase‑appropriate controls, grounding each decision in the data transferred from development. Through multiple discussions between the Technology Transfer (TT) and Manufacturing teams, we establish a shared understanding of technical risk, mitigation strategies, and the operational priorities that keep execution smooth and predictable.

At the same time, our Materials Management & Logistics (MML) team carefully reviews the Bill of Materials (BoM) and arranges all materials to meet the production schedule. During execution, the Quality team ensures every sample submission and test item is properly captured and released on time. This orchestration is intentional — every function operates with a unified focus on batch success, regulatory alignment, and uninterrupted productivity.

Every document, every formula, every parameter — all are meticulously reviewed and verified by QA, MSAT, and PD teams before the first step of production. This rigorous readiness framework ensures we enter the suite with clarity, confidence, and compliance already built into the workflow. It is how we safeguard data integrity, minimize deviations, and maintain consistent, phase‑appropriate control across every campaign.

Throughout the process, we maintain transparent communication, providing real-time updates to our clients and ensuring every operation is well coordinated. Our clients never have to wonder what’s happening inside the suite — we keep them informed, engaged, and confident at each stage. Every unit operation is planned in detail, enabling us to deliver on time and in full with reproducible precision.

In the end, what makes each batch a success is not just the process itself — it’s the people behind it.

Every dedicated teammate who is willing to contribute, stay focused, and take ownership plays an indispensable role in turning challenges into achievements. This culture of accountability, collaboration, and scientific discipline is what sets Bora Biologics apart — and it’s why our partners trust us with their most important programs.

Because behind every successful batch, there’s a strong, united manufacturing team — and a CDMO committed to doing things the right way, every time.

About the Author
Mandy Tai is a Supervisor of Manufacturing–Downstream at Bora Biologics, bringing over 15 years of hands‑on experience in biologics purification and large‑scale GMP operations. Since joining Bora Biologics in 2022, Mandy has played a key role in leading downstream manufacturing activities, ensuring each campaign is executed with precision, compliance, and strong cross‑functional coordination.