Search results for " potency"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Critical quality attribute identification/assay development: Identify and develop assays for critical quality attributes, potency assays—overestimate testing needs!
Methods/equipment qualific…
Article
Impurity Testing of Biologic Drug Products
Binding or potency assays, however, require the selection of suitable antibodies or modification of detector cell lines. Non-therapeutic host cell proteins can also present a considerable challenge to…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Characterization of binding events is essential for confirmation of CQAs, plays a vital role in forced degradation studies, and can either complement or form the basis for potency assays. Binding assa…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
As the molecule progresses through development and more is learned about the relationship between product attributes and their impact (or non-impact) on potency, pharmacokinetics (PK), or safety, thes…
Article
Preclinical Evaluation of Product Related Impurities and Variants
This is followed by routine analysis using an array of tests (In vitro binding assays, in vitro potency assessment, pharmacokinetics, pharmacodynamics, toxicity assessment). The data from these studie…
Article
Tackling Analytical Method Development for ADCs
The critical properties for ADC characterization include target site-specificity and binding properties, stability of the linker and drug species, drug potency and free drug, site(s) of conjugation, D…
Article
Virus-like Particles as Therapeutic Moieties of the Future
These assays are crucial for ensuring correct downstream application of VLPs and determining the potency of the preparation. Both in-vivo studies in animal models and in-vitro studies using methods su…
Article
Witnessing Major Growth in Next-Generation Antibodies
…ere intravitreal injection volumes are limited requiring small molecular mass therapeutics with high potency. Application bispecific antibodies are also being applied to diseases of the central nervo…
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Quality by design for biotechnology products—part 1
The scope of this paper is limited to well-characterized protein products, in which the natural molecular heterogeneity, impurity profile, and potency can be defined with a high degree of confidence. …
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
…lar therapies, regulators and manufacturers alike face continuing challenges for ensuring consistent potency, purity, and identify of these complex therapies. More than 100 experimental chimeric anti…