Drug Substance

An active ingredient intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body; it does not include intermediates used in the synthesis of such an ingredient
References in periodicals archive ?
In addition, the final regulation also states that the manufacturer may reference a current USP-NF monograph, which could help satisfy the required description of the active ingredient or botanical drug substance in the TEA.
The US Food and Drug Administration (FDA) has given approval to US-based specialty biopharmaceutical firm Shire to take up the production of VPRIV drug substance (velaglucerase alfa for injection) at its manufacturing facility at 400 Shire Way, Lexington, Massachusetts.
a leading provider of global contract pharmaceutical drug substance development and active pharmaceutical ingredient (API) manufacturing services, is pleased to announce receipt of a 2014 Lilly Global Supplier Award.
Particle Size of Drug Substance and Product Content Uniformity - Theoretical Considerations
Lam brings to KaloBios more than 28 years of experience in biopharmaceutical manufacturing, including 17 years at Genentech, where he ultimately served as Global Head of Contract Manufacturing Operations, Commercial Drug Substance, for the Roche Group.
Biotech company Pharming Group NV ( Pharming ) announced today that it has received approval from the European Medicines Agency (EMA) for Sanofi Chimie to manufacture drug substance for Pharming s product Ruconest at their Aramon (France) site.
Conformia is currently working on a new case study focused on a large molecule drug substance with leading biotech companies.
The white paper, "Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product," focuses on what many consider the most critical part of a biological drug product's manufacturing life cycle: going from the purified bulk drug substance ("PBDS") to the sterile final drug product ("FDP").
When base catalysis of drug degradation occurs preferentially or exclusively, the stability of the drug substance may depend on its being kept in a somewhat acidic (low pH) environment.
The white paper, "Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product" focuses what many consider the most critical part of a biological drug product's manufacturing life cycle: going from the purified bulk drug substance ("PBDS") to the sterile final drug product ("FDP").
was named vice president, pharmaceutics, a new position responsible for managing pharmaceutical drug substance scale-up, manufacturing and dosage design and development, required for the company's development programs.
a leading GMP biopharmaceutical manufacturer, announced today that it has completed the manufacture and release of ActoGeniX' drug substance AG011 for use in a Phase II clinical trial with ulcerative colitis patients.