Drug Substance Analysis

Plasma-Based Antibody Therapies Battle Against COVID-19

June 01, 2020

BioPharm International

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

Building Better Bioassays

May 01, 2020

BioPharm International

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

Keeping Aggregation Under Control

April 07, 2020

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

USP Offers Support for COVID-19 Drug Developers

March 19, 2020

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

Stability Testing: The Crucial Development Step

March 02, 2020

BioPharm International

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.

Seeking Early Answers to Formulation Questions

March 01, 2020

BioPharm International

Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.

Meeting E&L Expectations

December 02, 2019

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

Samsung Announces Manufacturing Agreement with Ichnos Sciences

November 06, 2019

Through the agreement, Samsung will provide flexible business terms while offering full regulatory support and improved batch release from small to large scale.

Dealing with particulates or aggregates in biologics

September 01, 2019

BioPharm International

Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.

Putting Biopharma Stability Testing Under the Microscope

September 01, 2019

BioPharm International

Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.