Schaffhausen, Switzerland Facility Overview

Complex Small Molecule Manufacturing

As a development, launch, and commercial supply site for APIs and lipids as well as activated PEGs, our cGMP facility in Schaffhausen (Switzerland) offers production capacities for custom synthesis from grams to tons. We are the world′s leading supplier of reduced folates and have more than 50 years of experience in pre-clinical to commercial supply. Our tailored approach enables our customers to move their products to market quickly and efficiently.

Chemistry Development Services

Specialized in lipids, PEGs, reduced folates and other APIs, our comprehensive chemistry development services include:

  • Route finding
  • Chemical feasibility studies
  • Process characterization
  • Process optimization and full development including QbD and DOE
  • Scale-up for kilo lab and commercial scale up to 60 L
  • Process Safety evaluation
  • Impurity characterization and synthesis

Analytical Services

We offer comprehensive analytical support for all our cGMP operations from raw material quality control (QC) to final product release.

  • Thorough chemical analytical testing
  • Identification of impurities and by-products
  • Microbio lab for bioburden and endotoxin testing
  • Development of analytical and microbiological methods
  • Method validation according to ICH Q7
  • Stability studies according to ICH Q7 with internal storage capacity
  • Direct support by our technical teams
  • SAP QM as integrated LIMS with automatic data transfer

General applicable methods

  • UPLC (UV/RI/ELSD/CAD/MSD)
  • GC/GC-MS/MALDI-TOF
  • DSC/TG
  • IR/UV/Optical rotation
  • Wet chemistry (Titrations)
  • CE/Ion Chromatography
  • TOC
  • Microbiological testing

Special methods

  • XRPD – differentiation of polymorphic forms
  • NMR – structure elucidation
  • SEC – Mw distribution

Manufacturing

Schaffhausen provides APIs and key intermediates (drug delivery compounds) out of state-of-the-art cGMP facilities for use in clinical trials and commercial product applications.

Equipment Overview

QTY Equipment Capacity Temp Range
11
Glass line reactors 250 – 630 L (nominal vol.) -40°C – 200°C
3
Hastelloy® reactors 250 – 630 L -20°C – 160°C
2 Hastelloy® centrifuges 800 mm (diameter) -25°C – 100°C
1
Inverted bag centrifuge 450 mm -10°C–100°C
1 Hastelloy® double cone dryer 750 L (300 L product) -30°C – 200°C
1 Titanium filter dryer 280 L -20°C – 135°C
2 VA Shelf dryers 1150 – 2050 L 25°C – 100°C
2 VA centrifuges 800 mm (diameter) -25°C – 100°C
1 VA filter dryer
250 L -10°C – 100°C
2 Mobile vacuum contact dryers 160 L (nominal value) 25°C – 80°C

 

Clean Rooms

  • 5 ISO-8 clean rooms for dispensing active materials

Other Features

  • Endotoxin controlled purified water system

Technologies

  • Aromatic chemistry
  • Protected amino acids
  • Esterification
  • Alkylation
  • Heterocyclic chemistry
  • Pressure reactions

 

  • Oxidation
  • Reduction
  • Chiral synthesis
  • Chiral resolution
  • Hydrogenation

Compliance, Regulatory & EHS

Schaffhausen complies with the quality systems and standards of Merck KGaA, Darmstadt, Germany and has been inspected regularly by various regulatory authorities including the FDA (USA) and our principal regulator, the Swissmedic (Switzerland). A dedicated team of experts ensures full regulatory support/documentation:

  • Global expertise in API registration
  • Intellectual Property (IP) and Freedom-to-Operate (FTO) evaluation
  • Proven track record of successful DMF submissions globally
    • Preparation of regulatory filings (NDAs)
    • 150+ customer audits over the past 10 years
  • Excellent FDA inspection track record (no Form 483 issued)
  • Quality systems cGMP/ICH Q7
  • Compliant with US-FDA generic drug user fee act (GDUFA)
  • Annual Kosher inspections
  • Annual Halal inspections
  • License for handling controlled substances

Dedicated Experts

Research & Development

Our team of dedicated scientists and highly skilled experts support the development of innovative APIs, activated PEGs, PEG-hydrogels and specialty lipids suitable for parenteral use. Our position as a large European manufacturer allows us to offer a full spectrum of services from reaction screening to commercial supply.

Project Management

From evaluation to execution, our dedicated project managers are coordinating multidisciplinary teams, international site activities and timelines throughout the lifecycle of your program.