Hi, Mark Cappucci, Pre-Formulation Manager at Lonza Tampa, and I’d like to share how our team is driving innovation in early-stage drug development with precision powder micro-dosing. Every day, we work closely with our partners to streamline product development, accelerate clinical timelines, and ultimately bring life-saving therapies to patients faster.
What is Micro-Dosing?
Micro-dosing is a game-changer for early-phase drug development. It allows us to dispense a precise quantity of a drug substance into a capsule, helping pharmaceutical companies quickly assess whether a candidate is worth further investment. At Lonza, we understand how critical these early decisions are, which is why we leverage our expertise and advanced technology to make the process as efficient and cost-effective as possible.
Why Powder-in-Capsule (PIC) Evaluations?
One of the best strategies we employ is powder-in-capsule (PIC) evaluations. Unlike traditional formulation development, PIC minimizes complexity, reduces waste, and simplifies analytical testing. With this approach, we help our clients:
- Streamline formulation development
- Reduce drug substance usage
- Speed up the path to first-in-human studies
Delivering Precision with Xcelodose® Systems
At Lonza, we take pride in using cutting-edge equipment like the Xcelodose® Precision Powder Micro-Dosing system. With its ability to precisely weigh and dispense drug substances into capsules, this technology allows us to:
- Micro-dose as low as 0.1 mg per capsule
- Fill 200-250 capsules per hour with incredible accuracy (2% RSD)
- Eliminate unnecessary formulation development steps
Using Xcelodose®, our clients can accelerate development timelines by approximately 50%, shaving off up to six months on the road to first-in-human studies.
Best Practices Developed from Hands-On Experience
With over 600 batches and more than 200 APIs processed, the Tampa team has gained extensive hands-on experience. Along the way, we’ve developed best practices that enhance efficiency and reliability, including:
- Understanding API/capsule interactions for better outcomes
- Optimizing sample preparation and capsule emptying techniques
- Evaluating excipient blends to ensure seamless processing
- Translating analytical methods to API-in-capsule evaluations
- Implementing calibration protocols that exceed standard equipment capabilities
Making a Real Impact in Early-Phase Clinical Studies
As someone deeply involved in product development, I see firsthand how our micro-dosing solutions positively impact early-phase clinical studies. Some of the key benefits include:
- Faster Product Development: We reduce drug substance usage, eliminate unnecessary compatibility testing, and simplify analytical processes.
- Higher Efficiency: Our precise dispensing technology provides full traceability and supporting documentation for every capsule produced.
- Cost Control: By minimizing waste and formulation development costs, we enable clients to prepare multiple dosage strengths using a single process.
At Lonza, we’re not just providing a service; we’re your dedicated partner in drug development. Our precision powder micro-dosing systems, combined with our formulation expertise and integrated technologies, allow us to tailor solutions to your specific needs.