Ramesh Jagadeesan, vice president, head of analytical services at Recipharm shares his insights on the role of analytical services in drug development.
Drozd Irina Shutterstock
1. What are analytical services?
Analytical services play a crucial role in the pharmaceutical industry by ensuring the quality, safety, and efficacy of drug products through rigorous scientific testing. These services encompass method development and validation, stability studies, impurity profiling, elemental analysis, and advanced characterisation techniques like Nuclear Magnetic Resonance (NMR), X-ray Diffraction (XRD), and various spectroscopic methods.
A systematic approach, such as Quality by Design (QbD) and risk-based methodologies, ensures that analytical procedures are robust and reliable. Additionally, method validation activities focus on accuracy, precision, specificity, and robustness, ensuring compliance with global regulatory standards, including those set by ICH, FDA, and EMA.
Beyond traditional testing, specialised analytical services such as in vitro release/permeation testing (IVRT/IVPT) help evaluate drug delivery performance, while sterility and endotoxin testing ensure microbiological safety for injectable products.
Reverse engineering is another key aspect, particularly for generic drug development, where qualitative (Q1), quantitative (Q2), and physicochemical (Q3) assessments help optimise formulations while maintaining therapeutic efficacy. Extractables & leachables studies, nitrosamine detection, and unknown impurity identification further enhance product safety and regulatory compliance. With instrumentation and scientific expertise, analytical services provide pharmaceutical companies with the essential tools to optimise formulations, meet regulatory requirements, and maintain high-quality standards throughout a product’s lifecycle
2. What are the different development methods for each stage of the process - early development, late-stage, commercial manufacturing?
Analytical method development and validation play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products. The complexity of these methods evolves alongside the clinical trial phases as our understanding of the drug product improves.
In Discovery and Phase I, analytical procedures are relatively simple due to limited knowledge about the manufacturing process and impurity profile. At this stage, basic chemical purity tests are typically sufficient since characterised reference materials are not yet available. The focus is on generating preliminary data to support early development.
By Phase II, as more information about the drug’s impurity profile and stability emerges, analytical methods become more refined. Adjustments, such as optimising column selection and gradient conditions, improve peak resolution and impurity detection. Characterised reference materials for both the drug and known impurities become available, enabling more accurate quantification. The method transitions from a basic assessment tool to a more robust and specific analytical approach.
In Phase III, with the goal of commercial readiness, analytical methods undergo further optimisation to enhance sensitivity, reproducibility, and regulatory compliance. This may include refining sample concentrations to improve detection and quantitation limits. By this stage, reference standards for both the drug and impurities are well-established, ensuring high precision in quantification. The method is now validated to support process validation and long-term stability studies, forming the foundation for regulatory submission.
Throughout these phases, compliance with international regulatory standards such as ICH, FDA, and EMA guidelines is essential. A well-developed analytical strategy not only ensures data integrity but also facilitates a smoother approval process, ultimately supporting successful drug development and commercialisation.
3. What advice would you give to customers looking for support with analytical services?
When outsourcing analytical services, selecting the right partner is critical for ensuring quality, reliability, and compliance. Start by evaluating the provider’s experience—a well-established company with a strong track record in your industry is more likely to deliver accurate and regulatory-compliant results. Client testimonials and reviews can provide valuable insights into the provider’s expertise, customer service, and reliability. Positive feedback from companies in similar fields is a strong indicator of a trusted partner.
Timeliness and integrity are also key factors. Analytical services often involve sensitive data, and delays or inaccuracies can impact development timelines. Choosing a provider known for professionalism, transparency, and responsiveness ensures a smooth collaboration. Beyond expertise, conducting an on-site audit of the laboratory helps verify their method transfer capabilities, equipment maintenance, and regulatory adherence.
Ultimately, finding a partner with the right mix of technical expertise, industry experience, and a strong reputation will help you achieve high-quality analytical results while maintaining regulatory compliance.