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Analytical CMC support

What is at the core of every successful pharmaceutical development program?  Accurate characterization, low-risk method development, and assured product stability.  You need a trusted partner with wide-ranging experience in analytics, product development, regulatory requirements, and validation, and an ally who can meet all your CMC needs. 

At Envigo, our CMC analysts are experienced in developing analytical techniques that are qualification-ready and suitable for GMP operations.  With decades of experience in operating a GMP quality environment, you can feel confident in Envigo’s qualification and validation expertise at all phases of your product’s development.  

Envigo CMC Services include a wide range of non-GXP biopharmaceutical development studies including the following:

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An essential component of any biopharmaceutical development program is analytics.  To be able to manufacture, release and demonstrate stability, a biopharmaceutical requires a range of appropriate analytical techniques that are robust, reproducible and capable of operating in a GMP environment.  Envigo CMC services, with our wide-ranging experience in GMP release and stability testing can provide for all your analytical development needs, whether they be for physicochemical analysis or bioassays. 

Envigo CMC services are able to deliver a comprehensive range of protein characterization techniques that can provide data on primary structure and post-translational modifications, higher order structure, and quaternary structure/aggregation.  Recognizing the complexity of protein structures, our analytics are designed to provide you with a comprehensive understanding of your biopharmaceutical molecule whether your product is in discovery/pre-clinical development or more advanced in the development pipeline.

Envigo CMC services has extensive experience in providing immunological activity bioassays and ligand binding assays to provide a comprehensive antibody characterization package. Regulatory authorities require that immunological effector function be evaluated to determine whether the mechanism of action will have an impact on the product safety and efficacy.  Specifically they require ADCC, CDC and cytotoxic properties along with Fc receptor and Complement C1q binding activities to be evaluated. With this extensive list of regulatory requirements, Envigo is here to support you and ensure you have everything you need for a successful biopharmaceutical regulatory submission.

At Envigo, we understand your need to de-risk process development at a very early stage by identifying the most suitable molecule for clinical studies from a physicochemical and bioactivity standpoint.  In support of the quality by design initiative promoted by regulatory authorities, our developability studies help you assess the stability profile of a biopharmaceutical candidate or rank the stability profiles of a series of similar biopharmaceuticals during pre-clinical or early in phase I development.  Our goal is to ensure that potential stability issues are flagged prior to any process development activities so that you can make a more informed decision on whether your product can progress to further development, be structurally modified to improve stability, formulated to improve stability, or deselected as a potential drug candidate.

As you reach that point in drug development where you must determine drug stability and the most suitable formulation for administration to the patient, Envigo can support you in the following ways:

  • Evaluation of a range of excipients
  • Characterization of the effect on protein structure and stability profile using a series of physicochemical analytical techniques
  • Stress testing with a range of factors
  • DoE approaches to make study size more manageable 

Leveraging this breadth of studies and a team of Envigo experts, we help you determine the formulation that will provide optimal stability and delivery characteristics.

To meet the regulatory expectation of any biopharmaceutical development program you need to characterize the drug substance/drug product stability through forced degradation and exposure to severe conditions (i.e., stress testing).  Studies may include the following:

  • Thermal denaturation
  • Humidity
  • pH acid/base
  • Ionic strength
  • Freeze/thaw
  • Oxidation
  • Light
  • Mechanical shear 

At Envigo, we can help you determine the intrinsic stability of your product and the degradation pathways.  We also enable you to identify and elucidate the structures of degradative products and establish which analytical techniques are truly stability-indicating.

To improve the success rate for your biologic compound in development, you need to comprehensively understand the pathology of the specific disease, and you need to identify and validate appropriate biomarkers that can offer more effective proof of therapeutic concept.  Whether you need in vitro or in vivo analysis, Envigo, with its extensive experience and expertise in cell and animal based assays, is the ideal partner to secure the potential for your biologic product.

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