Analytical testing, QC

Generic method approach for determination of residual solvents in active pharmaceutical ingredients by gas chromatography

Content provided by Almac Group | 29-Nov-2023 | White Paper

Solvents are defined as organic chemicals that are used to dissolve components. They are used during the manufacture of drug substances and can also potentially...

dPCR Case Study

Content provided by CellCarta | 08-Aug-2022 | Case Study

Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring...

CellCarta - Mapping Precision Medicine

Content provided by CellCarta | 17-Jan-2022 | Product Presentation

At CellCarta, we’re dedicated to working with our partners to further the limitless potential of precision medicine. Our broad technology offering is designed...

Maximizing Drug Formulation for First-In-Human Trials

Content provided by Altasciences | 13-Dec-2021 | Case Study

The manufacture of a drug product for clinical trials is of critical importance. The formulation, manufacturing, and assessment of a drug candidate during...

INDENA’S CUSTOM DEVELOPMENT AND MANUFACTURING SERVICES FOR APIS AND HPAPIS

Content provided by Indena | 08-Nov-2021 | White Paper

Indena’s Custom Development & Manufacturing Organization services offers a full range of manufacturing capabilities for pharmaceutical ingredients....

Advanced Analytics Driving Interactive Data Exploration in Study Teams

Content provided by PerkinElmer | 15-Jul-2021 | White Paper

At Novartis, TIBCO Spotfire® enterprise analytics is a key tool for interactive graphical data analysis for preclinical and clinical studies. Using interactive...

Solutions That Solve Common CNS Study Challenges

Content provided by Signant Health | 15-Jul-2021 | Product Brochure

The clinical development process for central nervous system diseases is scientifically and medically complex.

Exploring the Intricacies of the Immune System: A Practical Guide to Immune Monitoring Across Therapeutic Interventions

Content provided by Precision for Medicine | 01-Feb-2021 | Insight Guide

Immune monitoring has become an essential strategy for understanding, predicting, and monitoring the response of the immune system to therapeutic interventions....

Has EDC Kept Up With Changes In Clinical Trials?

Content provided by Oracle Health Sciences | 14-Dec-2020 | White Paper

In just a few decades, clinical trials have changed dramatically. Twenty years ago, most of the data used in clinical research was entered on paper, but...

Liver Disease Capabilities

Content provided by Q² Solutions | 01-Oct-2020 | Clinical Study

We integrate therapeutic insights, state-of-the-art technologies, best-in-class methods and quality systems to optimize NAFLD & NASH study design,...

CAR-T Cell Therapy

Content provided by Q² Solutions | 01-Sep-2020 | Clinical Study

Cell therapy involves the transfer of genetically altered cells into a patient. As a global central laboratory services organization, we provide testing...

The impact of PAT tools for aseptic manufacturing processes

Content provided by Telstar Life Science Solutions | 29-Jun-2020 | Case Study

Telstar case study. What is the impact of leading-edge innovative developments on the process analytical technology field for pharmaceutical systems and...

Laboratory Solutions for COVID-19 Clinical Trials

Content provided by Q² Solutions | 10-Jun-2020 | Clinical Study

As a leading laboratory services organization for trials across the globe, we are proud to partner with clients to support COVID-19 clinical trials. Our...

Q2 Solutions: Corporate Brochure

Content provided by Q² Solutions | 17-Apr-2020 | Product Brochure

We are an innovative, progressive and responsive partner with the global experience, medical expertise and focus on quality that is integral to drug, medical...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Content provided by Baxter BioPharma Solutions | 01-Mar-2020 | White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Content provided by Frontage Laboratories | 01-Dec-2019 | 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

Content provided by Frontage Laboratories | 01-Oct-2019 | 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

Content provided by Frontage Laboratories | 01-Oct-2019 | 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

Content provided by Frontage Laboratories | 21-Aug-2019 | 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

Content provided by BBK Worldwide | 24-Jul-2019 | 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...

Stability Testing As a Quality Control Measure

Content provided by Frontage Laboratories | 19-Jun-2019 | White Paper

Stability testing is, in essence, a quality control process and is there¬fore a vital component of every phase of clinical development for both large and...

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

Content provided by 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...

Advancing therapeutics for myeloma

Content provided by Recipharm AB | 04-Sep-2017 | Case Study

Multiple myeloma is the second most common blood cancer in the world and despite survival rates increasing over the last decade, there remains a requirement...

Survey Report: State of the Global Pharmaceutical Contract Services Industry 2017

Content provided by William Reed | 27-Jul-2017 | Application Note

In May 2017, Outsourcing-Pharma.com conducted its inaugural “state of the industry” survey of its user base of pharmaceutical industry professionals, including...

The Power to Make, A Virtual Tour

Content provided by 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...

Excellence in Pharmaceutical Analysis

Content provided by Butterworth | 16-Sep-2016 | Data Sheet

Butterworth specialise in Quality Control Analysis, Method Development, Validation & Stability Testing of Raw Materials, API, Finished Product and...

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

Content provided by RSSL | 14-Jun-2016 | 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

Content provided by Butterworth | 26-May-2016 | White Paper

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

Data Mining At The FDA

Content provided by Oracle Health Sciences | 20-Apr-2016 | White Paper

The FDA has recommended the use of data mining to the drug industry, and their new Data Mining at FDA white paper summarizes their past and current data...

How did 2015 unfold in specialty logistics?

Content provided by World Courier | 07-Dec-2015 | Case Study

It’s time to look back and see how our predictions for this year fared, and take another look at the things we have written about since then.We examine...

7 Common Myths about QP Training Debunked - A Guide for Senior Managers

Content provided by RSSL | 14-Oct-2015 | White Paper

The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law. Every holder of a relevant Manufacturers Authorisation (human...

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

Content provided by Butterworth | 24-Sep-2015 | White Paper

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

Analytical Solutions for the Combination Medical Device Development Process

Content provided by RSSL | 02-Jul-2015 | White Paper

Billions of patients worldwide benefit from a diverse range of medical devices. The global medical device market in 2011 was approximately $300 billion...

10 Proven Ways to Reduce the Cost of Clinical Trials

Content provided by Merge eClinical | 24-Jun-2015 | Clinical Study

Trimming your study budget is a good thing, right? When you can cut costs without compromising data integrity or accuracy, that's usually a positive....

Discover the benefits of collaborating with your central lab partner early in protocol development

Content provided by ACM Global Central Laboratory | 19-May-2015 | Clinical Study

Until recently, sponsors and CROs engaged their central laboratory simply for routine safety testing. However, as clinical trial protocols have grown in...

Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Delivery, Storage and Analysis.

Content provided by Butterworth | 12-May-2015 | White Paper

Samplestorage, handling anddelivery are as important in the determination of residual solvents as the analysis itself. This paper provides practical advice...

How Sponsors and CROs Benefit From EDC Efficiencies

Content provided by Merge eClinical | 01-Apr-2015 | White Paper

Intense competition in the prescription drug market is driving pharmaceutical companies to expedite their drug discovery and development processes. Pharmaceutical...

The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing

Merck KGaA, Darmstadt, Germany | Recorded the 09-Apr-2015 | Webinar

Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard...

A Method to Meet the New Ph Eur Ninhydrin-Positive Substances Requirement

Content provided by Butterworth | 27-Jan-2015 | White Paper

The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination of Ninhydrin-positive substances,...

Considerations When Performing an Intact Mass Analysis of a Monoclonal Antibody by LC-MS

Content provided by Reading Scientific Services Limited | 23-Oct-2014 | White Paper

Monoclonal antibodies are one of the most common types of biopharmaceuticals. Knowledge of an antibody’s molecular weight is essential; if this differs...

5-step guide to Temp-control using passive systems

Content provided by World Courier | 20-Oct-2014 | Application Note

Maintaining the strict temperature parameters required to ensure product stability is relatively straightforward in the plant or laboratory setting, where...

7 Common Myths about QP Training Debunked : A Guide for Senior Managers

Content provided by Reading Scientific Services Limited | 11-Sep-2014 | White Paper

The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK...

Temperature-Controlled IMP Distribution Challenges

Content provided by Almac Group | 04-Aug-2014 | White Paper

UNDERSTANDING THE CHALLENGES OF TEMPERATURE CONTROLLED INVESTIGATIONAL MEDICINAL PRODUCT DISTRIBUTION IN EMERGING MARKETSTemperature deviation within the...

Analysis of Biopharmaceuticals to Conform to ICHQ6B

Content provided by RSSL | 24-Jul-2014 | White Paper

Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by...

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

Content provided by RSSL | 19-Jun-2014 | White Paper

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical...

Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection

Content provided by ACM Global Central Laboratory | 17-Jun-2014 | Clinical Study

Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected...

Industry leading titers of protein in E.coli

Fujifilm Diosynth Biotechnologies | Recorded the 28-May-2014 | Webinar

The development of large scale E. coli expression systems can be rate limiting in process development.  Fujifilm's pAVEway™ system combines innovative...

Elemental Impurity Analysis in Pharmaceuticals

Content provided by Butterworth | 06-May-2014 | White Paper

A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical...

The Promise and Challenge of Adaptive Design: Oncology Trials

Incorporating adaptive design methodologies into clinical trials can reduce costs while maintaining trial integrity.  Learn how these design strategies...

Preparation of Pharmaceutical Samples for Metals Analysis

Content provided by RSSL | 28-Nov-2013 | White Paper

With proposed changes to elemental impurities requirements for pharmaceutical products currently being reviewed, spectroscopic techniques for metals analysis...