Biopharmaceutical Analysis

Automation is one asset that benefits cell harvesting by cutting out laborious manual steps and minimizing contamination.

Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.

Manufacturers should consider the benefits and risks of contract packaging for stability studies.

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

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.

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

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.

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

Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.

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

Gene therapy products present a unique set of challenges for the control of host cell protein impurities.

Sophisticated analytical technologies are complementing traditional approaches in the identification of residual process-related impurities of biotherapeutics.

Microfluidic Modulation Spectroscopy is a recent innovation in infrared spectroscopy techniques that improves elucidation of secondary protein structure.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

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.

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

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

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.

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

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

PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.