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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
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Company Profile
Together with EMCM and Bactimm, Farmalyse is a Centre of Excellence in the manufacturing and testing of Sterile Medical Implants and Pharmaceuticals. Certification according to the ISO9001: 2000, GMP-GCLP and ISO13485:2003 guidance, additionally EMCM received a Pharmaceutical License for the manufacturing of medicines and is FDA registered. At Farmalyse 10 HPLC’s consisting of 8 standard HPLC’s, one UPLC 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) are situated. A certified quality system and long experience in working with many generic products. Farmalyse is an attractive partner for companies that need to put their products on the EU market.
Science and Technologies or Services
Routine Pharmaceutical Chemical Analytical Services:
- All tests are performed using validated equipment suitable for their intended purpose;
- Farmalyse has extensive experience with many formulations – including non-standardised formulations;
- 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:
- All tests are performed in dedicated clean rooms suitable for their intended purpose;
- 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:
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Equipment
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Use
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GMP CO2 unit
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Extraction and formulation development + extraction of high value compounds in natural products such as nutraceuticals, cosmetics and pharmaceuticals
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Overpress. water extraction
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Extraction of plant material
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LC-DAD & densitometry (TLC)
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Analysis of complex plant extracts
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Centrifugal Partitioning Chrom.
Nutraceutical
Fine chemical
Pharmaceutical
Bio-medical
Biotechnology
Fats and oils
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Pharmaceutical raw materials + impurities
ultra-pure compounds can be created from natural products
innovative new products can be developed
higher yields can be achieved
product development is faster and less expensive
integrity of the material's bioactivity is maintained
higher throughput is achieved
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Agilent 1100 LC-MSD, type SL
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Residue analysis of pesticides, antibiotics etc (for instance in MRL studies);
Peak purity analysis (pharmaceutical development);
Pharmacokinetic analysis (PK studies).
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Keywords
- Microbia
- Quality control
- Pharmaceutical
- Stability
- Formulation development
- Regulatory
- Consultancy
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