DANNALAB B.V. is a contract research organization (CRO) dedicated to the X-Ray study of pharmaceuticals and biopharmaceuticals, using X-Ray Powder Diffraction (XRD, also known as XRPD and Small Angle X-Ray Scattering (SAXS) techniques.
DANNALAB expertise extends from analytics for pre-formulation, formulation and stability testing through to quality control during the batch manufacturing of drug product.
The company is proud to offer fast and affordable cGMP analytical services to industry-leading performance standards with advanced capabilities in method development and validation. The company’s expertise is enhanced by close cooperation with leading analytical equipment manufacturer Malvern-PANalytical.
Through XRD characterization, DANNALAB helps customers to control polymorphism and impurities in drug substance, intermediates and finished drug products. An important additional service is the analysis of pharmaceutical patents often containing XRD data in claims and specifications. This helps to ensure the drug product does not infringe existing IP.
For innovative pharmaceuticals, such as biologics, SAXS characterization can define the tertiary structure and oligomeric state of biopolymers in their natural environment. For biosimilars, SAXS characterization is used to confirm identity to the original. SAXS is often used to investigate stability of drug product over time, including nonambient environments. A further important area of application of SAXS is the investigation of innovative drug delivery vehicles. In this field DANNALAB offers a cGMP SAXS characterization of internal structure, dimensions and topology that is so far unique within regulated service providers.
DANNALAB contract services are built around expertise and capabilities in use of cGMP XRD and SAXS for R&D, formulation and batch release.
Service offers include:
- Qualitative and quantitative XRD control of polymorphism including fast analytical support during the batch release
- Analysis of XRD-related patent claims and specifications
- Structural analysis of drug products and drug delivery systems using SAXS
- Custom method development for routine QC or for non-trivial analytical needs
DANNALAB contributed to multiple patents related to new methodologies and solutions, all owned by Malvern-Panalytical. These include:
- Methodology for the correction of instrumental aberrations in XRD (US7516031)
- XRD methodology to identify counterfeit pharmaceuticals (US7756248)
- System with combined XRD-SAXS capabilities (US7542547)
DANNALAB expertise has also contributed to the development of commercial software, notably Malvern PANalytical’s EasySAXS for analysis of small-angle X-ray scattering data.
Access to advanced technologies has enabled DANNALAB to develop and validate new analytical methods.
Company history and structure
DANNALAB was founded in 2001 by Dr. Vladimir A. Kogan, who is its CEO and Scientific Director. His fellow principal board member is Dr. I van Nugteren. She is QA manager and Qualified Person for quality certification purposes.
In 2007, the company moved to its current facilities in the city of Enschede in the eastern Netherlands. In the same year DANNALAB expanded its services from X-Ray Powder Diffraction to Small Angle X-Ray Scattering.
Quality, Regulatory and Standards
DANNALAB has held Good Manufacturing Practice compliance (cGMP) certification since 2014 and also holds pharmaceutical testing laboratory and pharmaceutical manufacturer certification.
The company is validated by the Joint Research Centre of the European Commission for SAXS characterization of nanoparticles. It has conducted multiple studies for JRC EU devoted to creation of European standard reference materials (ERM-FD100 and ERM-FD102).
All XRD studies are conducted in accordance with guidelines defined by the chapters of pharmacopeias: EU. Pharm 2.9.33 and USP 941. For method development and validation, DANNALAB follows ICH Q2B and ICH Q3 guidelines.
All DANNALAB processes and projects are controlled by quality assurance according to GMP rules.
Data registration complies with CFR21 part 11, with samples stored in archive for the stipulated 5-10 years.
To date, all DANNALAB reports have received regulatory approval.
To learn more about DANNALAB B.V. services and capabilities and how they can assist your business, please contact the supplier:
- CRO, CMO, CRAMS & CDMO
- Drug Delivery
- Formulation & Ingredients
- Laboratory Equipment & Services
- Manufacturing & Production