Contract Analytical Services

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

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

The expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.

Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.

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

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

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

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.

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.

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

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

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.

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.

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.

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.

Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.

The companies will form a biometrics organization focused on delivering analytical solutions for drug development.

The acquisitions, totaling $50 million, are expected expand Aptar Pharma’s service offerings to support complex product development.

As SUS become prevalent in the biologics industry, the question of safety becomes increasingly important.

The companies will merge to offer a broader range of analytical data packages and regulatory support for biopharmaceuticals.

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

The partnership will enable the Applied Process Company (APC) and the National Institute for Bioprocessing Research & Training (NIBRT) to provide increased access to R&D and analytical services.

Alcami Biologics formed to meet market demands for biological drug development services.

A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.