Our DPS team is highly skilled in the development and execution of analytical methods for drug products of biopharmaceuticals including standard monoclonal antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates, and vaccines, as well as viral-and cell-based therapies.
The service offerings comprise the complete array of development activities of analytical methods that may be required for a parenteral drug product, ranging from:
- Developing and applying purity methods (size, charge based) such as SE-HPLC, RP-HPLC, iCE280 and CE-SDS
- Developing and applying identity methods
- Developing and applying content (concentration) methods
- Developing and applying bioassays (ELISA, cell-based, other)
- Pharmacopeial testing methods including pH, osmolality, extractable volume, subvisible particles, visible particles, color, clarity, density
- Release and real-time and accelerated stability testing of drug products for GLP supplies or clinical GMP material
- Regulatory support for drug product sections IND/IMPD, BLA/MAA documentation
- Trouble shooting
- Addressing special topics and challenges, including identification of particulates, characterization of particles e.g. in the subvisible or submicron range, surfactant content and degradation, extractables/leachables and product characterization and comparability, peak identification
- Design of adequate control strategy and specifications
Our DPS team has technical expertise in analytical development and quality control (QC). The analytical development and QC team offers specialized contract laboratory services including:
- Drug product development (R&D) and GMP (QC) release & stability testing
- Physical and chemical analytical laboratory services
- Forensic chemistry including:
- submicron and subvisible particle characterization
- particle identification
- extractable and leachable characterization
- excipient (e.g. surfactant) degradant characterization
Drug product QC release and stability testing is supported by analytical method development and cGMP drug product stability testing according to ICH guidelines. The drug product QC team can help to define shelf-life, specifications and develop a drug product control strategy for IND/IMPD or BLA/MAA, and design quality-by-design and breakthrough therapy submissions.
Our analytical team of experts is experienced to design appropriate analytical methods, ensuring a compliant method panel, understanding method capabilities including method validation, and performing release and stability testing. Our experts can support most challenging projects and understand requirements and typical requests from health authorities globally.
Our DPS team works closely with the drug substance sites and other analytical centers across the Lonza network enabling an integrated and high quality one-stop-shop from a single service provider.
All services are available as standalone services.