Contract Analytical Services

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.

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

CMOs and CDMOs expanded their services and facilities in 2019 and early 2020.

Drug development contract services company PPD announces initial public offering.

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.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

CMOs and CDMOs expanded their services and facilities in the summer of 2019.

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

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

Key considerations when searching for an analytical service provider include workflow, hardware, and regulatory support.

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.

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.

The acquisition is expected to strengthen SGS’s agriculture, food, and life business in the United States.

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

Cambrex’s expanded quality control laboratory supports generic API development.

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

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.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

The expansion includes a new R&D laboratory and the installation of a 12,000-liter reactor at one of the company’s manufacturing facilities on its Paullo site in Milan, Italy.

Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.

Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.

The acquisition would strengthen Charles River’s contract research capabilities.

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.

Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.