Biologics Archives | Pharma Lesson

Biowaiver Eligibility for Injectable Formulations

ByPharma Lesson February 22, 2025February 22, 2025 Reading Time: 2 minutes

For injectable formulations, biowaiver eligibility depends on several factors, including the type of injectable (solution, suspension, emulsion), formulation differences, and regulatory guidelines from agencies like the USFDA, EMA, and WHO. Here are the general biowaiver requirements for injectable projects: Biowaiver for Parenteral (Injectable) Solutions For biowaivers to be granted for injectables, the formulation must meet…

Formulation

Formulation Development Strategies for Biologics Product

ByPharma Lesson February 9, 2025February 9, 2025 Reading Time: 5 minutes

The formulation of biologics presents unique challenges due to their structural complexity and sensitivity to environmental conditions. This review explores critical aspects of biologic formulation, including stability considerations, excipient selection, and delivery systems. Additionally, biopharmaceutical factors such as absorption, distribution, metabolism, and excretion (ADME) of biologics are discussed. Recent advancements in formulation strategies, including novel…