Industry Insights

31. Drug Repurposing Advantages And Strategies

    Identifying new therapeutic uses for old, existing, or available drugs is an effective strategy in discovering or developing drug molecules with new pharmacological and therapeutic indications.

32. Benefit From Leveraging Perfusion Early In Process Development 4/5/2024

    By addressing the complex needs of cell culture from the start, organizations can take steps to optimize their process, ensuring they are maximizing productivity and product quality.

33. Challenges In The CDMO Market 11/4/2015

    If you look at the CDMO market holistically, it is clear that continued growth within the sector market remains strong. At the same time, the market is becoming more competitive, with pharma customers looking for a smaller number of best fit CDMOs that offer high value services that will help them satisfy a range of industry challenges. 

34. Making Good Decisions When FDA Investigators Come Knocking 7/18/2024

    Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

35. Enhanced Host Cell Protein Analysis In Biologics Manufacturing 2/21/2020

    iEnzyme-Linked Immunosorbent Assays (ELISAs) to monitor host cell protein levels are challenging. This article illustrates an enhanced anti-host cell protein antibody coverage analysis method solution.

36. Liposome Drug Delivery: Global Trends & Market Forecast 1/19/2024

    Liposomes possess the ability to encapsulate drugs of both hydrophilic and hydrophobic nature. They can be tailored to target tissues or cells, enabling precise drug delivery. Let's examine how it works, applications, and new market insights.

37. AI's Potential To Aid Multispecific Analytical Characterization 5/16/2025

    Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

     

38. Clinical Trials In The Era Of Precision Medicine: What Needs To Change? 7/11/2019

    Part 1 of this two-part article examined the implications the transition to value-based, patient-centric, precision medicine has for drug discovery, development, and deployment, particularly for clinical trials. Part 2 explores precision medicine in more depth regarding the tailored and targeted treatments that aim to match patients to medicines according to particular clinical, demographic, and lifestyle factors.

39. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

40. Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise 5/5/2021

    With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.