Company profile
In 1996 Bactimm started as a production control laboratory for a manufacturer of sterile implantable medical devices Fame Holding. By acquiring Farmalyse in 2002, with more than 35 years experience in pharmaceutical chemical analyses, the companies extended the portfolio and developed into an internationally focussed contract laboratory.
Bactimm - Farmalyse is an independent Business Unit and operates as a limited liability company.
The laboratories are certified according the ISO 9001:2000, ISO 13485:2003 and received a GMP-GCLP and GLP (microbial validation) license for its analytical services.
Together with the Business Unit EMCM, Bactimm – Farmalyse are responsible for the contact services of the holding. EMCM (European Medical Contract Manufacturing) is the centre of excellence for developing and producing sterile medical devices. EMCM is certified according the ISO 9001:2000 and ISO 13485:2003 and received a Pharmaceutical License for the manufacturing of medicines and is FDA registered.
In 2007 Fame holding became part of aap Bio implants, listed on the German stock exchange.
aap Bio implants is an internationally operating medical device company active in developing, producing and marketing biomaterials and implants.
Business performance
Bactimm - Farmalyse
- 520 m2 high standard clean room facilities in which microbial testing is performed
- Certified quality system and long experience in testing products
- Many own developments focused on new technologies
- In total, 11 HPLC’s, one UPLC, three GC’s, and one state-of-the-art LC-DAD-MS from Agilent Technologies; a quadrupole MS type 1100 SL for both electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI)
- Attractive partner for companies that need to put their products on the EU market
Key figures
- Over 40 FTE work for the laboratories and more than 180 FTE for the holding company.
- Products: more than 500 products have been validated by Farmalyse/Bactimm with respect to analytical procedures – in total, about 1500 products are routinely analysed for n=100 clients
- Projects: numerous projects passed our hands – these range from simple analytical validations in conformity with ICH guidance to complete developments of NCE’s including IMPD and, in the end, preparation of an (E)DMF
- Patents: in the last 3 years, 7 patents were filed with regard to pharmaceutical formulation technologies, sterile filtration systems and medical devices
- Investments: about 15% of the annual turnover is used for investments