Drug Characterization & Release Testing

Molecule CQA Determination and Analytical Method Development

In order to ensure full regulatory compliance, characterization of the molecule must be started at the earliest stages of development.
Mabion’s specialist team can help your company achieve this goal through the following set of services:

• Reviewing or determining Critical Quality Attributes (CQAs) of the developed molecule
• Selection of adequate methods based on CQAs, stage of development and purpose (Analytical Target Profile) using risk-based approach
• Fit-for-purpose method development for your molecule (including DoE approach), or adjusting the platform methods available at Mabion
• Developing customized, product specific assays including identity confirmation by mass spectrometry or process-specific host cell protein assays
• Writing standard operating procedures for analytical methods in accordance with GMP or Pharmaceutical Quality System requirements, including capture forms

ANALYTICAL METHOD DEVELOPMENT

Method Qualification/GMP Validation/Transfer

Design, validation and transfer of analytical methods are crucial steps in biologic drug development. At Mabion we work in efficient and flexible manner, using state-of-the-art techniques, in order to meet our Clients’ demands. We can offer methods based on available platforms, develop method from scratch or accommodate/transfer available Client’s methods. Full-GMP ICH compliant method validation or transfer procedures are available for use.
Every biologic molecule is unique and inherently complex. Recognizing these basic facts, Mabion’s team adopts tailored and flexible approach to the development and qualification of analytical methods, combining previous knowledge with openness to new solutions.
Our expert team is ready to help you with adjusting validation or transfer testing to the current requirements of ICH, Ph. Eur., USP and other applicable guidelines. Offered services include:

• Design of the methods to be used for drug characterization, analytical comparability studies to support process changes as well as QTPP / similarity / comparative analytical assessment for biologic products
• Comprehensive analysis of biologic molecules by the developed and qualified methods
• Designing the GMP validation or transfer activities with use of risk-based approach
• Transferring the analytical methods from other laboratories for release/stability testing
• Writing the supporting documentation: qualification/validation/transfer protocols, capture forms and reports
• Supporting the method lifecycle including method improvements and change implementation

ANALYTICAL METHOD QUALIFICATION / VALIDATION / TRANSFER

Comprehensive Drug Characterization

Mabion offers multilevel support in analytical testing of biologics/biosimilars and vaccines across all development phases. Our expertise includes various structural, physicochemical and biological analyses.

Our dedicated team of experts would be happy to support you in the following activities:

• Characterization studies with use of selected methods or full method panel for a given product, including mass spectrometry and bioassays
• Comparability studies supporting manufacturing process changes
• QTPP studies, including experience in reference product sourcing
• Similarity/comparative analytical assessment studies for candidate biosimilars products
• Generation, characterization and bridging of reference standards
• Stress/forced degradation testing in support of comparability/similarity studies
• Freezing stability studies

Mabion has capabilities to test the drug substance, drug product and in process samples or intermediates for: protein content, physicochemical properties, product-related impurities/variants/aggregation, primary structure and identity, biologic potency, glycosylation, purity, sterility/bioburden as well as particles, extractable volume and dosage uniformity. Based on acquired data, we can support specification development and shelf-life determination. Statistical services are also available for our Clients as is the preparation of all documents required for subsequent application filing.

GMP Release and Stability Testing

Our GMP testing services span multiple assays to determine content, impurities, identity, purity, potency and excipients, including compendial assays. We offer custom-design studies compliant with ICH standards.
Specific services included in our portfolio are:

• Release testing of drug substance and drug product
• Testing of intermediate products/in-process pools as part of the control strategy
• Raw materials release testing
• QP release of Drug Product
• Stability testing (in-process samples, intermediates, drug substance and drug product)
• Biosafety testing (Sterility/Bioburden, Mycoplasma and Endotoxin testing)

Stability testing includes long-term, accelerated stress stability studies (forced degradation) and others (freeze/thaw and in-use stability), including comparative studies for comparability/similarity assessment. Stability studies can be conducted in various temperature conditions from -80°C to 70°C.