Analytics 

• At Mabion, we offer a comprehensive panel of analytical services that are crucial to the successful development, manufacturing, and commercialization of biologics. As the complexity of biologic drugs requires precise and sophisticated testing, our state-of-the-art laboratories and highly experienced team are equipped to support your product from early development through commercial launch. Our analytical services encompass every stage of the product lifecycle, ensuring the highest standards of quality, safety, and regulatory compliance at each step.
• From method optimization and validation to advanced drug characterization and bioanalytics, we tailor our analytical solutions to meet the unique needs of your biologic. Our services ensure the precise monitoring and control of critical quality attributes (CQAs) and critical process parameters (CPPs) throughout the process development, while our rigorous cGMP release testing guarantees that your product consistently meets regulatory requirements for clinical or market release. Additionally, our extensive stability studies secure the long-term performance of your product by measuring its shelf life and optimal storage conditions.
• Mabion offers a broad panel of analytical methods, including potency, purity, and sterility assessment to guarantee consistent quality throughout the entire process of biologic drug development and manufacturing. Our analytical team performs rigorous testing, including cGMP-compliant release testing and stability assessments, ensuring the delivery of safe and potent drug product.
• Unlike some other CDMOs, Mabion also offers a wide range of bioanalytical services to support in vitro biologic activity studies as well as pharmacokinetic, pharmacodynamic and immunogenicity assessments in early phase studies. Our rich experience includes analysis of thousands of PK and immunogenicity samples from Phase III biosimilar trials using validated, EMA-compliant in-house methods.
• All analytical services are performed in strict compliance with International Council for Harmonization (ICH) guidelines as well as European and United States Pharmacopeia (EP and USP) standards, with a strong focus on the Quality by Design (QbD) approach. This methodology ensures that our analytical methods are optimized, robust, and consistently deliver reliable results across all stages of drug development.

Since the founding of Mabion in 2007, we have established over 30 analytical techniques, which cover the core structural, physicochemical and biological methods used in the biopharmaceutical industry for process and product characterization as well as product release and stability testing.

A detailed list of analytical methods performed in-house at Mabion is presented below:

Methods development, optimization and validation

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.

Method development and optimization

Our method optimization process consists of the following steps:

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.

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.

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.

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.

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.

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.

Methods 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:

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.

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.

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.

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.

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.

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.

Drug Characterization

Mabion offers comprehensive drug characterization services, designed to provide an in-depth knowledge of your product’s molecular structure, functional properties, and quality attributes. These services include but are not limited to biosimilars comparability and similarity studies, reference standard characterization and impurities profiling,

Whether developing a novel biologic or a biosimilar, we offer customized solutions to meet the specific needs of your product, helping to streamline the development process and ensure long-term success. By leveraging advanced techniques and state-of-the-art technology, we deliver accurate and detailed insights into your drug substance, allowing for informed decision-making at every stage of development and production.

Mabion’s expert analytical team will ensure that your biologic meets the highest standards of purity, efficacy, and regulatory compliance. Our drug characterization portfolio includes:

Drug Substance characterization

• Mabion offers comprehensive drug substance characterization services to ensure a thorough understanding of your biologic’s critical quality attributes. Using advanced analytical techniques, we provide detailed insights into the molecular structure, purity, and functional properties, supporting regulatory compliance and consistent product performance. An example of the high quality of our biologics analytical services is the rituximab case study, which examined the glycosylation profile, a critical parameter in the development of biosimilar drugs.

Biosimilars comparability and stability studies

• A key aspect of biosimilar development is demonstrating that the proposed biosimilar is highly similar to its reference biologic in terms of quality, safety, and efficacy. Our biosimilars comparability and similarity studies are designed to assess the molecular and functional similarities between the biosimilar candidate and the reference product. We employ a range of sophisticated analytical methods, including physicochemical characterization, structural analysis, and biological activity assays, to compare critical quality attributes (CQAs) such as protein structure, post-translational modifications, and functional activity. Our comprehensive comparability studies support regulatory submissions by ensuring that any observed differences do not impact clinical performance, thereby accelerating the approval process for biosimilars.

QTPP studies

• Our specialists will prepare a Quality Target Product Profile (QTPP) for your biologic, defining the key quality attributes, guiding product development and ensuring alignment with regulatory expectations.

Forced degradation testing

• Mabion provides Forced Degradation Testing to assess the stability and degradation pathways of your biologic under various stress conditions. This testing helps identify potential weaknesses in your product’s stability profile, informing formulation development and stability strategies.

Stability studies

• Stability studies are designed to ensure that biological products maintain their safety, quality and efficacy throughout their shelf life. These tests evaluate the effects of various environmental factors, such as temperature, humidity and light, on product characteristics. The ICH guideline specifically address the unique structural complexity and sensitivity of biological products, emphasizing the need to assess critical quality attributes, including potency, purity and biological activity. Stability studies support the determination of appropriate storage conditions, shelf life and useful life. Our biologics analytical services range includes performing real-time, accelerated and stress testing to ensure product stability during development, production and commercialization. For more information please refer to chapter on cGMP stability studies.

Reference standard characterization

• Reference standards are a cornerstone of analytical method development, validation, and routine quality control in the development and manufacturing of biological drugs. These standards provide a benchmark for ensuring the consistency, accuracy, and reliability of analytical testing throughout the product lifecycle. Our Reference Standard Establishment and Characterization service offers an expert guidance and technical support throughout the entire process, including:
  • Initial standard selection
  • Characterization of identity, purity and potency
  • Stability testing
  • Calibration and traceability
  • Standards’ bridging

Impurities profiling

• Impurity profiling is essential for ensuring the safety and efficacy of biologic products by identifying and quantifying process – and product-related impurities. Our impurity profiling services include:
  • Process-related impurities: Identification and quantification of impurities such as host cell proteins, residual DNA, and endotoxins.
  • Product-related impurities: Analysis of product-related impurities, including aggregates, degradation products, and different variants resulting from differences in post-translational modifications.

Routine and in-process testing

Routine and in-process quality testing are essential for ensuring that your biologic products are consistently manufactured and meet predefined quality specifications. Our in house state-of-the-art laboratories, equipped with advanced analytical technologies, are staffed by an experienced team of scientists dedicated to delivering high-quality, reliable testing data.

Our services include:

In-process testing

• We continuously monitor critical process parameters (CPPs) to maintain tight control over each stage of the process, preventing deviations and ensuring consistent product quality. We implement real-time monitoring and testing during key stages of production to evaluate critical quality attributes (CQAs) such as purity, potency, and concentration. By closely tracking these parameters, we identify and address potential issues early, minimizing risks and ensuring that the manufacturing process remains consistent, efficient, and fully compliant with regulatory requirements. This testing also allows for continuous process optimization, helping to enhance product yield, stability, and overall performance.

Routine quality control

• Our comprehensive QC testing includes assessments of identity, potency, purity, and sterility, ensuring that each batch of your drug substance or drug product adheres to the required quality standards prior to the release. Utilizing a wide array of analytical techniques, such as HPLC, mass spectrometry, ELISA, and cell-based assays, we test both intermediates and finished products, providing reliable and accurate data for release testing. Our routine QC services are designed to support both clinical and commercial production, ensuring that your biologic product remains safe, effective, and consistent throughout its lifecycle.

Method transfer and adaptation

• Ensuring smooth and accurate method transfer and adaptation is essential for the successful progression of biologic products from development through to commercial manufacturing. At Mabion, we offer seamless method transfer services, ensuring that analytical methods developed during early phases of product development are successfully transferred and adapted for use in our cGMP-compliant laboratories. Our team works closely with you to understand the intricacies of your product’s analytical methods, ensuring their precise replication and optimization during the transfer process. We also perform gap analysis and validation to adapt methods as needed, ensuring they are fit for purpose and meet the specific requirements of the production environment. This process guarantees that critical quality attributes are accurately measured, and the integrity of the product is maintained during scale-up and commercialization.

cGMP release testing

We offer a broad range of release testing services covering active pharmaceutical ingredients (APIs), investigational medicinal products (IMPs) and finished commercial products, as well as biosafety and stability testing. With a strong commitment to quality, regulatory compliance, and reliable data, Mabion’s release testing services help ensure that your biologic product is fit for clinical trials or for commercial distribution.

Our QC team employs a wide array of analytical technologies to verify that products comply with established criteria. Our experience and know-how in batch release testing includes chemical, physical and biological tests (including compendial assays) as well as microbiology methods. We also offer the execution of custom-design studies, in full compliance with ICH guidelines.

All microbiological tests are performed in our laboratory within a cleanroom environment. Sterility and bioburden tests are carried out in dedicated grade B-A cleanrooms, specifically built for these purposes.

Along with comprehensive cGMP testing, our services include batch release by a Qualified Person (QP) (for EU market) or Quality Control (QC) unit (for US market), in accordance with the applicable directives.

Specific services included in our offer are:

Release testing of Drug Substances and Drug Products

• Mabion’s release testing for drug substances and drug products ensures that every batch meets predefined quality standards and regulatory requirements before it can be released for clinical or commercial use. We perform a range of critical tests to assess purity, potency, identity, and sterility, using sophisticated analytical methods like HPLC, mass spectrometry, and ELISA. By providing thorough testing of both the active drug substance and the final drug product, Mabion helps you maintain high-quality standards, ensuring patient safety and product efficacy across all batches.

Testing of intermediate products / in-process pools

• As part of our comprehensive quality control strategy, Mabion offers in-depth testing of intermediate products and in-process pools during the production process. This in-process testing ensures that each critical stage of the manufacturing process is properly monitored, helping to detect potential issues early and avoid deviations from quality standards. By testing intermediate pools, such as bulk drug substances or purification intermediates, we provide insights into process consistency, yield optimization, and product stability. This proactive approach helps reduce risks, ensuring the final product meets the desired quality attributes before progressing to the next production phase.

Raw materials release testing

• Ensuring the quality of the raw materials used in biologic production is crucial for the overall integrity of the final product. Mabion offers raw materials release testing to verify that all materials entering the manufacturing process meet strict specifications for purity, identity, and quality. This testing helps to minimize risks associated with contamination, variability, or impurities that could compromise product quality.

QP release of Drug Products

• Mabion provides Qualified Person (QP) release services, ensuring that drug products meet all regulatory requirements and quality specifications before they are released to the market. Our QP services include a thorough review of all relevant manufacturing, quality control, and stability data, ensuring that each batch complies with cGMP and other regulatory standards. The QP certification process guarantees that the product has been manufactured and tested according to the approved specifications and is safe for clinical trials or commercial use. This final verification step ensures full compliance with European regulatory requirements and boosts confidence in the product’s quality.

Stability testing (in-process samples, intermediates, DS and DP)

Please refer to chapter on cGMP stability testing.

Biosafety testing (sterility/bioburden, Mycoplasma and endotoxins)

• Ensuring the biosafety of biologic products is paramount, and Mabion provides extensive biosafety testing services, including sterility/bioburden testing, Mycoplasma detection, and endotoxin testing. These tests ensure that your biologic product is free from contamination by harmful microorganisms or toxins, which is critical for both patient safety and regulatory approval. Mycoplasma detection is performed with the use of highly sensitive, validated qPCR assay, with much shorter turnaround time than traditional culture-based methods (see our article on Mycoplasma testing).
• Endotoxin testing is conducted to detect and quantify endotoxins, which can pose serious safety risks if present in biologic products. Our biosafety testing services provide confidence that your product meets the highest standards of purity and safety.

cGMP stability studies

Our cGMP stability testing services allow for extensive characterization of a drug product’s shelf life under various environmental conditions. We offer stability studies across the entire drug lifecycle, including pre-clinical, clinical, registration and commercial phase.

Our advanced stability testing services adhere to stringent cGMP guidelines, offering a robust framework to support regulatory submissions and product lifecycle management. With state-of-the-art facilities, including qualified stability chambers and continuous temperature monitoring systems, we ensure that your biologic product maintains its critical quality attributes under a variety of storage conditions.

Mabion’s stability studies encompass a wide range of storage conditions to simulate real-world environmental exposures and stress factors that biologics may encounter during manufacturing, storage, distribution, and use. Our qualified stability chambers are calibrated to maintain precise conditions across multiple temperature and humidity settings, including:

Additional conditions can be tested to meet the specific product requirements.

Our stability chambers are fully qualified and regularly mapped for long-term and accelerated testing, providing consistent, controlled environments, essential for generating reliable stability data.

We maintain continuous temperature monitoring systems and backup power solutions to ensure uninterrupted testing, even during power outages. Any deviations in temperature or humidity are immediately detected and addressed, ensuring that your stability data remains accurate and valid. These monitoring systems provide detailed logs, which are available for review during regulatory inspections and ensure compliance with global regulatory standards. Our laboratory uses validated analytical methods that provide accurate assessment of drug’s stability profile.

Clinical and pre-clinical analytics

Pharmacokinetics, pharmacodynamics and immunogenicity assessments are integral parts of preclinical and clinical development of biologic drugs. Unlike many other CDMOs on the market, Mabion aims to be a true end-to-end partner, offering not only broad manufacturing and quality control services, but also supporting companies in developing and running bioanalytical assays.

By partnering with Mabion you gain access to comprehensive bioanalytical services for assessing the PK, PD and immunogenicity profiles of therapeutic proteins including comparative assessment of innovative and biosimilar antibodies. Our well-qualified bioanalytical team will make sure that all developed methods are perfectly adapted to your products, delivering efficient and high-quality analyses.

In our dedicated bioanalytics laboratories we develop high throughput bioanalytical methods customized to the pharmacologic properties of a given molecule and its biological targets. Using cutting-edge equipment, such as Gyrolab xPlore^TM, we set up specific and sensitive assays for assessing immunogenicity of innovative drugs, biosimilars and vaccines.

All analyses are meticulously documented and summarized in an appropriately formatted report.

Whether you’re working on preclinical or clinical development, Mabion offers a full range of bioanalytical solutions to support PK, PD, and immunogenicity assessments. Our bioanalytical services include the assessment of:

Pharmacokinetics

• Evaluation of pharmacokinetics of monoclonal antibodies and other biologics within pre-clinical and Phase I-III clinical studies. Analysis is performed with the use of high-throughput Gyrolab xPlore^TM or ELISA platform. The use of this fully-automated platform significantly increases the quality of the obtained data while reducing the analysis time compared to the classical assays.

Pharmacodynamics

• Assessment of pharmacodynamics is performed with the use of flow cytometry (BD FACSLyric^TM) and immunoassay platform (Gyrolab xPlore^TM). The methods developed at Mabion are appropriate for any drug (biologic or not) that works by lowering the concentration of specific cell types and proteins circulating in the blood. They can also be extended to measure the quantity of specific proteins in various body tissues and fluids. The use of automated and standardized flow cytometry and immunoassay platforms allows us to achieve higher speed, better control and increased reproducibility of the performed tests.

Immunogenicity

• End-to-end immunogenicity assessments performed at Mabion include anti-drug antibodies (ADAs) testing with screening, confirmatory and titer assays, followed by neutralizing antibodies testing with use of competitive ligand-binding assay and bioassay formats, including ADCC cell-based assays. Our assays are recognized for high speed, reproducibility and sensitivity of testing at a level consistent with the expectations of EU and US regulatory authorities.