Biologics Analytical Services



Testing Solutions And Services (CMC)

Rapid, customizable, cost-effective studies

Laboratory Services

Catalent provides full testing capabilities to suit the needs of our clients’ programs.  A comprehensive offering of bioassays and technologies are available to suit your specific testing needs across multiple disciplines. These disciplines include Physical, Chemical, Cellular Biology, Molecular Biology, and Microbiological testing services for both GMP and non-GMP needs, as appropriate.

Lot Release Testing

With a wide spectrum of orthogonal testing/bioassays available, Catalent can provide all your physical, chemical, cellular biology, molecular biology, and microbiological testing to support GMP release testing of drug substance, drug product or intermediates, both clinical and commercial lots, against specifications on one site. Our Quality Assurance group audits each lot of material released for clinical or commercial supply.

Stability Testing

Catalent provides stability testing services to support clients’ biologics programs for their drug substance, drug product, and reference standards for both new chemical entity and biosimilar/biobetter.  With a wide spectrum of orthogonal testing/assays available at one site, state of the art stability chambers and comprehensive global regulatory knowledge, we can offer our clients a robust stability programs.

  • We can provide your physical, chemical, cellular biology, molecular biology, and microbiological testing to support each time point and study all on one site.
  • Catalent provides ICH, WHO, and ASEAN storage conditions with:
    • Temperatures ranging from -80C to 60C.
    • Humidity ranging from ambient to 90%. 
    • ICH Photostability Option 2 – light exposure and temperature control.
    • Thermal cycles and freeze/thaw exposures are also available.
    • Chambers available to customize to clients specific needs
  • Our state-of-the-art stability facility has:
    • Chambers that are fully mapped and qualified.
    • Chambers have monitoring with alarm notifications 24//365 Dual redundancy system for power sources and air handlers. 
    • Walk in chamber, reach in chambers, and controlled substance isolation available
  • Validated electronic scheduling and reporting documentation systems.  Reports that can be submitted for regulatory filings.
  • Validated sample traceability and inventory system.
  • Metrics driven performance with on-time delivery.
  • Regularly inspected by FDA, MHRA, DEA, and clients for regulatory compliance with exemplary inspection record.
  • A wide range of stability studies available.

For more details on our stability offerings, please see our Large Molecule Stability Program Information.

Reference Standards

Complete characterization and qualification of reference standard can be provided. Qualifications of reference materials can be performed under a protocol or a specification for use in GMP testing.

Reference standard programs allow for clients who store reference materials with Catalent to receive advance notice when approaching expiration or retest date, giving ample time to establish new expiry/retest date, therefore, limiting any impact to testing needs.

For information on Catalent’s support of reference standard stability programs, please see Stability Testing.

See Analytical Techniques for a listing of capabilities offered to support Reference Standard characterization/qualification.

Characterization

With our extensive experience and breadth of capabilities, Catalent is well positioned to provide characterization to support the development of clients’ molecules.  Using various physical, chemical, cellular biology, molecular biology techniques, we can provide a robust orthogonal approach to structural and functional characterization.

See Analytical Techniques for a listing of techniques available to support characterization needs.

Biosimilarity

Catalent offers orthogonal strategies to support complete characterization and testing (i.e Lot comparability) of biosimilars and respective innovator.  Strategies include evaluation of the following attributes:

  • Structure and sequence
  • Shape/Higher Order Structure
  • Bioassay
  • Activity
  • Size
  • Purity
  • Surface charge
  • Carbohydrate analysis
  • Identity
Ad Hoc Testing

In addition to full program solutions, Catalent can provide individual or one-off testing service to complement clients’ testing needs.  We offer testing services over the spectrum of physical, chemical, cellular biology, molecular biology techniques.

See Analytical Techniques for a listing of techniques available to support testing and characterization needs.

Investigational Study

Catalent can aid you in your investigation, both manufacturing and analytical.  With the comprehensive and diverse analytical tools available, including of physical, chemical, cellular biology, molecular biology techniques, we can support variety of investigational needs  including, but not limited to, the following examples:

  • Impurity identification
  • Cell line conformation by gene sequencing
  • Product gene conformation
  • Post-translational modification
  • Molecule-molecule interaction by binding study

See Analytical Techniques for a listing of techniques available to support investigational testing needs.

In-Process Manufacturing / Formulation Support

Catalent provides testing to support manufacturing in-process testing and to support formulation development.  Testing capabilities provide support in timely manner to minimize impact to the manufacturing processing or development activities and include, but not limited to:

  • In process quality control checks
  • Formulation screening
  • DNA clearance
  • Process related impurities, e.g. host cell proteins

See Analytical Techniques for a listing of techniques available to support manufacturing processing and formulation screening activities.

Post Packaging ID

For support of packaging activities, Catalent can provide packaging ID testing.  Whether clients’ clinical or commercial supply is packaged at our Catalent packaging facilities (Kansas City and Philadelphia) or client chooses to use alternative packaging services, post packaging ID testing can be conducted to meet clients’ timeline needs.

Process Validation Support

Catalent can provide analytical support for process performance qualification.  We work with our clients and their timelines to ensure the Process Validation activity has robust and timely analytical support.

See Analytical Techniques for a listing of techniques available to support process validation activities.

Extractables / Leachables

Extractable / Leachable evaluations are an important part of a products filling process.  Catalents’ dedicated Extractable / Leachable group have extensive expertise to support this critical activity.

See Analytical Techniques for a listing of techniques available to support process validation activities.

Viral Clearance

An important step in demonstrating the safety of your biopharmaceutical product is validating the capacity of key process steps to remove or inactivate virus.  Catalent can help you choose the best pathway and steps to evaluate in order to assess the viral clearance potential of your manufacturing process. We will help you select the appropriate viruses to use and design GLP-compliant studies.

  • When evaluating a viral inactivation step (such as solvent/detergent, pasteurization, or dry heat), we make sure that the kinetics of inactivation is determined.
  • When evaluating a viral removal step (such as chromatography or nanofiltration), we ensure that infectivity balance is demonstrated.
  • We use high titer virus stocks so that the maximum clearance for your process step can be demonstrated. Validated infectivity assays are used to evaluate samples in real time.
  • We can also perform your entire study or let you use one of our dedicated client labs to do the processing while we perform the virus assays. While visiting Catalent, we can provide you with an office with telephone and data ports.