
The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

Establishing extractable and leachable studies for complex biotherapeutic molecules poses new challenges for analytical assessment.

A recent innovation in infrared spectroscopy, Microfluidic Modulation Spectroscopy has been shown to improve characterization of secondary protein structure.

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

New challenges arise in extractable and leachable studies for cell and gene therapy products.

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

Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market.

Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.

Through a partnership with the University of Hertfordshire, Ziath discovers means of using AI to detect empty wells in sample tube racks.

Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.

Sciex’s recently launched accurate mass instrument, the ZenoTOF 7600 system, offers novel ion fragmentation and increased sensitivity for life science research and biotherapeutic development.

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

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

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

The future pipeline of complex novel biotherapeutics will require new approaches to analytical assessment.

The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.

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

With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

Chalmers University researchers have developed a method to label and track mRNA molecules.

Thermo Fisher Scientific has introduced its new Quick to Clinic solution, which is designed to accelerate biologic drug development from discovery to the IND phase in a shortened period.

CatSci has opened its new Dagenham, UK-based laboratory, which is dedicated to analytical excellence.

The CYTRIX Microfluidic Hydrogel Kit is the first in Sphere Fluidics’ new range of 3D cell culture kits in partnership with ClexBio.

The new multi reflecting time-of-flight mass spectrometry platform from Waters delivers highest quality resolution at fast speeds.