… RV Mantri Drug Product Science & Technology, BristolMyers Squibb, New Brunswick, NJ,
United States RJ McCann AstraZeneca, Mt. Vernon, IN, United States M. Mehta US Food and …

This study aimed in understanding the degradation behaviors of an IgG 1 subtype therapeutic
monoclonal antibody A (mAb-A) associated with pH and buffer species. The information …

Lyophilization is an approach commonly undertaken to formulate drugs that are unstable to
be commercialized as ready to use (RTU) solutions. One of the important aspects of …

To support dose reduction, low dose of a monoclonal antibody (mAb) was required to be
administered via IV infusion at a concentration of 0.1 mg/mL. To achieve the target protein …

Understanding the behavior of tablet disintegrants is valuable in the development of
pharmaceutical solid dosage formulations. In this study, high-resolution magnetic resonance …

Most active pharmaceutical ingredients (APIs) are solid in nature and could exist in many
forms that vary significantly in their properties, leading to different physical, chemical, …

As the complexities of the pharmaceuticals needed to prevail over serious diseases continue
to grow, the need for technologies to enable their efficient storage and delivery are as …

Reactive impurities in excipients are often the attributed cause of drug product instability.
Development of an excipient and drug product control strategy requires detailed understanding…

The history of Indian seaweed research is not more than seventy-five years. The state of the
Indian seaweed resources was last reviewed in 1998 and subsequently lot of new …

Modeling approaches play a valuable role at various stages of development and life-cycle
management of biopharmaceutical products. In Quality-by-Design (QbD) paradigm, quality …