Particle engineering at Lonza


Particle engineering applications span oral, inhaled and transdermal drug delivery routes inclusive of:

  • Improve flow properties
  • Enhance dissolution rate and solubility of drug compounds
  • Improve the palatability of compounds (mouth feel)
  • Generate particles fine enough for effective nasal and lung delivery and absorption
  • Help ensure absorption of a drug across the skin

Particle size reduction technologies have an established track record and are highly flexible:

  • Easily applicable to different chemical properties
  • Good for substances with poor thermal stability
  • Ease of industrial scale-up
  • Cost-effective and well-known manufacturing process
  • High reproducibility (in dissolution terms) and size control

We provide customized and fit-for-purpose particle engineering as part of our integrated drug substance and drug product development services. Phase-appropriate particle size reduction processing, spray dryers or hot melt extrusion is in place to advance your compound from concept to clinical and commercialization. Particle size reduction to precise particle size distribution is in place across pin mill, hammer mill, jet mill and nano-mill processing at our Monteggio (CH) and Quakertown (US)) sites. Particle engineering services using spray drying or hot-melt extrusion is provided at our Bend (US) site.

Particle size reduction via micronization or nano-milling and amorphous solid dispersion technology via hot-melt extrusion or spray drying are often utilized to improve stability, flowability, dissolution rate and solubility. The choice of technology is dependent upon the API characteristics, target product profile and application. We have advanced thousands of molecules across a myriad of API parameters, applications and target product profiles. This experience has been used to develop technology selection methodologies incorporating models and reference maps over key formulation parameters.  This experience has also been utilized by our engineers to develop proprietary lab-scale processing that requires minimal amounts of API for feasibility assessments.  Our product development teams utilize these tools to rapidly select and employ the best particle engineering approach to address the problem statement(s) and meet the target product profile in a phase-appropriate manner.

Our product development teams are well versed in particle size reduction to low micron or sub-micron levels, as well as amorphous solid dispersion technologies. Specialized jet mill and spray dryer designs have resulted from decades of engineering study and provide optimized particle size distribution and performance.

We offer fully integrated product development from active pharmaceutical ingredients through particle-engineered intermediates to finished drug products. Our service packages include feasibility trials, robustness studies, design of experiment (DOE) in non-GMP and GMP environments, process development and optimization, analytical services, QC / QA, CMC and regulatory services.

Dedicated product development teams are in place for dry powder inhaler applications using either jet milling or spray dry processing.  Encapsulation for clinical trial materials and commercialization are in place to service your needs from concept to commercial.

We have invested in specialized processing to ensure that the needs of any compound can be addressed. High containment capability are in place so that mechanical, jet milling and spray drying can be safely conducted with highly potent API or cytotoxics. Before processing, every drug substance is evaluated by our HS&E team to determine the containment system required.

Specialized cryogenic milling is also in place for those friable compounds needing cooling due to low melting points or to avoid polymorphism.

small molecules and intermediates


particle engineering centers of excellence

We maintain Centers of Excellence for particle engineering services in the US and Europe. Specialized and phase-appropriate processing equipment is in place to support feasibility evaluations, clinical trials and commercial scale production of drug product intermediates for oral solid or inhaled delivery applications. Our particle engineering approach is matched to your specific molecule, application, target product profile, commercial objectives and phase of development. All sites have the capability to handle highly potent compounds from non-GMP feasibility work through to commercial scale manufacture.

Quakertown, PA

Production

20 Pacific Dr.
Quakertown, PA 18951
United States of America

Monteggio, Switzerland

Production, Research & Development, Sales & Support

Via Cantonale 4
Monteggio 6998
Switzerland

Bend, OR, USA

Production, Sales & Support, Research & Development

1201 NW Wall St.
Bend, OR 97703
United States of America