amaxa news #10 - Lonza AG

› amaxa Insights
Dr. Rainer Hammermann
Head of QA
The amaxa QA
and Production Team
The Scientific Support department will be involved in monitoring
and following up with statistics to show improvements made by
the new production process and Dr. Rainer Hammermann, Head of
QA, ensures that each piece of customer feedback is recorded and
that each individual complaint is followed up to the customer’s
satisfaction. “Scientific Support is a very important channel for
monitoring both emerging customer needs and also customers’
perception and acceptance of amaxa quality standards. We are not
standing still – instead we are anticipating our customers needs for
the next five years and beginning projects that will help to further
associate the name amaxa with high quality and dependable
products.”
amaxa cGMP Kits (current Good Manufacturing Practice) and their
components are manufactured and filled under Grade A clean
room conditions (EU Guide to Good Manufacturing Practice-
Manufacture of Sterile Medicinal Products, 1997), meaning that
air in the manufacturing facility is monitored and that each
cubic meter of air contains not more than 3500 particles of
0.5 µm diameter or larger. Manufacturing each kit component
in full compliance with cGMP regulations means that these kits are
suitable for use in disease research and development of
pharmaceuticals. Scientists working in heavily regulated areas
such as protein production and drug discovery can now use amaxa
› Page 19 › www.amaxa.com
cGMP Kits for their work without first validating
kit performance and other features. In contrast
to other manufacturers, amaxa includes a
more detailed and batch-specific Certificate of
Analysis (CoA) into each cGMP Nucleofector ® Kit,
providing an ‘audit trail’ of performance and
QA test data for each batch of kits. Rainer believes
that this demonstrates “full disclosure of
data in order to ensure reliable research results,
thus protecting the safety of researchers in
development departments of the pharmaceutical
industry.”
As the needs of Nucleofector ® users evolve and
expand into new application areas such as stem
cell research and drug discovery, amaxa Production
and Quality Assurance will continue to set
industry standards and enable researchers to be
increasingly confident in their research data.