Ensuring the quality and stability of drug products requires rigorous analytical testing throughout the development life cycle. By leveraging Good Manufacturing Practice (GMP)-compliant analytical methods — both standardized and customized — biopharma companies can mitigate risks, maintain regulatory compliance, and accelerate development timelines. As drug modalities become increasingly complex, specialized analytical capabilities are essential for ensuring consistency and accuracy of data, as well as long-term product integrity.
Assuring Quality and Safety across the Product Life Cycle
Release and stability testing are fundamental to maintaining the quality and safety of drug products. To ensure that these standards are met, analytical methods must be carefully developed, validated, and conducted in accordance with Good Manufacturing Practice (GMP) requirements. These methods provide the necessary assurance that drug products remain safe, effective, and compliant throughout their entire life cycle.
Release testing confirms that drug substances and drug products meet defined specifications immediately following manufacturing. Stability studies, on the other hand, assess whether product quality is maintained over time, ensuring consistent efficacy and safety during product shelf-life. When conducted in a GMP environment, these tests rely on validated methods, qualified equipment, and trained personnel, guaranteeing the reliability of analytical results.
The complexity of maintaining quality across a drug’s life cycle is underscored by the need for analytical life cycle management. A drug product may remain on the market for 15 years or longer, requiring the analytical methods to deliver accurate, robust, and consistent results over time. This challenge is further compounded by inevitable changes — whether in manufacturing processes, regulatory requirements, or analytical technologies. Analytical service providers must be flexible and able to allow seamless adaptation of GMP methods to evolving requirements while maintaining data integrity and comparability.
A critical aspect of GMP analytics is its role in detecting trends in product quality that may emerge across multiple production batches. Small, incremental variations may not be immediately relevant for product quality or safety but can become significant when assessed across multiple production cycles, as they indicate drifts in the manufacturing processes. A well-characterized product and reference standard are of crucial importance for evaluation of such changes. By implementing finely tuned and robust analytical controls, companies can identify trends early and proactively address potential risks.
At Coriolis Pharma, we prioritize the integration of appropriate methods early in the development process, aligning them with formulation efforts to ensure a seamless transition from preclinical studies through commercialization. We aim to start with working on “qualified equipment” and to develop robust analytical methods that can further on be GMP-controlled and validated to support drug development from first-in-human trials through late-stage clinical phases, process performance qualification (PPQ), and commercial supply. By establishing high-quality, GMP-compliant methods early, we help ensure data continuity, regulatory compliance, and long-term product stability.
Integrating Analytics, Formulation, and Manufacturing for Stability
The interdependence of analytical methods, formulation development, and manufacturing processes is critical to ensuring drug product quality and stability. This relationship becomes even more pronounced with complex and sensitive modalities that present unique stability challenges, such as biologics, cell and gene therapies, and other advanced therapeutic platforms.
For these challenging molecules, stability considerations must be embedded into formulation and manufacturing strategies from the outset. Formulation expertise — developed through extensive hands-on experience across various modalities and dosage forms — enables the creation of robust formulations that minimize the risk of degradation. Similarly, a deep understanding of how processing conditions impact sensitive molecules allows for the implementation of appropriate process controls and helps to shape optimal manufacturing processes that together enhance long-term product stability.
High-performing analytical techniques must be capable of detecting even subtle stability-related changes while ensuring that test conditions do not introduce artifacts or distort results. By integrating rigorous analytical controls early in development, companies can confirm product stability with confidence and proactively address potential risks before they impact drug performance.
Developing Appropriate Methods for Each Phase of Drug Development
Coriolis offers different level of methods, each appropriate for the specific study and phase of clinical development. Method can be established or developed under R&D conditions, performed on GMP-qualified equipment, or partially/fully validated, including Coriolis QA approval. Platform methods can be quickly used for example in early-phase developability studies or established in GMP-qualified equipment, whereas product-specific methods can be tailored to the clients´ and products´ needs.
Analytical methods must evolve alongside drug development, with different levels of complexity and regulatory rigor applied at each stage. At Coriolis Pharma, this phased approach ensures that testing remains fit-for-purpose while enabling a seamless transition from early-stage research to commercial production.
Coriolis offers four tiers of analytical methods, each designed to match specific project needs:
Platform-based R&D methods: Non-GMP, standardized techniques used during early-phase developability assessments.
Product-specific R&D methods: Non-GMP methods adapted to individual drug products to refine analytical strategies.
GMP gradient methods: Analytical methods developed, established, and performed on GMP-qualified equipment and following GMP-like standards but not yet validated.
GMP methods: Methods developed, established, validated, and performed under GMP regulations, ensuring compliance for in-human use and commercial production.
Selecting the appropriate method quality level depends on the project stage and the client’s goals. Using GMP gradient methods early in development can provide significant advantages, as data collected under GMP-compliant conditions is more comparable to data of later GMP materials. This consistency allows for better data trending and smoother regulatory submissions. Moreover, regulatory agencies are increasingly requiring that even early-stage clinical materials be tested in GMP-compliant environments, reinforcing the importance of integrating these methods as early as possible.
A quality-by-design (QbD) approach further enhances method development by defining a robust analytical design space. This strategy ensures that methods are not only optimized for performance but also adaptable to future process or regulatory changes. Failing to anticipate these requirements can result in costly setbacks, including analytical methods that fail validation under GMP conditions or produce out-of-specification results. By integrating QbD principles from the outset, Coriolis helps clients avoid these pitfalls, ensuring long-term method sustainability and regulatory compliance.
Advancing Analytical Capabilities for Emerging Modalities
As the pharmaceutical industry continues to evolve, service providers must expand their analytical capabilities to accommodate an increasingly diverse range of drug modalities. Beyond knowing when to implement GMP methods and offering both platform-based and customized solutions, analytical labs must develop specialized expertise to support the latest advancements in biopharmaceuticals.
Coriolis Pharma has built an extensive portfolio of qualified and validated GMP assays for purity, identity, potency, and other critical quality attributes, extending well beyond standard compendial methods. For widely established modalities, we employ industry best-practice analytical techniques that are ready to deploy. However, for novel and highly specialized drug products, additional method development and optimization are required to ensure suitability for each specific application. When necessary, entirely new methods are qualified and validated under GMP standards, provided GMP-compliant equipment is available.
Our expertise enables us to pioneer advanced analytical techniques that address some of the industry’s most complex challenges. For example, we offer GMP-compliant analytical ultracentrifugation (AUC) for viral vectors, a highly specialized method that currently lacks an established regulatory monograph.
In general, novel methods or techniques are introduced into pharmaceutical development with the aim to improve efficiency and precision, reducing analytical turnaround time and enhancing data accuracy. In other instances, innovative techniques allow driving deeper insights into product quality and stability, which was previously not required. Driving the analytical frontier forward during formulation development studies, Coriolis is offering the best possible solutions for its clients, including polysorbate characterization and quantification, as well as liquid chromatography–mass spectrometry (LC-MS) methods under GMP conditions, addressing an emerging regulatory focus area that has become increasingly important for clients in recent years.
By continually investing in the development of cutting-edge analytical methods, Coriolis not only provides invaluable support to its clients but also contributes to the broader advancement of pharmaceutical science — helping to accelerate the development and commercialization of next-generation therapies.
Seamless Stability and Release Testing from R&D to Commercialization
Robust analytical methods are essential at every stage of drug development, from preclinical studies to commercial manufacturing. Consistency in analytical testing is particularly valuable when multiple suppliers are involved — for example, when one contract development and manufacturing organization (CDMO) produces the drug substance and another handles fill/finish operations, or multiple suppliers are providing commercial-scale manufacturing. Regardless of these transitions, release and stability testing must remain consistent to ensure product quality, safety, and regulatory compliance.
As new suppliers are introduced, comparability studies become necessary to demonstrate consistency across different manufacturing sites. This process requires analytical methods that are both highly reproducible, accurate, and validated, ensuring that product quality is maintained regardless of production scale or location.
Coriolis Pharma is uniquely positioned to support biosimilarity, comparability, release, and stability testing across the entire value chain. Our GMP methods are developed alongside formulation efforts, providing early analytical robustness that helps derisk projects from the outset. When a formulated product is transferred to a fill-finish CDMO, we deliver a comprehensive analytical package that seamlessly integrates into manufacturing processes.
In addition to GMP analytical testing, we offer standalone analytical services, including non-GMP and GMP gradient orthogonal methods to validate and reinforce initial GMP results. This flexibility is particularly valuable when validated GMP methods encounter unexpected challenges, requiring rapid troubleshooting and alternative analytical strategies. With our extensive laboratory capabilities and agile operational setup, we can swiftly deploy both non-GMP and GMP analytical testing and stability testing solutions — helping our clients maintain uninterrupted project timelines and regulatory compliance.