To produce a pharmaceutical dosage form, manufacturing processes, product characteristics, and product testing must be specifically defined to ensure that the product is safe, effective, and of consistent quality. We appreciate that successful delineation of these chemistry, manufacturing, and control (CMC) activities is a crucial part of the product-development lifecycle. Our integrated services across drug substance, particle engineering and drug product incorporates the appropriate CMC activities to satisfy global regulatory authorities.

In close collaboration with you, our Regulatory Affairs team will write a CMC dossier suitable to the stage of clinical development of your product manufactured by Lonza. This team excels in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications.

This presentation will cover phase-appropriate development approaches and supply chain solutions for integrated drug substance and drug product projects that can accelerate program timelines and reduce overall complexity and risk.

View on-demand presentation

Avoiding CMC failures through phase-appropriate clinical development and supply chain setup

CMC capabilities throughout development

We have extensive expertise in CMC development to satisfy the regulatory requirements of authorities worldwide. Our scientists and engineers carefully assess the physicochemical properties of the drug compound and identify the optimal dosage form and delivery system, such as capsules, tablets, inhaled, injectable, or intravenous formulation. Then, we carefully optimize the manufacturing process, ensuring that product characteristics remain consistent as the manufacturing process is scaled up.

Our proprietary technology-selection methodologies, predictive models, reference tools, flow-chart methodologies, testing methods and process equipment enable streamlined product design and development and smooth progression through all development stages. At each stage of development, we work together with you to identify the critical-to-quality attributes and important formulation and process parameters. A robust control strategy is implemented to ensure a quality-by-design (QbD) approach and seamless scale-up to commercial manufacture.

Related content

Innovative Approaches to Tailoring Particle Size Distribution
Webinar on-demand
Navigating CMC regulatory requirements for accelerated commercialization
Webinar on-demand
On-Time Regulatory Documentation
Tech brief
Science of Scale for Spray-Dried Intermediates