Changing the future of data

whitePaper | June 5, 2022

The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases.

whitePaper | May 10, 2022

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 19 information 20 submitted for FDA assessment as part of original new drug applications (NDAs) under section

whitePaper | December 22, 2022

Determining the physical titer of viral vectors has typically been accomplished using digital droplet PCR (ddPCR). Droplet-based methods, however, are challenged by matrix effects and long analysis times (up to 7 hours).

whitePaper | November 8, 2022

Using experienced-based best practices and documented tools, ICON has conducted over 63 CGT trials across multiple therapeutic areas from haematology-oncology torare and orphan diseases.

whitePaper | December 16, 2022

Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies that consist of two distinct binding domains.

whitePaper | November 22, 2022

Specializing in oncology, anti-infective and complex formulations, Pfizer Melbourne provides end-to-end services from development through to commercial manufacture of sterile dosage forms.