 |
|
|
PharmaSol Facilities
|
GMP Facilities
|
Top
|
|
Production under GMP conditions is possible via the cooperation partners of PharmaSol:
Dr. Rimpler GmbH
Neue Wiesen 10
30900 Wedemark
Germany
Phone: +49 (0) 5130 7929-0
Fax: +49 (0) 5130 1755
Dr. Rimpler GmbH is a well established producer of topical formulations. Production facilities
with homogenisers are available and they comply with pharmaceutical GMP standards, thus allowing the
production of particle suspensions for dermal and oral administration.
|
The above left picture shows a clinical batch production unit based on an Lab60. The production unit was
developed to produce clinical batches for the first human study of
orally administered lipid particles. One unit is available at PharmaSol,
and another is available in a GMP area at a pharmaceutical company.
ProBioGen AG
Goethestraße 54
13086 Berlin
Germany
ProBioGen has "roll in-roll out" GMP facilities available for processing their cell
culture systems, including biotechnology drugs. Sterile processing is also possible. These facilities
can also be used to produce parenteral batches on lab scale.
Production of clinical batches of up to 20 l for parenteral administration can be done by PharmaSol on request (after signing of CDA).
|
High Security Facilities
|
Top
|
For processing highly potent drugs (e.g. proteins, hormones) or cytotoxic compounds for cancer
treatment, enclosed homogenisers are required. PharmaSol has a Micron Lab40 unit
contained within a laminar air flow cabinet and this allows highly potent and toxic compounds to be processed.
The homogenising unit can be sterilised and thus also provides a suitable facility for the aseptic production of sterile particle suspensions.
|
Micron Lab40 homogenisation tower contained within a
laminar air flow cabinet in a high security production unit.
|
Lab scale production
|
Top
|
Micron Lab 40 high pressure homogeniser for the production of 40 ml lab batches
|
PharmaSol produces its nanoparticles by high pressure homogenisation. A batch size ranges
from as small as 3.5 ml particle suspension (which is beneficial in cases where there is a limited drug supply e.g. NCE)
to a standard lab batch size 40 ml suspension. PharmaSol´s standard homogeniser for this batch size
is the Micron Lab40 (APV Homogeniser Systems, Unna, Germany). By using the continuous version of the Lab40,
lab batch sizes of 200-500 ml can be produced.
|
Large scale production
|
Top
|
PharmaSol has a Gaulin 5.5 homogeniser with a homogenisation capacity of 150 l/h.
The unit is presently equipped with product containers with a 50 l volume. This allows the production
of a 50 kg lipid nanoparticle dispersion within 20-40 minutes. Larger batch sizes could be produced
on request by using larger product containers or static blender systems.
|
On the left :
Gaulin 5.5 homogeniser, pharma grade material, homogenisation capacity: 150 l/h
On the right :
Product container, volume 50 l, pharma grade material, temperature controlled, protected hive
gassing applicable, cleaning in place (CIP) and sterilisation in place (SIP).
|
