Analytics

Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

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 new personal capillary electrophoresis system, Spectrum Compact CE, performs Sanger sequencing and fragment analysis.

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

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

Method-transfer kits help simplify analytical method transfer for global site certifications.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.

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

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

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.