Analytics

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

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

The company’s SLIM technology has been a part of the company’s accelerated growth by offering enhanced R&D analytics.

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

Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo.

Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.

Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Find connections to suppliers of the materials, equipment, and services you need to develop, manufacture, and distribute crucial therapies, treatments, and vaccines in the 2020 Pharmaceutical Technology Buyers' Guide.

Enhanced sensitivity and ultra-high detection speed provide improved robustness and operability.

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

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.

Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

Advanced analytics streamlines continuous manufacturing by providing improved insights to data.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

The company recently launched its OmniTop Sample Tubes adjustable volume sampling system, a single-use system that allows for exact sampling.

The new filters extend column life and reduce contamination while simplifying sample preparation.

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

A comprehensive turnkey system based on LabVantage’s laboratory information management system platform allows laboratories to implement COVID-19 biobanking, testing, and research.

The company has expanded capabilities for aggregate analytics to include dynamic light scattering.

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.

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.