Results 141 to 150 of about 70,680 (286)
Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA [PDF]
In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market.
Adrian H. B. Gottschalk +2 more
core
Biotechnology Progress, EarlyView.This study established the first creation of a commercially available double GS knockout (DKO) from a single KO in CHO‐K1 cells, called CleanCut GS CHO using Cas‐CLOVER. When combined with the Harbor‐IN transposase system, CleanCut GS CHO cells demonstrated a highly antibody productivity.
Cintia Gomez Limia +7 more
wiley +1 more source
Organizational Scope and Investment: Evidence from the Drug Development Strategies and Performance of Biopharmaceutical Firms [PDF]
This paper compares the clinical trial strategies and performance of large, established ("mature") biopharmaceutical firms to those of smaller ("early stage") firms that have not yet successfully developed a drug.
David Scharfstein, Ilan Guedj
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Biotechnology Progress, EarlyView.Abstract The growing demand for cost‐efficient and flexible biomanufacturing has increased interest in process‐intensified downstream platforms. This study evaluates an intensified monoclonal antibody (mAb) purification sequence, where two unit operations traditionally performed in batch mode—Protein A capture and low pH virus inactivation (VI)—are ...
Mario Grünberg +8 more
wiley +1 more source
The Canadian Journal of Chemical Engineering, EarlyView.Abstract On the centennial of higher education in Chemical Engineering in Mexico, it is pertinent to revisit the key stages that have contributed to its consolidation as a vital discipline for the nation's scientific and technological advancement. Although the initial mission of chemical engineering education was primarily oriented toward the training ...
Agustín López Munguía +3 more
wiley +1 more source
The Effect of Contractual Complexity on Technology Sourcing Agreements [PDF]
Most research on strategic alliances ignores the underlying contracts that govern the terms of the relationship. This is problematic since it is how these contracts are structured that determines how firms will benefit from a relationship.
Hansen, Zeynep, Higgins, Matthew
core +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Maternal health remains a critical global concern, particularly in underserved populations and in low‐ and middle‐income countries where access to safe and effective therapeutics is limited. Despite the use of medications by most women during pregnancy, the exclusion of pregnant and lactating women from clinical trials has resulted in significant data ...
Rachel K. Scott +7 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Human radiolabeled mass balance studies are crucial for comprehensively characterizing the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs, providing essential data for drug development, regulatory evaluation, and product labeling.
Jason Boer +24 more
wiley +1 more source
Market Perceptions of ESG Reputational Risk in the US Pharmaceutical Industry
Corporate Social Responsibility and Environmental Management, EarlyView.ABSTRACT Negative ESG‐related reputational events generate significant corporate risks, particularly within sensitive sectors such as the pharmaceutical industry. Using novel reputational data, this research investigates investor perceptions of the consequences of experienced ESG breaches among US pharmaceutical firms.
Erdinc Akyildirim +3 more
wiley +1 more source