Industry Insights

31. Challenges In Developing Effective Therapeutics Against Respiratory Syncytial Virus Infection 7/26/2022

    The approaches exist to safely test small-molecule antivirals, large-molecule biologics, and vaccines — moving development of RSV vaccines and anti-viral drugs in an exciting direction.

32. We Must Rethink The Solvents We Use For Peptide Synthesis 4/21/2025

    While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.

33. EMA Publishes Guideline On Quality Documentation For Medicinal Products 8/2/2021

    This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.

34. Economic, Operational Advantages Of SaaS For Life Sciences Manufacturing 6/25/2020

    Over the past decade, Software-as-a-Service has reduced TCO by 77% compared to on-premise apps. SaaS providers now offer systems designed to meet the needs of FDA-regulated companies.

35. Single-Arm Trials Use Real-World Evidence For Rare Disease Drug Development 3/1/2022

    In rare disease product development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Gain insight into the regulatory considerations for single-arm trials.

36. Quality Imperatives In Oral Solid Dosage Manufacturing: An Overview 5/2/2024

    This article overviews the critical aspects of OSD manufacturing and the importance of understanding and implementing regulatory guidelines within the context of quality.

37. From IND To NDA: The Role Of The Kilo Lab In A Seamless Scaleup 7/29/2025

    To derisk your manufacturing, work with an outsourcing partner that prioritizes the kilo lab as a space to develop a proven, robust, and reliable workflow from clinical to commercial scale.

38. A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS 3/5/2024

    Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

39. Leveraging Autoinjector Innovation To De-Risk Biosimilar Development 6/2/2022

    Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

40. FMEA Vs. System Risk Structures (SRS): Which Is More Useful? 9/24/2021

    In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?