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
DEVELOPING ACTIVE
PHARMACEUTICAL INGREDIENTS
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
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
You may also be interested in
QUALITY CONTROL FOR API
We support our three
production teams, primarily
with on-time analytics.
QUALITY CONTROL FOR PHARMACEUTICALS
We continuously adapt our analytical skills, technical expertise and quality standards to your requirements.
ABOUT US
We deliver the complete process from development through production to packaging of your medicines.