Pharmaceutical Engineering® Reader Picks for June

Room Differential Pressures in Facility Design: Fundamentals

The expectations for room differential pressures to maintain air quality in pharmaceutical facility design are consistent and well defined from a regulatory perspective. However, there is no common approach to the design, monitoring, or alarming of area differential pressures. This article explores differential pressure concerns in aseptic manufacturing, specifically cleanroom classes B, C, and D. READ MORE

Streamlining the Vein-to-Vein Process: The Future of Automated Cell Therapy Manufacturing

Cell therapies, especially autologous chimeric antigen receptor T cell (CAR T cell) treatments, are transforming personalized medicine, bringing new hope to patients with conditions once thought untreatable. However, the manufacturing processes for these therapies remain predominantly manual, presenting significant challenges in scalability, consistency, and accessibility. READ MORE

AI Maturity Model for GxP Application: A Foundation for AI Validation

Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many areas of the business world. The pharmaceutical industry and its GxP-regulated areas also want to use AI in a beneficial way. Several pharmaceutical companies are currently running digital pilots, but only a small fraction follow a systematic approach for the digitalization of their operations and validation. However, the assurance of integrity and quality of outputs via computerized system validation is essential for applications in GxP environments. If validation is not considered from the beginning, there is considerable risk for AI-based digital pilots to get stuck in the pilot phase and not move on to operations. READ MORE

Resilience for Cell Therapy Manufacturers: Five Strategies

For patients who depend on personalized medicine, turnaround time matters. However, moving quickly is difficult for cell therapy companies because designing personalized therapies presents unique challenges unknown in traditional biotechnology. In this article, the authors examine five strategies to help cell therapy companies develop resilience against these challenges, positioning themselves to reliably deliver what patients need. READ MORE

Continued Process Verification in Stages 1–3

Continued process verification as defined in the US Food and Drug Administration (US FDA) process validation guideline, “Guidance for Industry. Process Validation: General Principles and Practices” helps bring quality management and compliance in the pharmaceutical industry to the next level, but it has been challenging to implement in practice. This article describes an approach for implementing continued process verification through the core concept of design space based on online multivariate data analysis and Monte Carlo random simulation. READ MORE

Unlocking Advanced Therapy Medicinal Products (ATMPs): Reducing Cost as an Obstacle to Patient Access

ATMPs have the potential to treat life-threatening, incurable conditions. But access to these therapies remains challenging due to the nature of current ATMP manufacturing models. This article explores solutions, focusing on standardized processing and shared knowledge as gateways to automated, robotic manufacturing and decentralized production. READ MORE

Final Preparation of ATMPs at Point of Care

ATMPs, which include cell and gene therapy (C&GT) products, frequently require handling steps between quality control release and patient administration. These steps take place directly at the point of care and are especially critical for C&GTs with limited shelf life after preparation. READ MORE

ISPE’s International Council for Harmonization (ICH) Q12 Team Trains Singapore’s HSA on Regulatory Guideline

ISPE’s Q12 Implementation Team continued its series of training events with a well-attended course for Singapore’s Health Sciences Authority (HSA) in November 2024. The team, which is part of the ISPE Product Quality Lifecycle Implementation (PQLI)® committee, has been conducting training events worldwide to assist regulatory agencies in implementing the ICH Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” READ MORE

Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards

Controlling contamination in environments where biological medicinal products are handled is of paramount importance to ensure the safety of personnel, sterility of drug products, and protection of the surrounding environment. The application of vaporized hydrogen peroxide has emerged as a promising method for postproduction decontamination due to its ability to degrade biohazards into nontoxic byproducts. READ MORE

Cleaning Validation Program Maintenance in a Process Lifecycle Model

The process lifecycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation. The three-stage product lifecycle approach—design, performance qualification, and continued process verification—emphasizes that scientifically sound decisions are required in all process stages. Overall, the process life-cycle model provides a higher level of understanding, which ensures a more robust, complete process. This article discusses how to maintain validated cleaning procedures as part of a process lifecycle approach. READ MORE

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