Integrated API clinical trial material development and manufacturing services

 

Our extensive network of state-of-the-art lab and small-scale synthesis plants are fully equipped to exclusively develop and manufacture API for early and late stage clinical trials.  

We produce complex APIs and intermediates requiring multi-step synthetic processes from milligrams to tonnes in support of clinical trials from pre-clinical through to Phase III and launch. Global customers are provided services from our Visp CH and Nansha CN sites, both of which are fully equipped to support development work through to commercial scale production.    

Our project managers and chemical development service teams - comprised of small molecule product development, manufacturing support and analytical services – work collaboratively with customers to ensure that phase-appropriate clinical material requirements are met for drug programs.  We have more than 200 scientists (PhD, MSc and BSc level qualifications) supporting all aspects of drug substance development and clinical trial material manufacture.

Our R&D and kilo labs support process development, sample preparation for drug substances and intermediates for early stage clinical trials. Small scale and mid-scale plants are also in place which support early and later phase clinical trial production, as well as low-volume commercial quantities to batch quantities up to 150kg. Multiple reactors are in place to support an extensive range of chemical synthesis technologies including organometallic reactions, oxidations, reductions, highly reactive and hazardous chemicals, asymmetric reactions and reactions under special conditions. 

Particle engineering capabilities at lab and pilot scale are also available for particle size reduction and spray dry processing of drug substances as required to meet desired API characteristics and target drug product profiles.

We have supported more than 30% of recent launches for new drugs with breakthrough designations.

Download our Nansha site overview

Flexible development and cGMP assets to support your chemical synthesis from concept to commercial 


As part of our comprehensive product development for drug substances and intermediates, we provide phase-appropriate trial material for feasibility studies, early and late phase clinical trials. In addition to R&D and kilo-Lab capabilities in both our Visp (CH) and Nansha (CN) facilities (10-30L vessels), we have dedicated small-scale and launch-scale facilities to support early stage and late-stage clinical trial programs, respectively.

Specialized HPAPI R&D labs and small scale plants are based in Visp to support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads.

Our R&D pilot plants and small scale plants adhere to strict global quality standards and facilitate seamless technical transfer into our launch and commercial scale facilities. Our QA and regulatory services team provide all data, information and support required for the CMC portion of regulatory findings.


Small Scale Plant
Nansha
Small Scale Plant
Visp
Mid Scale Plant
Visp
Purpose Campaigns for projects in early clinical phase to low volume commercial API/Intermediates production Campaigns for projects in early clinical phase to low volume commercial API/Intermediates production Campaigns for projects in clinical phase to commercial API/Intermediates and HPAPI production
Equipment
  • 6 reactors (4x160lt / 2x250lt / HC and GL)
  • Filter units (2 centrifuges, 3 filter dryers ~0.1-0.3 m2)
  • 2 tray dryers
  • 10 reactors (250lt/HC (2), SS (2) and GL (6))
  • Filter units (3 centrifuges, 1 filter dryers ~0.2 m2)
  • 3 tray dryers
  • ~30 reactors (250lt/630lt/2500lt SS and GL)
  • Filter units (centrifuges, filter dryers ~0.2-2.0 m3
  • Different dryers (cone, spherical, tray)
Some Special Features
  • Low temperature (-80°)
  • Hydrogenation up to 10 bar
  • Simple standard installation for easy change over and cleaning
  • Low temperature (-80°)
  • Hydrogenation up to 16 bar
  • Carbonylation
  • Simple standard installation for easy change over and cleaning
  • Temperature range -80°C to 240°C
  • Hydrogenation up to 10 bar
  • Ozonolysis, HPLC, Lyo, TFE
  • ~120 isolated steps per year
OEL >1μg/m3 >10μg/m3 >100ng/m3
Quality Aspects GMP
ISO
FDA
Swissmedic
GMP
ISO
GMP
ISO
FDA
Swissmedic

Our plant network for small molecules - API, particle engineering and drug products - operates to stringent global quality standards and has an excellent regulatory inspection record inclusive of FDA, SwissMedic, MHRA and ANVISA.

Exclusive and tailored development programs and business models are utilized to meet the specific needs of our increasingly specialized customers.

View our webinar

HPAPI requirements for fully-integrated service offerings by M. Janssen and P. Kuenti

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