Search results for "development"
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Coffman, Christopher Gallo, and Ranga Godavarti
ABSTRACT
In recent years, most pharmaceutical companies have focused on the development of monoclonal antibodies (mAbs). Increasing upstream t…
Article
Maximum Output Starts with Optimized Upstream Processing
Significant growth in the development and manufacturing of biologics—from traditional recombinant proteins and monoclonal antibodies (mAbs) to advanced multispecifics, antibody-drug conjugates, viral …
Article
Addressing the Complex Nature of Downstream Processing with QbD
… According to Gunnar Malmquist, principle scientist, Cytiva, QbD has become an integral part of the development process for the biopharma industry. “We notice that the interest to file according to t…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Given this inherent genetic flux, recombinant genes (or transgenes, also referred to as the expression construct) expressed in CHO cells—used for therapeutic bioproduct development—can be subject to g…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Development and manufacturing advantages for genetic vaccines
What makes genetic vaccines so attractive is the potential to establish platform solutions that allow the r…
Article
Reimagining Affordable Biosimilars
Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is undergoing a transformation from multi-billion-dollar blockbusters to personalized medicines. More than 300 active biopharmaceut…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
By taking a holistic approach to improving the analytical process, one can identify strategies to increase throughput and reduce development times and the costs of analytical methods. This article dis…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
Development of clear, regulatory approval pathways for biosimilars in emerging markets is creating large, additional opportunities for biosimilar mAbs. Education of physicians, pharmacists, and patien…
Article
Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…