Drug Substance Analysis

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.

The agency published a guideline for the implementation of ICH Q3D.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

FDA publishes the final Q3D Elemental Impurities guidance.

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, spoke with Pharmaceutical Technology Europe about sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Shimadzu?s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS).

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

Revisions to the United States Pharmacopeia (USP) General ChapterHeavy Metals have been much discussed over the past decade.

FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.

In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products.

The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.