Industry Insights

41. Should We Refocus On The Product, Then Engineer The Process? 10/14/2025

    Logic behind the "process is the product" refrain collapses when you accept that starting material is non-uniform by design. These experts want to rethink a tired cliche.

42. Enriching Sterile Fill/Finish Services With A Patient-Centric Approach 12/18/2025

    Through early collaboration and advanced aseptic technology, organizations can overcome complex formulation challenges to ensure safe, effective treatments reach patients more efficiently than before.

43. Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices 12/11/2023

    The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.

44. May 2026 — CDMO Opportunities And Threats Report 6/16/2026

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

45. FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III

    The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.

46. Improving Therapeutic Protein Efficacy Through Charge Profile Adjustment 9/10/2024

    By adequately measuring charge variants early in development and implementing effective control strategies, developers can mitigate risks and ensure the safety and efficacy of their mAb products.

47. Pharmaceutical Company Innovation By The Numbers 4/6/2023

    Clarivate has published its 2023 list of the Top 100 Global Innovators, identifying the companies and institutions globally that have pushed the boundaries of technology and applied knowledge the furthest. To define “innovation” in this context, Clarivate uses global invention data, which includes patent applications and issued/granted patents.

48. Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite 9/18/2025

    FDA Commissioner Marty Makary has promised to end the so-called "double standard" of announced overseas inspections. Does the agency have the resources?

49. Using The QTA To Align Data-Integrity Expectations 4/17/2019

    Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). The principles described in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities.

50. Surface Plasmon Resonance for Biomolecular Interaction Analysis 4/15/2025

    Explore how uncovering molecular interactions can drive breakthroughs in disease understanding, drug discovery, and therapeutic innovation.