Analytical development
An efficient Analytical Development strategy is critical to any pharmaceutical drug development program. Reliable and reproducible analytical methods are essential for both the pharmaceutical development process and drug product evaluation to meet standards of potency, purity, and stability. Method development is a continuous process that runs parallel to drug development.
The market demands innovative analytical techniques that are effective and efficient. Time and cost reduction are crucial for every organization. Therefore, advanced analytical methods are developed and validated for various pharmaceuticals, including raw materials, active pharmaceutical ingredients (API) and excipients.
Regulatory Focus on Analytical Development
In addition, regulatory authorities are more focused on analytical development and the performance of analytical methods in production performed by Quality Control laboratories. They will assess whether scientific and risk-based approaches are used to develop and maintain analytical procedures appropriate for the assessment of drug product quality. Examples of minimum requirements include the identification of the drug product properties to be tested and a suitable control strategy for the analytical procedure, as defined by the European Medicines Agency (EMA): ICH Q14 Guideline on analytical procedure development_Step 5 (europa.eu).
Progress experts understand the complexity when it comes to analytical development. They can support you in a thorough evaluation of existing instruments and methods that may be needed for the introduction of new medicines and reporting of new toxicities. Methods may need to be modified to meet the criteria. This means that other instruments may need to be purchased to improve or validate current sample testing methods, for which we can help you make the right decision. We also provide Quality Control experts.
The purpose of the method should reflect the stage of drug development. During early drug development, methods must be appropriate to support preclinical safety assessments, preformulation studies, and product stability studies. Up to and including Clinical Trial Phase 1, analytical methods only need to be qualified and not validated. Linearity, precision, accuracy, and specificity are sufficient at this stage. As drug development progresses, analytical methods are refined and expanded based on increased drug product knowledge. Method validation must be completed as the drug progresses through Phase 2 and Phase 3 clinical trials and commercialization.
Accurate instruments are essential components of analytical development
Bioanalysis
Regulated bioanalysis is an important part of pharmaceutical programs at all stages, from preclinical to late phase development. Drugs, metabolites, and biomarkers are selectively quantified by analyzing samples derived from blood draws (plasma/serum), urine or tissue collection. The resulting concentration data are input for the important PK/PD and safety determinations. (Bio)analytical methods to be used for these analyzes must be developed, transferred, qualified and/or validated according to strict global guidelines issued by, amongst others, US FDA (Food and Drug Administration) and EMA (European Medical Agency). Part of pre-clinical development should be performed as GLP (Good Laboratory Practice)-regulated studies and the principles of this regulation will be followed in the clinical stages where GCP (Good Clinical Practice) is also important. How can we help you with bioanalysis? If you have no bioanalytical capacity and/or expertise in-house, Progress can support your bioanalytical needs with.
- Finding the right partner for your bioanalytical projects by selecting, auditing, and contracting a CRO (clinical research organization).
- Project management services for outsourcing your study and subsequent tasks such as coordination with the clinics, data management and logistics providers.
- Fulfilling interim positions such as GLP Study Director or Principal Investigator.
- Prepare and review documentation, including study plans and reports, method validation reports and work instructions, data transfer and logistical agreements, clinical protocols etc.
For existing bioanalytical packages, we can perform a gap analysis before submitting your file to regulatory agencies. If you are facing an audit or inspection by a regulatory body, we can help you prepare for this by performing an audit readiness check and/or a mock audit. Moreover, we can support you in responding to information requests or audit findings.
Progress specialists can also offer support for your own bioanalytical laboratory or experts in house. If you want to design and build your own bioanalytical lab, set-up or update your QMS for bioanalysis or prepare for GLP certification, we are here to help you with our Quality expertise.