Product Design and Preformulation Development

Accelerate your Drug Development with Lonza

Product Design and Preformulation Development Expertise

We apply extensive product design, preformulation, and technology expertise to successfully advance challenging compounds and improve overall speed to market. We offer premier depth in addressing bioavailability challenges and modulating pharmacokinetics to meet target product profiles. Recognizing that every molecule presents its own set of challenges, our drug development teams combine our unique drug and process design capabilities with a premier range of technologies to deliver the right solution for your compound and drug product.

Building on decades of drug design, development and scale-up experience over thousands of compounds, our multi-disciplinary project teams routinely develop custom approaches to enhance the bioavailability, efficacy, and performance of drug candidates across oral solid and inhaled product applications. Best practices in compound characterization and technology selection have been developed, as well as specialized processing equipment and techniques that result in robust, scalable solutions and accelerated development timelines. Phase-appropriate processing is in place for oral solid and parenteral product development from proof-of-concept studies, early and late phase clinical trials, and commercial manufacture.

We focus on robust problem statement definitions and data-driven formulation design to help ensure accelerated development and seamless scale-up

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Formulation selection and in-vitro screening for oral bioavailability enhancement

Drug Development From Proof Of Concept To Commercialization

We work together to fully characterize your compound and its problem statements, and tailor the formulation and drug-delivery system to meet rigorous product specifications, even for the most challenging molecules. Our core technologies and expertise address key challenges presented by today's candidate compounds, including:

bioavailability enhancement, solubility and dissolution rate issues
targeted delivery, extended or delayed release, zero order and dual release
delivery of high-potency and low-dose compounds
accelerated screening and development: powder-in-capsule studies
abuse-deterrent formulations
taste- and odor-masking solutions (pediatrics)
pulmonary/inhaled delivery
parenteral delivery

We have extensive experience with a range of proven enabling technologies, many of which have been developed or advanced by our teams:

solid dispersions
particle size reduction
lipid based formulations
modified- and targeted-release formulations
fixed-dose combinations
multiparticulates
engineered particles for inhaled applications
sterile fill / finish for parenteral applications

We employ efficient, science-based flowchart methodologies to identify the best formulation and delivery approaches for each drug candidate and then use production and testing capabilities appropriately scaled for each phase of development. Specialized facilities are in place to support highly potent compounds and the use of processes employing organic solvents.