DEVELOPING ACTIVE
PHARMACEUTICAL INGREDIENTS

Developing
chemical processes
and analytics under
one roof

We offer a wide range of research and development services for active pharmaceutical ingredients.

We have a wealth of experience in synthesis.
We are well equipped for analytics, from standard methods through to NMR spectroscopy, mass
spectrometry and trace analysis.

In addition to traditional organic reactions,
we also use modern synthesis methods.
And we know our way around “green chemistry”.


Dr. Gerhard Nössner, Chemical Process Development

The right chemistry is key.

It goes without saying that employee safety and environmental protection are our top priorities.

Dr. Gerhard Nössner, Chemical Process Development

We involve our customers
right from the start.

This means being open about our limitations before we begin the project and offering solutions where possible.

Dr. Axel Huwe, Chemical Process Development


Dr. Axel Huwe, Chemical Process Development

Our core API
development services

  • Developing and optimizing
    chemical processes pursuant to
    current guidelines, e.g. ICH Q11, M7, etc.

  • Characterizing final products
    and intermediate steps in
    API synthesis. Identifying impurities
    including fate-of-impurity (FoI) studies

  • Feasibility studies:
    Developing innovative and
    eco-friendly processes

  • Optimizing volume
    yields and throughput times

  • Supporting direct API
    technology transfer
    from customers to our
    production facilities

  • Developing crystallizations
    to adjust particle
    size distributions (PSD)

  • Investigating crystallization
    behavior, solubility
    and polymorphism
    (Crystal16(R), XRPD, SEM,
    microscopy)


Dr. Thomas Lehmann, Analytical Development

Over the past 20 years,
we have developed and
qualified well over 900
reference standards.

This expertise allows us to be independent, something which makes us truly proud.

Dr. Thomas Lehmann, Analytical Development

We use various tools
to ensure robust and
efficient process qualification
during scale-up:

Design of
experiments

Simulation software
for technical
processes

PROCESS ANALYTICAL
TECHNOLOGY
(ReactIR(R), PVM(R),
Lasentec(R)

Reaction calorimetry,
RADEX (5 g)
and DSC (10 mg)

Laboratory
automation
– Mettler
– Optimax
– Labmax
– Systag
– Flexilab

MODERN
ANALYSIS METHODS
– GC-MS
– LC-MS (high resolution)
– NMR
– IR
– XRPD
– REM

We do not use
chlorinated solvents
(subject to limited exceptions).

We always check if green solvents can be used in our development steps.

Sven Stirnweiß, Process Development


Sven Stirnweiß, Process Development

Dr. Carsten Jagusch, Process Development

We have state-of-the art
tools for literature research
and patents.

We also have constant access to original citations.
This helps us to get creative when developing syntheses.

Dr. Carsten Jagusch, Process Development


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