Need one partner to meet your API development needs?
Contact Us

overhead view of gloved hand

Research and Development

 

We offer a broad spectrum of research and development services for small molecule APIs using state-of-the-art chemical technologies. To achieve robust and efficient process qualification for scale-up, our API development process utilizes modern tools such as automated workstations, statistical software, and reaction calorimetry.

  • Evaluation and API route scouting for early phase or potential projects
  • Process development and technology transfer for small molecule APIs in early phase
  • Development and optimization of chemical processes
  • Kilo-lab and small scale production under ISO or cGMP standards
  • Process optimization via simulation
  • Analytical and testing services including identification of impurities and characterization of API products and intermediates

We provide cost-competitive manufacturing on an industrial scale by optimizing chemical processes, utilizing advanced PAT and minimizing unit operations, supported by specialized quality control and quality assurance expertise.

 

We focus on customer technology, regulatory and development API needs, to deliver:

  • Feasibility studies which include: development of innovative processes and 2nd generation processes (1-3 months)
  • Small scale quantities (10–100 kg, 3–10 chemical steps; APIs) (2-3 months)
  • Process development production of launch quantities (100 kg –5 tons), full regulatory support, validated processes (APIs, HPAPIs) (3-6 months)
  • Support of direct API technology transfers from clients to our industrial plants (1-3 months)
This peer-reviewed publication describes a method for developing intensified and dedicated pharmaceutical processes, known as mini-monoplants. Key value-generating aspects are described at each stage of development, from lab-based development of best-in-class processes to factory-based development for an accelerated time to market and finally to mini-monoplant technology for production at commercial scale.

View our peer-reviewed publication

Mini-Monoplant Technology for Pharmaceutical Manufacturing

Development and Optimization of Chemical Processes

 

Our API R&D and manufacturing teams have experience in many types of advanced chemical synthesis techniques. We are always prepared to adopt and optimize your process or offer you many advanced techniques of our own. In either case, our team can provide you with successful development technologies for all of your chemical processing needs.


Our Advanced Chemical Synthesis Technologies Include:

Technology Example
Hazardous and Highly Reactive Chemicals HCN, ClCN, chlorosulfonyl isocyanate, SOCl2,
Cl2 (gas/liquid), ketene, diketene, phosgene
(cGMP), CO, acetylene, ethylene
Organometallic Reactions Grignard, organolithium, sodium in liquid
NH3, organozinc reactions, Heck reactions,
Suzuki cross-couplings
Reductions Catalytic hydrogenation (homogeneous and
heterogeneous), metal hydrides (NaBH4, LiAIH4),
Raney nickel
Oxidations With ozone (batch and continuous), peroxides,
oxygen/air, nitric acid, ammoxidation
Reactions Under Special Conditions

Low-temperature reactions (-90°C)
High-temperature reactions (+250°C)
High-pressure reactions (10–100 bar)
Asymmetric Reactions Transition metal catalysts
(hydrogenation, oxidation, Heck/Aldol),
biocatalysts, racemic separation,
use of chiral building blocks

 

related content

Lonza Nansha, China for Global Excellence in Advanced Chemical Synthesis
Tech brief
Particle-Size Engineering Through Micronization
Tech brief
Lonza Small Molecule Capabilities: Drug Substance to Drug Product, Parenteral to Oral
Webinar on-demand
Solid Form Services
Tech brief