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Berlin-Brandenburg at BIO 2024

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Campus <strong>Berlin</strong>-Buch GmbH<br />

CPL Sachse GmbH<br />

Interaction of Research, Clinics and<br />

Companies<br />

<strong>Berlin</strong>-Buch is the loc<strong>at</strong>ion of one of the<br />

largest biotechnology parks in Germany, with<br />

45,000 square meters of scalable lab and<br />

office space for start-ups and companies.<br />

Situ<strong>at</strong>ed to the northeast of the city, the<br />

Campus <strong>Berlin</strong>-Buch is currently home to<br />

78 companies, 57 of which are biotech<br />

companies; the rest provides support<br />

services. Part of the Campus community<br />

are the Max Delbrück Center for Molecular<br />

Medicine, the Leibniz Institute for Molecular<br />

Pharmacology, as well as clinical groups<br />

from the Charité University Medicine <strong>Berlin</strong><br />

and the <strong>Berlin</strong> Institute of Health.<br />

dedic<strong>at</strong>ed to health<br />

CPL Sachse produces APIs for human<br />

and veterinary use.<br />

We manufacture APIs under cGMP for (pre-)<br />

clinical development and market supply up<br />

to ≤ 50 kg scale. The company has been<br />

successfully inspected multiple times by<br />

EMA (LaGeSo) and FDA.<br />

The following compounds are available<br />

from us under a GMP certific<strong>at</strong>e from our<br />

local authority: Anagrelide, Atipamezole,<br />

Clenbuterol (CEP), Detomidine (CEP),<br />

Medetomidine, Methacetin( 13 C), Nabilone<br />

and Phenoxybenzamine. Further APIs as<br />

well as reference standards for APIs and<br />

impurities are available on request.<br />

Moreover, we carry our route scouting for<br />

NCEs and develop and valid<strong>at</strong>e processes<br />

as well as analytical methods required to<br />

test the APIs and the subsequent drug<br />

products. Furthermore, we offer stability<br />

tests according to ICH guidelines.<br />

Finally, we offer all regul<strong>at</strong>ory services<br />

required for the prepar<strong>at</strong>ion and submission<br />

of a pharmaceutical dossier (for APIs and<br />

drug products).<br />

SMART API ® CHEMISTRY + DEVELOPMENT<br />

Campus <strong>Berlin</strong>-Buch GmbH<br />

Robert-Rössle-Str. 10<br />

13125 <strong>Berlin</strong> | Germany<br />

Dr. Christina Quensel<br />

Tel. +49 30 9489 2511<br />

office@campusberlinbuch.de<br />

www.campusberlinbuch.de<br />

Chemisch-pharmazeutisches Labor,<br />

Rolf Sachse GmbH<br />

Stiefring 14<br />

13627 <strong>Berlin</strong> | Germany<br />

Dr. Michael Sefkow<br />

Tel. +49 173 373 2260<br />

michael.sefkow@cpl-sachse.de<br />

www.cpl-sachse.de

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