Found 266 results in Expert Content

Summary: From a virological safety standpoint, biopharmaceuticals have had an excellent safety record. This can be attributed to regulatory and industry initiatives that have worked synergistically...

Summary: Biologic therapy has revolutionized the medical treatment landscape. However, simplicity and ease of administration remains a challenge to achieve long-term patient compliance and optimal therapeutic outcomes. Given the high cost of biologic therapies...

Summary: The use of biosimilars in clinical trials is on the rise. Often tightly controlled or in short supply, sourcing the necessary drugs can be challenging. Given the variability of biosimilars, studies using these products are particularly at risk for supply-related delay and cost overruns unless proactively managed from the beginning...

Summary: The antibody-drug conjugate (ADC) field is in a transitional period. Here, experts from Catalent discuss how pre-clinical work is driving rapid evaluation of how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes...

Summary: Strategic analytical partnerships are important in the development of new pharmaceutical products, especially biologics. Here, Michael Merges, Catalent Biologics, and Brian Fahie, Biogen, discuss the growing need for partners who can provide niche technologies to accelerate development projects...

Summary: One of the current challenges with existing ADCs is the difficulty in creating conjugates with a uniform drug to antibody ratio and consistent payload placement on the antibody, both aspects which are paramount in creating consistent and predictable therapies...