Test Methods
A key to successful navigation of pharmaceutical development from initial concept to FDA approval is developing and validating appropriate, product-specific test methods. Analytical test methods must address phase-specific requirements for the quality, purity, identity, and potency of a biopharmaceutical product. Typically, biologics require product-specific methods. The most significant test method for biologics is the potency assay. Results from potency assays and other test methods support key decisions regarding movement of the product through the pipeline to the next phase, including stability and release of product. Our expertise at Gwen Wise-Blackman Consulting, LLC will assist with the steps required to select or design test methods that are suitable for each phase. We provide expertise from concept through validation and testing of samples to support product development.
Technology transfer
We will guide the process of transferring technology either at your site or at an independent laboratory to manufacturing or test sites where test methods are implemented.
development / qualification / validation
From initial concept to validation we will prepare timelines and protocols to drive completion of test methods suitable for sample analysis.
ligand binding assays
Ligand-binding methods are necessary to test preclinical and clinical samples for the concentration of biopharmaceuticals in biologic media. These methods are also useful to determine the presence of host cell protein and other potential contaminants present during the manufacturing and purification process. Our expertise will help ensure methods based on ligand-binding techniques are appropriately designed and validated for their intended use.
cell-based potency assays
The relative potency assay is the most important method for biologics. Cell-based methods are known for the potential to exhibit high failure rates. However, with proper controls in place, cell-based potency methods can be consistent and reliable, providing necessary data in a timely manner. We will work with your lab or CRO to develop and validate a cell-based relative potency method with an expectation of a low failure rate in the production setting.
cell banking guidance / evaluation
Cells are a crucial component of the potency test method. Creation of the cell bank that maintains product-specific characteristics is an important prerequisite for successful implementation of methods that support development of biologics. We will provide guidance on tests necessary to characterize the cells prior to banking and direction to qualify the cell bank prior to use.
Pharmacokinetics
Data documenting the concentration of large molecule therapeutics in preclinical and clinical samples is required in support of applications to regulatory agencies. The quality of the validated method assures reliable results. Our goal is the appropriate validation of test methods that provide the necessary sensitivity in each biological matrix.
review of training protocols
During technology transfer, training of staff at secondary sites may be necessary. Designing the protocol-driven steps to assure success is essential. Analysts implementing the test methods must clearly understand the methods. In addition, poorly written methods often lead to differences in implementation and results. Hands-on experience with complex methods and transfer of technology between laboratories is a definite asset when reviewing methods and training protocols.
anti-drug antibodies / NEUTRALIZING ANTIBODIES
Immunogenicity is a significant concern with biopharmaceuticals. Immune responses to biologics have the potential for a negative impact on efficacy, up to neutralization. Developing screening test methods, confirmatory methods, and neutralizing antibody assays are necessary components of product development for biologics.