Validation services

57 Results

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Frontage Laboratories | 01-Dec-2019 | Technical / White Paper

Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed,...

How to Avoid Surprises in Small-Molecule Drug Development Programs

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent...

Validating The Simoa Technology

Frontage Laboratories | 01-Oct-2019 | Technical / White Paper

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...

Assessing Pre-Existing Antibodies in Biotheraputic Development

Frontage Laboratories | 21-Aug-2019 | Technical / White Paper

Immunogenicity is the leading reason that biologics fail in clinical trials, and thus it has become imperative for drug development programs to include...

The Truth about Physician Referrals and Clinical Trials

BBK Worldwide | 24-Jul-2019 | Technical / White Paper

Despite growing evidence, the myth that physicians won’t refer patients to clinical trials persists, perpetuated by the belief that they fear losing their...

Survey Report: State of the global pharmaceutical contract services industry 2018

William Reed | 11-Jul-2018 | Research Study

In May 2018 Outsourcing-Pharma.com, in association with InnovoCommerce, conducted its second annual ‘state of the industry’ survey on its user base of...

The Power to Make, A Virtual Tour

Althea | 24-Mar-2017

You have the power to make a difference. To make new therapeutics that improve quality of life and inspire a healthier world. To do this, you need a manufacturing...

Cleaning Validation - What do you need to consider to ensure a successful outcome?

RSSL | 14-Jun-2016 | Technical / White Paper

The data used to determine the success of a cleaning validation is built upon both the effective evaluation of the manufacturing plant and the robustness...

Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D

Butterworth | 26-May-2016 | Technical / White Paper

The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, meaning the final...

Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD

Butterworth | 24-Sep-2015 | Technical / White Paper

The classic Modified Atmosphere Packaging (MAP) application, in the pharmaceutical industry, uses medical grade nitrogen to purge atmospheric oxygen and...