Biopharmaceutical Services

We have specialist knowledge in the development, manufacture 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

Gen-Probe Life Sciences Ltd.
Tepnel Pharmaceutical Services
Appleton Place
Appleton Parkway
Livingston
West Lothian. EH54 7EZ
Tel: +44 (0)1506 424270
Email: pharmaservices@gen-probe.com