Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a system to ensure that medicinal products
intended for human use are consistently produced and controlled according
to appropriate quality standards. Swiss manufacturers of medicinal products
must comply with international GMP standards set forth by the European Union
(EU). These GMP standards are built on three pillars: 1) Pharmaceutical substances
and products intended for human use are to be manufactured in sites that are
adequately equipped, 2) the producer has to demonstrate appropriate professional
and technical knowledge that is provided by qualified staff, and 3) a pharmaceutical
Quality Assurance system needs to be established by the manufacturer.

The DBM has obtained an permit from Swissmedic in March 2015 to operate such
a manufacturing laboratory. Headed by Werner Krenger, PhD, the “GMP core facility”
is located on the 4th floor of the ZLF and offers as “Provider” central services to
individual DBM research groups (“Users) that permit the manufacture of investigational
medicinal products (IMPs) to be used in clinical trials. A delimitation agreement
between Provider and User regulates activities and responsibilities. The final
product is released for clinical use by the the head of the core facility.

Affiliation and Staff
Both the core facility provider and the DBM research group users are required to
contribute to the implementation of a fully functional Quality Assurance (QA)-system
necessary for the release of GMP-compliant medicinal products: A QA-team
is provided by the GMP core facility DBM and includes the “Qualified Person” (W.
Krenger) with his deputy PD Dr. Paul Zajac, the “QA manager” Anke Wixmerten; and
an external quality assurance consulting firm “Quality Assurance Consulting AG;
QAC). The second team needs to be provided by the DBM research groups and
includes at minimum a “Quality Control Manager” (QC), a “Manufacturing Manager”
(MM) and a “Product Manager” (PM; which is usually the principal investigator
of a research group). Together, the teams establish the relevant documentation
required for implementation of an appropriate production process. Training of
all staff (both core facility staff and research group staff) is organized by the core
facility staff.

The laboratory, including its supporting utilities (computerized GMP monitoring
system) and the equipment (incubators, fridges, freezers, centrifuges, air sampler)
have been qualified in accordance with the requirements of GMP.

Since its inception in March 2015, two DBM research groups have used the core
facility services to produce different IMPs (cartilage tissue and genetically engineered
vaccinia virus; Fig. 2) to be used in two clinical trials. The facility offers,
however, the capacity for including additional teams. The DBM hopes that the
availability of this core facility will further stimulate the transition of preclinical research
into the study of exciting new investigational medicinal products.