Regulatory compliance
BioAnaLab has developed a comprehensive Quality System which underpins all of its services whether intended for research and development, or for regulatory submissions. The system is designed to be compliant with relevant international guidelines for Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GLP). BioAnaLab is accredited by the UK MHRA as a full member of the GLP Compliance monitoring programme and an analytical laboratory to carry out studies in compliance with GMP. It has a full time independent QA Manager. The company actively encourages client audits of its facilities.
TK/PK Sample Analysis
Where toxicokinetic/pharmacokinetic analysis is required on biologics, these novel types of therapeutics require novel analytical approaches. BioAnalab's capabilities includes a range of ligand-binding formats (EIA, ELISA, RIA), flow cytometry , surface plasmon resonance (BIAcore), electrochemiluminescence, western blotting and cell-based assays.
Development of assays that are both specific and sensitive presents analytical challenges which BioAnaLab welcomes.
Immunogenicity/Antigenicity
Development of unwanted immunogenicity is a particular issue affecting therapeutic proteins. The development of anti-drug antibodies (ADA) can cause allergic or anaphylactic reactions, reduction in efficacy, or induction of autoimmunity. The risk of antibody formation is related to many factors including the production process, formulation and number of doses administered during the course of treatment.
Conversely, in the assessment of efficacy of vaccine products the development of an immune response is the desired result.
In both cases, BioAnaLab offers a service to quantify and characterise the nature of the response. Techniques employed include:
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ELISA/EIA |
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Radioimmunoprecipitation |
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Surface plasmon resonance (BIAcore) |
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Electrochemiluminescence (MSD) |
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Immunoblotting |
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Neutralising antibody assays |
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(including cell-based assays) |
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Opsonophagocytosis |
BioAnalab uses a stepwise approach to the assessment of antibody response in order to understand the nature of the response initiated by the therapeutic protein. The steps are as follows:
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Screening assay |
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Confirmatory assay |
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Neutralisation assay |
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Characterisation assays |
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(isotype, affinity etc) |
The development and validation of immunogenicity assays is under constant discussion within the industry. BioAnaLab is involved in international workshops and has an R & D programme underway to keep ahead of the latest developments in this area.
Biological Potency Assessment
The staff of BioAnalab have extensive experience in the development and validation of assays to assess the biological potency of biotherapeutics. These assays can be used in the following areas:
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Analyte quantitation for TK/PK purposes |
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Product efficacy for Batch release, |
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characterisation and stability testing |
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Neutralising antibody activity |
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Candidate selection |
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Metabolite activity |
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Pharmacodynamic and surrogate markers |
Due to their diverse nature, a wide variety of highly specific techniques are employed such as:
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In-vitro ligand binding assays |
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(e.g. EIA, ELISA, RIA, SPR) |
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Cell proliferation assays using radioactive |
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(3H-thymidine, 14C-leucine), colorimetric |
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(MTT, XTT, WST-1, etc...), and vital dye |
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(FACS) endpoints |
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Receptor binding assays |
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(radio-labelled and FACS) |
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Cell surface and intracellular antigen |
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expression (FACS) |
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In- vitro and ex-vivo receptor mediated |
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response |
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Opsonophagocytosis assays |
Depending on the nature of the assays, the data can be expressed as absolute values, as a ratio of ED50 values, relative to threshold limits or by parallel line determination.
In the cell based assays, BioAnaLab Ltd employ a number of strategies aimed at minimising the inherent variability often encountered when dealing with cell lines.
Assay Development
Where insufficient resource is available in house, BioAnaLab can assist in the development of new assays. Working in conjunction with your scientific staff we can utilise our experience and scientific knowledge in developing assays to meet your requirements.
The following are a list of typical stages in the development of an assay capable of being subjected to a thorough validation:
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Optimise assay conditions |
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Establish a mathematically definable |
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response |
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Verify assay range using precision profiles |
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Determine specificity |
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Determine intermediate precision |
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Analyse blind samples |
Assay Validation
The validation of analytical methods is crucial in generating data to be used in support of regulatory submissions.
BioAnaLab offers an assay validation service, which is tailored to meet your requirements and is appropriate for the clinical development phase and the nature of the assay.
The assay validation criteria typically assessed include:
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Accuracy |
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Precision (repeatability, intermediate |
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precision and reproducibility) |
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Limit of detection (LOD) |
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LimitS of quantitation (LLOQ, ULOQ) |
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Specificity |
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Linearity and range |
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Robustness |
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System suitability |
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Short-term stability |
Due to the nature of the assays some of these criteria may not be relevant and other critical aspects of the assay may need to be investigated such as:
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Cell passage number |
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Drift |
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Prozone (hook effects) |
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Matrix interference (e.g. haemolysed, |
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lipaemic, bilirubinaemic) |
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Parallelism |
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Edge effects |
Assistance with clinical trial design
Design of clinical trials for therapeutic proteins demands an in-depth knowledge of their structure/function relationships. From the expertise gained through the clinical development of CAMPATH®, we can help with advice on trial design, dosing schedules and sample collection time points.
Sample collection kits
At BioAnaLab Ltd we understand the importance of efficient sample collection. We can provide sample collection kits, including labels, sample collection guidelines and case report forms direct to clinical trial centres throughout the world. Using our approved couriers we can also arrange for collection and shipping of samples under controlled conditions.
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