Drug Product Formulation and Development

Trusted Experts

We are one team of connected experts (>50 SMEs) you can trust to deliver. We can help you solve your molecule's challenge at speed to keep it on track for success.

Tech Selection

Our technology selection is based on models, reference maps of critical parameters and an extensive database developed from study and in-house advancement of thousands of molecules.

Increase your Chance of Success

Working with us gives you flexible phase-appropriate approaches to advance your molecules journey. With our dedicated in-house CMC and RA support, you can increase your chance of success.

Product design expertise

Our product development teams are equipped to meet all your formulation and product development needs in a phase-appropriate manner, including:

API characterization and problem statement definition
Technology selection for best formulation options
Addressing bioavailability or dissolution rate issues
Profiling and modulating pharmacokinetics
Developing a formulation strategy and requirements
Developing and manufacturing phase-appropriate clinical material
Developing and validating processing and analytical methods
Regulatory preparation services including generating and documenting all required data for clinical trial filings

Formulation expertise

We have broad capabilities across the full range of formulation problem statements with premier expertise in:

Bioavailability, solubility and dissolution rate issues
Modulation of pharmacokinetics using specialized targeted and modified release technologies to meet the needs of your TPP
Low dosing / HPAPI processing and formulations

Benefit from access to our data and experience-driven approach, selecting from a full range of enabling technologies to address the above and other problem statements. Proprietary technologies and processing have been developed to optimize formulation performance. Manufacturability and QbD principles are built into formulation design and strategy to ensure no re-work is required for a scalable solution.

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

Solid dispersions
Multiparticulates
Particle size reduction
Fixed-dose combinations
Engineered particles for inhaled applications
Modified- and targeted-release formulations
Sterile fill and finish for parenteral applications

By partnering with an integrated provider, there’s a convenience factor, a speed factor and a benefit in the regulatory environment.

David Lyon, Senior Fellow Research, Lonza

Meet Deanna Mudie

Principal Scientist in Research and Development

Bend, Oregon, USA

Deanna Mudie is a Principal Scientist in Research and Development at Lonza’s site in Bend, Oregon, USA. Since she joined Lonza in 2016, her focus has been on enabling bioavailability-enhancing amorphous solid dispersions by developing dosage form platforms and in vitro dissolution methodologies to predict bioperformance.

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Our locations

Global, high-quality facilities that bring your molecule to life

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Monteggio, Switzerland

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Regulatory expertise

Pathway to success in Regulatory filings

Extensive Regulatory Expertise

We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.

Dedicated Regulatory Affairs Contact

We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.

Keep Pace with Regulatory Thinking

Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.

Small Molecules