Contract Analytical Services

SGS is investing in a new E&L lab in Navi Mumbai, India, that will provide testing services.

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.

KSL Biomedical announced their expansion into Canada with the acquisition of Pulse Scientific and the incorporation of KSL Biomedical Canada.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

There are some key questions that should be asked by both the sponsor company and the outsourcing partner before undertaking a method development project.

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

Developing bioassay methods requires a new approach for cell and gene therapy drug development.

Thought and foresight into method development stages can ensure costly errors and delays are avoided later on.

Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.

The sensitivity of droplet digital PCR helps manufacturers detect Mycoplasma contamination in AAV-based gene therapy products.

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.

Model-based approaches and digital analytics are improving flexibility at both the equipment and the manufacturing-line level.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.

The £500,000 (US$686,294)-investment in mass spectrometry support will accelerate biologics development and approval.

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.

Following a recent expansion at its Cambridge, MA, facility, the company now houses a new suite of cellular analysis platforms that enhance its exploratory capabilities into oncology, neuroscience, and rare diseases.

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development.

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.

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.

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

Outsourcing stability testing to full-service providers can offer comprehensive benefits to bio/pharma companies.