Analytical and Quality Characterization Services
Analytical Solutions to Guide the Clinical Lifecycle and Commercial Manufacturing
Analytical methods are the key to understanding your biopharmaceutical product from preclinical through commercialization. As your CDMO partner, we support your path to success with access to innovative and leading-edge technologies for testing and characterization as a single comprehensive provider.
Our analytical services extend throughout the product lifecycle from process development to clinical and commercial cGMP release testing. We provide broad solutions to support all aspects of testing and characterization for IND/IMPD or BLA/MAA applications. We will navigate you through the new era of regulations for biologics and advanced therapies such as Q2 (R2), Q5A (R2) and Q14, and guide you through current regulatory requirements for GMP testing and CMC characterization.
As such, we are continuously investing in leading-edge technologies, and recently expanded in-house resources for raw-material, bulk harvest biosafety and process residual testing to allow us to meet changing regulatory and customer needs.
Each of our sites has analytical testing and quality control capabilities. At every stage of clinical development and commercial-scale manufacturing, our experienced people support your analytical needs with quality CMC focused services.
Expert Analytical Capabilities for Your Biopharmaceutical Product
Guiding a biopharmaceutical product through the clinical to commercial journey and ensuring it is safe, effective and commercially viable starts with – and relies upon – understanding its complex nature.
This knowledge drives its quality and manufacturability. Our analytical development and quality control teams specialize in the development, transfer and phase-appropriate validation of methods to meet CMC requirements to assess the physiochemical and biochemical characteristics of each product, and to ensure their quality and consistency during manufacturing.
We collaborate closely with partners to ensure that the developed methods align with their specific needs. When you partner with us for analytical development, product characterization and quality control testing, we ensure success by:
- Exploring the structure and behaviour of your molecule in the early stages of development
- Understanding the product’s quality attributes under a variety of solution and stress conditions to drive process development
- Designing methods that have a line of sight from early process development through all stages of clinical and commercial cGMP manufacture
- Building quality into the product, maximizing the design space and minimizing risk in method performance
- Having access to leading-edge analytical capabilities to define the structural characteristics required for regulatory filings
- Having access to a global network that provides seamless support for raw materials, biosafety, virology and process residual testing required for a biopharmaceutical manufacturing process
Learn more about our analytical capabilities for:
Analytical Testing and Characterization Services for Protein Biopharmaceuticals
Developing analytical methods and testing complex proteins requires expertise and leading-edge instrumentation. Benefit from capabilities that are comprehensively tailored to your requirements and timelines, including:
- Method transfer
- Establishment of platform methods for mAb processes
- Development of customized methods including bioassays
- Biological, physiochemical and biophysical characterization
- Phase-appropriate validation
- Stability indicating properties/forced degradation
- In-process and release testing
- Release drug substance, drug product, and assembled device testing
- cGMP stability studies
- Clinical in-use studies
- Reference materials
- Comparability testing
- Characterization capabilities for IND/IMPD or BLA/MAA filings
Throughout the lifecycle of your program, we work with you to provide appropriate methodologies. Our capabilities and instrumentation cover the requirements for comprehensive cGMP Quality Control testing of a biopharmaceutical product which includes:
- Cell banking
- Raw materials
- Safety
- Mycoplasma
- Adventitious Virus
- Quality
- Bioassay and potency testing
- Stability
- Identity
- Purity
- Process impurities and residuals
- Container and package testing
- Cleaning
- Environmental monitoring
- Organism identification
We can provide comprehensive analytical characterization capabilities to support all 3.2.S.3 characterization filing requirements such as:
- Mass spectrometric characterization including ion-mobility structural characterization, icIEF-MS, sequence variant analysis and proteomic based HCP identification
- Biophysical secondary and higher-order structure
- Functional binding and biological activity
- Product-related species identification
- Particle characterization
- Next-generation sequencing (NGS)
Analytical Testing and Characterization Services for Viral Gene Therapies
Developing analytical methods and testing viral vector modalities including adeno associated (AAV), lenti, adeno and retro viruses requires expertise and leading-edge instrumentation. Benefit from capabilities that are comprehensively tailored to your requirements and timelines including:
- BSL-2 analytical facilities
- Leading-edge capabilities
- Method transfer
- Method optimization
- Biological, physiochemical, and biophysical characterization
- Development of customized methods including bioassays and viral titer
- Phase-appropriate validation
- Stability indicating properties/forced degradation
- cGMP raw material, in-process and release testing
- cGMP stability studies
- Reference materials
- Comparability testing
Our capabilities and instrumentation cover the requirements for comprehensive cGMP Quality Control testing of a viral gene therapy product which include:
- Infectious titer
- Safety
- Mycoplasma
- Adventitious Virus
- Replication Competent Virus
- Quality
- Efficacy
- Identity
- Purity
- Aggregation
- Empty/full capsids
- Capsid content
- Residual process impurities
- Residual plasmids
- Stability
- Compendial methods
Quality Control Services
QC testing from raw materials to released Drug Substance and Drug Product is performed to ensure successful cGMP manufacturing operations.
Our analytical experts work proactively with our customers to plan and execute clinical and commercial testing. Our systems and procedures have been developed and maintained to certify cGMP compliance to applicable regulatory requirements and standards.
We serve patients by delivering quality products and services, in close collaboration with our partners for use in life-changing medicines. While building on a foundation of transparency and trust, we educate and empower all analytical development and quality control employees, to ensure cGMP compliance and agile ways of working. Quality is embedded in all we do.
As a global organization, we offer testing required to support the release of drug substance, drug product, finished goods, and stability studies across our facilities. Our Quality Control teams collaborate with Analytical Development and Method Transfer teams to ensure a rapid and seamless transfer of analytical methods as programs progress from process development to cGMP manufacture or for programs transferred into our manufacturing network. Quality Control provides a comprehensive suite of testing services that measure standard and advanced biopharmaceutical quality attributes including validation, change-over, in-process controls, product, process impurity, microbiological safety and viral safety.
Within our network, QC is responsible for end-to-end services
These services include:
- Cell bank testing
- Viral and bulk harvest testing
- Raw material testing
- Environmental testing
- Microbiology testing
- In-process control and intermediates testing
- Release drug substance, drug product, and assembled device* testing
- Stability testing
*biologics only
Quality Control Laboratory Management entails the part of Good Manufacturing Practices which is concerned with sampling, specifications, and testing, and with the organization, documentation and release procedures which ensure that the necessary and relevant tests are performed in a controlled manner, that materials are not released for use, nor products released for clinical or commercial use, until their quality has been judged to be satisfactory. In addition, our QC testing is guided by a mature electronic Quality Management Systems (eQMS).
