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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Data gap analysis

In order for a regulatory dossier to be approved (MAA or BLA) it essential that there is enough data to provide assurance of product quality. Thus, the assurance of product quality will be a key component of data gap analysis. BioVentures Consulting Limited has significant expertise in conducting a detailed data gap analysis for clients. This may be part of an in-licensing due diligence process, or as part of the in-house assessment of the proposed registration dossier. Areas which BioVentures Consulting Limited can focus on include an assessment of the pharmaceutical development; and the analytical specifications, method validation and stability specifications for both drug substance and drug product.

BioVentures Consulting Limited has a core competence in the strength of its scientific and technical expertise. This expertise is invaluable in pharmaceutical development work, which is underpinned by science.

Whatever stage the development programme is in BioVentures Consulting Limited may assess its client’s GMP compliance, QA/QC, safety, production, purification, formulation, characterisation, stability data and documentation. In early-stage development, for example when applying for an IMPD or IND, BioVentures Consulting Limited will assess the methods development. In phase II there will be more focus on methods optimisation and with pre-submission the main focus will be on method validation.

BioVentures Consulting Limited will apply a knowledge-based approach to the development of analytical tests and specifications. This is likely to include a gap analysis of the characterisation tests, QC tests and product quality specification for release testing. Data for release testing can be assessed including stability assays and specifications.

BioVentures Consulting Limited can assess whether all of these tests are validated with appropriate specifications

In conducting a data gaps analysis BioVentures Consulting Limited may conduct data assessment on analytical testing such as raw material testing of drug substance and drug product, in-process testing (including in-process controls), release testing for drug substance and drug product and stability testing. BioVentures Consulting Limited can assess whether all of these tests are validated with appropriate specifications.

Assessment of release specifications may also in itself involve gap analysis of important product characteristics such as the chemical properties, impurities, protein, lipid, carbohydrate, as appropriate) and important product parameters such as purity, safety and quality.

BioVentures Consulting Limited may also conduct a gap analysis of the evolution of stability specifications such as the use of stability indicating tests (which may be different from the release specifications) and ensure the data provide an assurance of product safety, purity and efficacy over the storage period. The gap analysis is also likely to address the issue of impurities, degradation products and storage conditions, including the data available and in-house assessment of stability trend analysis. In addition to the release specification, which may include the appearance, mass, identity or all key components, disintegration time, dissolution and microbial examination; there should also be a gap analysis assessment of the end of shelf-life specification which complies with the release specification.

Analytical validation is an important part of gap analysis. Validation requirements may be defined for each of assay tests, identity tests an impurity tests. Gap analysis should reveal whether analytical procedures such as the accuracy, repeatability, specificity, detection limits, quantitation limits, linearity and range of the analytical validation is available.

Stability tests are a sub-set of the analytical tests, yet they are a very important component of the regulatory submission and hence also of the gap analysis. BioVentures Consulting Limited may assess whether the stability tests are validated and stability indicating. Factors which may be looked at as part of BioVentures Consulting Limited gap analysis exercise may be forced degradation data, accelerated stability studies, degradation pathways and degradation products, container-closure systems for real-time stability testing over the proposed shelf-life under different climate zones and transportation conditions. If gap analysis reveals apparent data gaps the data may be assessed for compliance with appropriate bracketing and matrixing strategies. BioVentures Consulting Limited experience and expertise with gap analysis can provide invaluable feedback on dossier robustness.

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