Biopharmaceutical Services
Tepnel has specialist knowledge in the development, manufacturing and testing of biopharmaceuticals and can offer outsourcing solutions at all stages of the product development pipeline.
Our Approach & Services
Discovery support:
With extensive experience in the development of biologics we offer support for product characterisation and process development. We have the ability to generate monoclonal or polyclonal antibodies to customer-defined specificities which can be used in immunochemical tests.
Method Development:
- Full method development, feasibility and validation for NCE’s, pre-clinical and Phase I-III clinical trials.
- Biomarker identification, elucidation and anti-drug information
- Specialists in ELISA / ELISPOT development
Method Validation:
- Study plans based on current regulatory guidelines and latest recommendations for ligand-binding assays.
- Methods validated in accordance with ICH Q2 (R1) (CPMP/ICH/381/95 and addendum CPMP/ICH281/95) and the FDA Guidance for Industry on Bioanalytical Method Validation.
- The following validation parameters are routinely tested:
- Accuracy / Recovery
- Precision (Repeatability and Intermediate Precision)
- Calibration / Standard curve
- Specificity / Selectivity
- Quantitation / Detection Limit
- Linearity
- Range
- Stability of samples in matrix (including freeze-thaw, short and long-term stability)
- Stability of standard stock solution/s
Method Transfer:
- Where reliable and robust methods are in place we offer a rapid, quality assured method transfer service
Sample analysis:
- Sample analysis for a full range of sample types from drug substance to pre-clinical / clinical samples in mammalian species
- Experience in a wide variety of product types including recombinant proteins, monoclonal and polyclonal antibodies, vaccines, peptides and blood products.
- Expertise in protein analysis methods such as SDS-PAGE and Immunoblotting, Size Exclusion-, Reverse-Phase-, Ion-Exchange chromatography and LC-MS/MS and 20 years experience in custom ELISA/ELISPOT development and validation.
- Drug substance and batch release testing using USP, EP, JP, BP and client-supplied methods
- Clinical support from Phase I through to Bioequivalence
- High throughput sample analysis
- IT support using LIMS software ensures data integrity and facilitates fast turnaround of analysis and report preparation
- Efficient delivery of QA audited reports tailored to client / sponsor’s specification
Contact Us:
For further information please contact Chris Miller, Business Development Manager,
Mobile: 07920 118406
Email: cmiller@tepnelscientific.com
