Analytics

Is there a difference between a specification and a standard?

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

New algorithm and functions in Shimadzu’s LabSolutions software enable compliance with data integrity regulations.

The Nano-flow imaging particle analyzer from Fluid Imaging Technologies automatically image nanoparticles for identification.

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

The new building is protected by special construction against vibration to ensure accurate calibration of laboratory balances.

The company has extended its presence in the US market to support its growing business in the region.

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

Technology improvements in analytical testing tools have helped increase understanding of molecules and speed up development processes.

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

FDA works with industry on strategies for assuring high-quality regenerative medicines.

Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.

Drug repurposing, repositioning, and rescue can be faster, cheaper, and target more diseases than traditional drug discovery approaches.

Forced degradation studies can identify stability problems for drug substance and drug products.

Innovation speeds discovery, drives down costs, and improves productivity.

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.

Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.

FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

Gilead will gain a robust pipeline of cell therapy products, with one lead candidate, a CAR T therapy, anticipated to gain FDA approval in the fourth quarter.

AstraZeneca and Takeda will partner to develop and commercialize MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD).