Analytical Method Development

• Mabion provides a complete analytical method development, optimization, and validation service to support biologics development from early stages through commercialization. Every analytical strategy is tailored to the specific needs of the product and development program.
• The process starts with identifying the Critical Quality Attributes that define product performance expectations. The process includes defining an Analytical Target Profile to ensure every method has a clear purpose and performance requirements.
• For complex molecules, Mabion creates custom assays to reliably assess specific physicochemical and biological parameters.
• Each analytical method is supported by preliminary validation, system suitability testing, and SOPs to ensure robustness, repeatability, and regulatory alignment.

Analytical Method Optimization

We offer a full spectrum of biologics analytical services, including method development, optimization and validation services to guarantee the best performance of your quality control strategies.

Thanks to our systematic but flexible approach, each analytical method is not only tailored to your specific product but also fully aligned with regulatory expectations. Our comprehensive validation process confirms that each method is fit for purpose, ensuring consistent data integrity, reducing variability, and improving batch-to-batch consistency during manufacturing.

Our method optimization process consists of the following steps:

1. Critical Quality Attributes (CQAs) analysis

• Understanding and defining Critical Quality Attributes is the foundation of any robust analytical method. Our team works closely with you to identify and agree on the specific CQAs that must be monitored and controlled to ensure product safety, efficacy, and quality. By pinpointing these critical attributes, we lay the groundwork for selecting, developing and optimizing analytical methods that accurately measure the performance of your biologic throughout its lifecycle. The CQA assessment is meticulously documented with the support of our regulatory team.

2. Method selection and Analytical Target Profile (ATP) development

• Based on the selected CQAs, the development stage and the outcomes of risk analysis, we develop an Analytical Target Profile (ATP) – a detailed roadmap that defines the intended purpose of each method. This ensures that the selected methods are scientifically sound and suitable for your molecule, regardless if they assess potency, purity, or stability.

3. Fit-for-purpose method development

• We focus on developing fit-for-purpose analytical methods that are designed to meet the specific needs of your product at different stages of development. Our methods are efficient and cost-effective while delivering the critical data necessary for decision-making.

4. Custom assay development

• In some cases, standard analytical methods may prove insufficient to provide accurate characterization of a biologic molecule. To address challenges associated with such unique products, we offer custom assay development services. Our expert team can design, optimize and validate a bespoke panel of methods that reliably monitors their specific physicochemical and biologic parameters.

5. Preliminary validation and System Suitability Testing (SST)

• Before formal validation, we conduct a preliminary validation to evaluate key method performance indicators, such as accuracy, precision, specificity, and linearity. The tested parameters are compared against the pre-defined acceptance thresholds. We also implement System Suitability Testing (SST) to ensure that your methods are functioning correctly during routine work. These early-stage assessments help detect and address potential issues, ensuring robustness and reliability of your methods from the beginning.

6. Standard Operating Procedures (SOPs) development

• Clear, precise, and well-documented procedures are essential for repeatability and regulatory compliance. Our team develops detailed SOPs for each analytical method, consistently outlining every step while ensuring traceability. The procedures are fully compliant with Pharmaceutical Quality System requirements, including all necessary capture forms for documentation.

To ensure flawless scale-up, all equipment used in the early development phase at Mabion has its equivalent in the target manufacturing process. Importantly, we arrange continuous process knowledge transfer as your product evolves from lab scale to mass production.

Analytical Method Validation

At Mabion, we offer ICH-compliant method qualification and validation services that set the standard for quality, ensuring the products meet every specification with absolute confidence. Our validation process rigorously tests for accuracy, precision, specificity, range and robustness, guaranteeing that each method is reliable, reproducible, and suitable for its intended purpose. Compliance with the current requirements of ICH, EP, USP and other applicable guidelines is assured by a multidisciplinary Mabion team consisting of process development, QC and regulatory specialists.

Method qualification and validation consists of the following steps:

1. Defining method application based on CQAs and CPPs

• During method qualification and validation, we align each method’s application with both Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs). This alignment ensures that each method is properly suited for its intended use and can effectively monitor the parameters that reflect product quality and process control. By understanding the relationship between CQAs, CPPs, and analytical methods, we ensure comprehensive monitoring and control of your biologic throughout its development and manufacturing.

2. Risk-based approach to qualification and validation

• At Mabion, we take a risk-based approach to method qualification and validation, designing robust and compliant methods that meet global regulatory standards. This strategy ensures that methods are appropriately validated based on the potential risk they pose to patient safety.

3. Compendial methods verification

• We verify compendial methods to ensure full compliance with pharmacopeial standards, including USP and Ph. Eur., providing a clear pathway to market approval. Our thorough verification process customizes these methods to your product, guaranteeing reliable results.

4. Analytical method transfer

• We facilitate the seamless transfer of analytical methods from and to other laboratories, ensuring successful implementation for release and stability testing, while maintaining method integrity and performance. Whether the transfer is internal or external, we guarantee that the methods are executed with the same precision, accuracy, and reliability. Understanding the uniqueness of each method, our transfer strategies are customized to your specific setup, with no one-size-fits-all approach. From transfer protocols to final reports, our documentation provides the transparency and traceability required for internal quality assurance and regulatory submissions.

5. Comprehensive documentation

• Our comprehensive support includes preparing detailed qualification, validation, and transfer protocols, as well as capture forms and reports. We ensure that all prepared documents comply with regulatory and quality requirements.

6. Method lifecycle management

• We manage the entire lifecycle of analytical methods, including continuous improvement, change implementation, and adaptation to evolving regulatory expectations, ensuring ongoing method reliability and compliance. Our lifecycle approach is fully aligned with ICH Q14 and ICH Q2 and other global guidelines, enabling confident navigation in the ever-shifting regulatory landscape.

By integrating these advanced methodologies, Mabion ensures that every step of biologics analytical services adheres to the highest standards of quality, safety, and compliance.