Analytical services for (bio)pharmaceutical products and ATMPs, with a focus on hydrodynamic techniques such as SV-AUC and AF4.
ZentriForce Pharma Research GmbH
New on Amplifa
About ZentriForce Pharma
ZentriForce Pharma Research GmbH is a specialized service provider for the analytical characterization of (bio)pharmaceutical products and ATMPs. The company was founded as a service provider focusing on hydrodynamic techniques for biopharmaceutical development, with an emphasis on gene therapy products and biosimilarity studies. The portfolio includes analytical ultracentrifugation (SV-AUC), asymmetrical flow field-flow fractionation (AF4), dynamic and static light scattering (DLS/SLS), size exclusion chromatography with MALS detection (SEC/SEC-MALS), and micro differential scanning calorimetry (µ-DSC). Services offered include, among others, aggregate detection, particle size determination in the range of approximately 1 nm to 1 µm, temperature stability testing (Tm, Toneset, Tagg), interaction parameter determination, and method development, including DOE-supported formulation development. Projects are performed and supervised by scientists with experience in the theory and instrumentation of the respective analytical methods; Professor Stephen E. Harding of the NCMH Nottingham is named as scientific advisor. Through the ZentriForce Academy, the company is also actively engaged in advancing the theory of hydrodynamic techniques and in scientific training.
- Processes
- Analytical ultracentrifugation (AUC) / SV-AUC, Asymmetrical flow field-flow fractionation (AF4), Dynamic light scattering (DLS), Static light scattering (SLS), Size exclusion chromatography (SEC) / SEC-MALS, Multiangle laser light scattering (MALLS), Microcal differential scanning calorimetry (µ-DSC), Temperature stability testing (Tm, Toneset, Tagg by DLS and SLS)
- Materials
- (Bio)pharmaceutical products / biomolecules, Gene therapy products (DNA/RNA complexes, liposomal carrier systems, AAV, viruses), Peptides (from 1 kDa), Biosimilars, Analytical Ultracentrifugation (SV-AUC), Asymmetrical Flow Field-Flow Fractionation (AF4), Dynamic Light Scattering (DLS), SEC / SEC-MALS
- Certificates
- Laboratory quality system according to WHO guidelines (SOPs)
- Industries
- Biopharmaceutical industry, Gene therapy, Biosimilars, Peptide-based active ingredients, ATMP
- 01
Sample receipt and processing according to SOP
- 02
Method selection and method development
- 03
Analytical measurement (e.g. SV-AUC, AF4, DLS/SLS, SEC-MALS, µ-DSC)
- 04
Data integrity check
- 05
Data interpretation, report and recommendations
Sample Classes & Analytical Techniques
Analytical Ultracentrifugation (SV-AUC)
First-principles method used as the standard for aggregate analysis and for the characterization of biopharmaceutical samples.
Asymmetrical Flow Field-Flow Fractionation (AF4)
Orthogonal method to SEC and SV-AUC, used among other things for aggregate detection, MALLS characterization and particle size distributions.
Dynamic Light Scattering (DLS)
Rapid screening method for aggregate and particle detection in the measurement range of approximately 0.5 nm to 1 µm.
SEC / SEC-MALS
Widely used method for aggregate determination, also with MALS detection that can be retrofitted.
Micro Differential Scanning Calorimetry (µ-DSC)
Label-free thermodynamic analysis of biomolecules, among other things for biosimilarity comparisons via thermograms.
Temperature Stability Testing (Tm, Toneset, Tagg)
Determination of thermal stability via DLS/SLS temperature ramps as rapid formulation screening.
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Analytical ultracentrifugation (AUC) / SV-AUCTesting | – | – | – | – | (bio)pharmaceutical products, Gene therapy products, Biosimilars, Peptides |
| Asymmetrical flow field-flow fractionation (AF4)Testing | – | – | – | – | (bio)pharmaceutical products, Gene therapy products |
| Dynamic light scattering (DLS)Testing | – | – | – | – | (bio)pharmaceutical products |
| Static light scattering (SLS)Testing | – | – | – | – | (bio)pharmaceutical products |
| Size exclusion chromatography (SEC) / SEC-MALSTesting | – | – | – | – | (bio)pharmaceutical products |
| Multiangle laser light scattering (MALLS)Testing | – | – | – | – | (bio)pharmaceutical products |
| Microcal differential scanning calorimetry (µ-DSC)Testing | – | – | – | – | Biomolecules, (bio)pharmaceutical products |
| Temperature stability testing (Tm, Toneset, Tagg by DLS and SLS)Testing | – | – | – | – | (bio)pharmaceutical products |
| Aggregate detection (soluble aggregates)Testing | – | – | – | – | (bio)pharmaceutical products |
| Particle size determination (1 nm – 1 µm)Testing | – | – | – | – | (bio)pharmaceutical products |
| Interaction parameter determination (DOE-based formulation development)Testing | – | – | – | – | (bio)pharmaceutical products |
| Light obscuration (LO)Testing | – | – | – | – | (bio)pharmaceutical products |
| Micro flow imaging (MFI)Testing | – | – | – | – | (bio)pharmaceutical products |
| Analytical method development and consultationEngineering | – | – | – | – | (bio)pharmaceutical products |
Additional services
Quality
ZentriForce Pharma operates a laboratory quality system based on the WHO guidelines following the principle “write down what you do, and do what you have written down”, with nearly 30 SOPs covering processes, equipment and analyses. Regular data integrity checks and a comprehensive training program for employees ensure traceability and reliability of results.
| Evidence | Company |
|---|---|
| Laboratory quality system according to WHO guidelines (SOPs) |