Center of excellence for particle size reduction services

Lonza Quakertown serves as our US Center of Excellence for particle size reduction and control services for biopharmaceutical drug substances and excipients. The Quakertown site - and its European equivalent in Monteggio CH - is an integral component of our drug product design, development and manufacturing services network. Particle size reduction through micronization is a core strength of Lonza, and a key component of our integrated product development services across drug substances and finished oral solid and inhaled drug products.  Particle size reduction and control services are provided across the development cycle, supporting feasibility studies, clinical studies and commercial manufacture.

Stability, flowability, dissolution rate and bioavailability are all critical formulation parameters impacted by drug substance and excipient particle size distribution.    We are well versed in particle size reduction to low-micron and sub-micron level, which can be critical in meeting target product profiles.  Our product development teams utilize specialized and phase-appropriate jet and other mills to ensure robust process development and rapid scale-up.

Decades of precise particle size reduction experience across 1000+ compounds

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Pushing the Boundaries of Micronization in Drug Delivery

Particle engineering for optimizing drug performance

Lonza Quakertown provides particle engineering and control services for a global customer base ranging from non-GMP feasibility studies to ongoing commercial supply. The Quakertown operation is FDA-registered and a full service provider for drug programs across process and analytical development and validation, quality control and regulatory support.  As part of our integrated service offer, Lonza can also can also develop and manufactured both drug substances and finish drug products for oral, pulmonary and parenteral delivery.

The Quakertown site is equipped with phase-appropriate and scale-appropriate milling for biopharmaceutical excipients and drug substances. The choice of equipment is dependent upon the material, target product profile and application.

Milling technology Particle distribution Benefits
Hammer milling Several hundred microns For hard, difficult to grind materials
Pin milling 100 – 400 microns Free flow powders
Jet milling 1 – 10 microns Superior consistency
Nano milling Nano-scale particles Special use cases

This full range of milling technologies, inclusive of 25 jet mills for both non-GMP and GMP production, provides more than 1000 MT total capacity.

  • 10 cGMP suites with independent air handling units, HEPA filtration, temperature and humidity controls
  • Dedicated non-GMP suite for feasibility and development
  • Phase-appropriate equipment for all stages of particle size reduction

Our processing suites provide commercial scale milling with ample space for single step or multiple step (milling/classification) unit operations. The developmental suite is used both to evaluate new products and to process small scale batches for clinical trials or R&D use. With low system loss, the pilot equipment is an ideal choice for high value pharmaceuticals where yield is critical.

Lonza Monteggio (CH) offers equivalent capabilities and services to Lonza Quakertown, and serves as our European Center of Excellence for particle size reduction services.  These complementary sites have a combined 65 years’ particle engineering experience, and share best practices in process optimization, mill design and operation. Regulatory registrations / inspections across these sites include: US FDA; SwissMedic; Japan Ministry of Health, Labor & Welfare; Korea FDA, Australian Dept. of Health

Specialized capabilities for HPAPI processing

As part of our integrated HPAPI product development services, we provide high containment capabilities for highly potent or cytotoxic compounds, utilizing a universal milling isolator to serve as primary containment. Verified processing procedures demonstrate our ability to safely handle compounds and provide OEL’s of 10ng/m3 from low gram scale to early stage commercial production. HPAPI services also include specialized finished drug product development and manufacturing, inclusive of soft gels, liquid-filled hard capsules and sterile fill / finish for parenteral applications.

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Particle size reduction is increasingly utilized to address a range of formulation issues facing oral solid and inhaled dosage forms. Stability, flowability, dissolution rate and bioavailability are critical performance parameters impacted by particle size distribution. Micronization through jet milling is a core strength of ours with unparalleled expertise, track record and capacity in place to meet these challenges.
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