Farmalyse B.V.

Farmalyse B.V. Pieter Lieftinckweg 2 1505 HX Zaandam Website Farmalyse B.V. E-mail Farmalyse B.V. T +31 (0)75 612 36 66 F +31 (0)75 612 40 77 Employees in Amsterdam: 20 Employees in R&D: 5 Year of foundation: 1996

Company Profile

Science and Technologies or Services

Routine Pharmaceutical Chemical Analytical Services:

1. All tests are performed using validated equipment suitable for their intended purpose;
2. Farmalyse has extensive experience with many formulations – including non-standardised formulations;
3. Following tests are performed on large scale routine base:

•  Analysis of active ingredients according to E.P., USP, BP or JP;
• Assay of Organic Volatile impurities via head-space GC;
• Particle size analysis by means of laser diffraction;
• Dissolution tests of solid oral dosage forms;
• Stability testing performed in temperature/humidity controlled and monitored cabinets.

Routine Pharmaceutical Microbial Analytical Services:

1. All tests are performed in dedicated clean rooms suitable for their intended purpose;
2. Following tests are performed on large scale routine base:

• Bioburden, Sterility, Tests for Bacterial Endotoxins (LAL), total viable count, total spore forming bacteria;
• Tests for specified micro-organisms;
• Antiseptic and disinfectant activity testing;
• Challenge tests (Preservative Efficacy Tests);
• Biological assay of antibiotics.

Client specific report format via a Web-enabled On-line Laboratory Information Management System (LIMS) for direct sample entry by client and retrieval of analytical (trend) data by client.

Alliances

Feyecon BV: FORMULATION DEVELOPMENT

Using supercritical carbon dioxide (scCO2), Farmalyse, in cooperation with Feyecon BV, is able to encapsulate lipophilic API’s into hydrophilic carriers without the use of organic solvents. Dissolution and stability characteristics improve substantially using this fast and upscalable technique. Up to 40% of all new pharmaceutical compounds have a poor biological availability due to their low solubility. There are different strategies using a combination of supercritical fluid (SCF) technologies leading to preferred particle morphology and many co-precipitation possibilities. The Feyecon / Farmalyse cooperation provides support for drugs, from pre-development, through formulation development, to the filing of regulatory applications worldwide. The aim is to ensure that these formulations will deliver the drug to the correct biological sites in humans, to produce the necessary effects. Another important function of Farmalyse is developing stability testing protocols, to support the regulatory dossier.

Prisna BV: (Product Isolation from Nature) is a consortium of Farmalyse BV and several independent Dutch companies with Leiden University. We offer discovery, development and production of natural products, including extraction, separation, isolation, purification and structure elucidation or just fractionation of extracts.

PRISNA offers the following services to its clients: contract research, manufacturing of target compounds, equipment distribution/support, GLP, GMP compliant (on request) including prep. of DMF’s and IMPD’s

Technologies: supercritical extraction (scCO2), centrifugal partition chromatography (FCPC), preparative HPLC, Flash Chromatography, NMR, LC/MS/DAD, GC/MS, UPLC/DAD, Cytochrom P450 metabolomic studies, Isotope labelled plant material (C13, N15)

CONTRACT RESEARCH FOR THIRD PARTIES

The modern analytical equipment in the consortium is also available for third parties. The following table summarizes the equipment and their intended use:

Keywords

• Microbia
• Quality control
• Pharmaceutical
• Stability
• Formulation development
• Regulatory
• Consultancy