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2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology

Cover: For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and has been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results, which were first shared at the 2020 ISPE Aseptic Conference.

Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12

Feature: The latest ICH guideline, ICH Q12, introduces regulatory mechanisms, such as established conditions (ECs), to simplify and expedite postapproval product variations and enable continual product improvement. As illustrated by this case study for a small molecule product, the appropriate use of established conditions can successfully narrow the technical and regulatory gaps that limited the realization of flexible regulatory approaches promised by the application of Quality by Design principles.

Special Report: COVID-19 Impact

Special Report:

  • Pharmaceutical Engineering® COVID-19 Impact Survey: How the Industry Is Responding
  • Engage with Health Authorities to Mitigate & Prevent Drug Shortages
  • Pandemic Preparedness & Business Continuity
  • How Vaccines Are Developed

Process Technology

TECHNICAL: Lyophilizer Instrument Calibration: Principles and Practices Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. A greater understanding of the science and technology of lyophilization drives improvements in calibration, which leads to better process control and increased confidence in achieving product quality.

In This Issue

Tracking the Journey of Barrier Technology
Features
2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its key results, which were first shared at the
Jennifer Lauria Clark
Insights
Women in Pharma® Editorial: Virtual Connections
How is your calendar looking these days? As I write this, we have all been living a bit differently today than we were one year ago. I’ll bet you have seen an increase in webinars, virtual trainings, and video conference calls, and likely having far fewer face-to-face interactions.
Message from the Chair: The Next Normal - Workforce of the Future
Insights
Message from the Chair: The Next Normal - Workforce of the Future
Since January, nothing has been normal. Nothing, especially when we try to compare it to anything we have experienced in the recent past. So how do we begin to move forward as the efforts of both the public and private sectors combine to offset the advance of the impact to businesses due to COVID-19?
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
Special Reports
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent engagement with health authorities is a powerful opportunity for drug manufacturers to...
How Vaccines Are Developed
Special Reports
How Vaccines Are Developed
Vaccine development is an intricate undertaking, which may involve numerous challenges from the initial process of identifying an antigen to the final steps of delivering and administering the licensed product. The COVID-19 pandemic has put a spotlight on the science of vaccine development. As the world awaits a vaccine for the coronavirus, manufacturers face unprecedented pressure to respond...
Achieving Vertical & Horizontal Integration in Pharma 4.0™
Features
Achieving Vertical & Horizontal Integration in Pharma 4.0™
Recent projects on serialization and track and trace help illustrate the concepts of vertical and horizontal integration. With vertical integration, the unique product identification information (serial number, lot, etc.) used by sensors and printers on the packaging lines is made accessible to the supply chain and regulatory hubs throughout the entire technology stack. With horizontal...
The Untapped Potential of AI &  Automation in Pharmacovigilance
The Untapped Potential of AI &  Automation in Pharmacovigilance
Between 2009 and 2019, the number of adverse events (AEs) for drugs and therapeutic biologic products recorded by the US FDA Adverse Event Reporting System (FAERS) increased more than 300%, from 490,032 to 2.19 million cases (as of 31 December 2019).US Food and Drug Administration. “FDA Adverse Events Reporting System (FAERS) Public Dashboard: Data as of December 31, 2019.”...
Article
InTouch
ISPE Briefs: ISPE Special Interest Group for Cybersecurity
ISPE has a new special interest group (SIG) to work on IT cybersecurity. The Special Interest Group was formed under GAMP®. A conversation with Jason Young of Silver Bullet Security, who heads the new group, provides details about the Special Interest Group.
Figure 1: Batch simulation using MVDA
Technical
Continued Process Verification in Stages 1–3
Continued process verification (CPV) as defined in the US FDA process validation guidelineUS Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download helps bring quality management and compliance in the pharmaceutical industry to the next level, but it has been challenging to...
Figure 1: Dry block instruments for calibration to 55°C (left) and 75°C
Technical
Lyophilizer Instrumentation Calibration: Principles & Practices
Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. Recently, focused attention has been given to control and monitoring instrumentation for lyophilization.
Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidance [
Features
Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12
The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019.