Need a partner that can rapidly develop and manufacture your active pharmaceutical ingredients and intermediates from concept to commercial?
Contact Us

Customized API development and manufacturing services


We are an industry-leading integrated development and manufacturing service provider for small molecule drug substances and their intermediates.

Chemistry is core to us. Our track record in producing API and intermediates extends back to the genesis of contract development and manufacturing. Thousands of compounds have been successfully developed and progressed by our R&D, process development and manufacturing teams. Many of these molecules have been scaled under accelerated timelines to meet program objectives. 

We recognize that chemical synthesis accounts for the majority of the drugs on the market today, as well as in the drug development pipeline. And we recognize that today’s drug compound candidates are increasingly complex and can require specialized handling and protocols. That’s why we offer flexible development and manufacturing services across a wide range of chemical synthesis.

We also appreciate that every drug program is different and our customers require more agility and adaptiveness than ever before. We continue to meet this challenge through our investments in world-class infrastructure, technologies and teams to support your small molecule needs from proof of concept through commercialization.


LPB-A.06_SmallMoleculeTimeline (1)
Lonza Small Molecule Capabilities: Drug Substance to Drug Product, Parenteral to Oral

Introduction to Small Molecules

On-demand webinar

Extensive and flexible manufacturing services


We have an established history and ongoing service programs with the full range of customers from virtual companies to big pharma. Our development and manufacturing services routinely support:

  • drug substances requiring advanced synthesis expertise and process development
  • late phase clinical programs requiring the scale and expertise provided by Lonza for rapid commercialization
  • highly potent compounds requiring our specialized infrastructure and handling capabilities
  • ADC payloads with the option of integrated services inclusive of monoclonal antibodies, inkers and conjugation services.  

Phase-appropriate assets support all phases of drug substance development and supply.

Fully integrated services are in place to meet all of the development and manufacturing needs for drug substances and intermediates:


service
Regulatory Affairs Services
Our Regulatory Affairs Services provides an extensive CMC writing and procedural offering to clients. We use our hands-on practical experience from early development through clinical programs (IND & IMPD), support for preparation and approval of license a...
service
Analytical Services
Analytical development and validation services supported by experienced analytical scientists and state-of-the-art equipment are integral to any drug development program. At Lonza, we provide thorough analytical support, candidate screening, drug product...
service
API Research & Development Services
We provide full development services for small molecules across a range of standard and advanced chemical synthesis routes.
service
API Clinical Trial Material Manufacturing Services
We provide exclusive chemical synthesis services for early and late stage clinical trial material.
service
API Commercial Production Services
We provide premier commercial-scale production services for APIs and their intermediates.
service
HPAPI Product Handling
We have specific capabilities, infrastructure and expertise in handling highly potent API (HPAPI) compounds.
service
ADC Payload Product Development
We can provide a full-service offering for antibody-drug conjugates (ADC) inclusive of ADC payloads, monoclonal antibodies, linkers and bioconjugation services.
service
Particle Engineering Services
Particle engineering is increasingly required to prepare active pharmaceutical ingredients for effective drug product formulation for oral solid and inhaled applications.
service
BA Enhancement
The depth of our bioavailability enhancement offering makes us a leader in addressing drug solubility and dissolution rate issues.
service
SimpliFiH® Solutions: First-in-Human Services
We can provide integrated drug substance and drug product services for preclinical studies and phase I clinical trials.
service
SimpliFiH® Solutions: First-in-Human Services
We can provide integrated drug substance and drug product services for preclinical studies and phase I clinical trials.
service
API Commercial Production Services
We provide premier commercial-scale production services for APIs and their intermediates.

Technologies and products

technology
Chemical Synthesis Technologies
We master an extensive array of chemical platforms and technologies.
technology
Hot Melt Extrusion
Hot-melt extrusion (HME) technology is an established solid dispersion technology for improving dissolution rate and solubility, and a component of our premier bioavailability enhancement services.
technology
Micro-dosing for Powder-in-Capsule / Powder-in-Bottle Studies
Micro-dosing is the process of dispensing a precise amount of drug substance into a capsule (or other container, e.g. vial or bottle), for use in early phase human studies (phase I safety evaluations). This powder-in-capsule (PIC) or powder-in-bottle (PI...
technology
Micronization & Jet Milling
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 siz...
technology
Spray Drying Technology
Pioneered for pharmaceutical applications by Bend Research (now Lonza), spray drying has emerged as a primary technology for addressing poor dissolution rate, solubility and bioavailability.
We have supported more than 30% of recent small molecule launches with breakthrough designations.

small molecules and intermediates

World class, extensive infrastructure is also in place at our Visp, Switzerland and Nansha, China facilities to ensure fit-for-purpose supply to a global customer base. Phase-appropriate assets support all phases of drug substance development, and a focus on manufacturability ensures that our processes are rapidly scalable.

Visp, Switzerland

Production, Research & Development, Sales & Support

Visp 3930
Switzerland

Nansha, China

Production, Research & Development

Huangge N Ave
Guangzhou, Nansha 511455
China