Platform technology is gaining importance as regulators and industry seek tools to streamline regulatory approaches. In this article, we discuss how organizations might use platform technology in regulatory submissions to improve process efficiency for regulators and industry.

Global chemistry, manufacturing, and controls (CMC) postapproval changes (PACs) are still managed largely through fragmented, country-by-country processes that duplicate sponsor and regulator effort, increase cost, prolong implementation timelines, add supply chain complexity, discourage continual improvement, and delay patient-centric enhancements.

ICH Q12’s intent is to enable a holistic control strategy and provide regulatory tools for continual improvement over the product life cycle, thereby promoting innovation. However, slow implementation of ICH Q12 tools by regulatory agencies has created challenges for industry to fully use Q12 concepts in regulatory submissions.

Bioreactor contamination can be one of the most troublesome and costly deviations to resolve in a GMP manufacturing facility. That’s both because cell culture unit operations are inherently susceptible to contamination and because tracking down the source of contamination can be extremely difficult.

Physical temperature buffers function as low-pass filters on the thermal environment of pharmaceutical storage units and are widely used to dampen transient fluctuations and mimic product thermal behavior. This article presents a study that quantifies the limitations of fixed physical buffering and evaluates model-based buffering’s ability to address those limitations.

Pharmaceutical manufacturing’s digital transformation is constrained not by a lack of data, but by decision velocity: the speed, quality, and auditability of translating operational signals into compliant actions.

Quality professionals in all industries are heavily involved in root-cause analysis (RCA) and corrective and preventive action (CAPA) management. As artificial intelligence (AI) systems emerge to augment these quality functions, the industry faces a fundamental challenge: no comprehensive regulatory framework exists to govern AI application in GxP environments.

Spray drying has become a key enabling technology for developing amorphous solid dispersions (ASDs) to enhance solubility and bioavailability in poorly water-soluble drug candidates.

By adopting artificial intelligence (AI) and machine learning (ML), the life sciences industry can leverage dynamic systems, a completely new system design. These systems feature ML models that learn adaptively automatically from data, accommodating changing relationships between input and output over time.

Cell and gene therapies (C&GTs) offer a groundbreaking approach for disease treatment by targeting conditions at the cellular and genetic level, offering hope for previously untreatable disorders. As these therapies progress from clinical trials to commercial reality, manufacturing challenges—particularly the need for robust, scalable, and cost-effective production—remain a significant...

Mold contamination is one of the most persistent threats to cleanroom integrity in pharmaceutical manufacturing. This article highlights the sources, growth conditions, and pathways for mold ingress. It emphasizes the need for an integrated approach combining facility design, environmental monitoring, effective investigation, and robust cleaning and sanitization programs.

This article presents experiences from seven recent accelerated development program case studies. These experiences provide insights that could help companies progressing through accelerated development programs for products meeting unmet medical needs or significant therapeutic needs, such as those with anticipated Breakthrough Therapy (United States) or PRIME (European Union) designation.

This article examines the regulatory landscape governing artificial intelligence (AI) in quality-critical systems and distinguishes between algorithms, AI, and a nuanced middle category called smart systems. It explains how organizations can responsibly embrace advanced programmatic solutions while preserving the integrity of validated test methods and safeguarding patient safety.

Shelf temperature mapping is a critical component of lyophilizer qualification. The previous articles in this series explored the methods used to record the shelf surface temperatures (Part I) and designing an appropriate study (Part II). Interpreting a shelf temperature mapping study’s result is as critical to assessing uniformity as the temperature measurement, the study design, and the...

The promise of single-use technologies (SUTs) in biopharmaceutical manufacturing is as compelling as it is contradictory. Noted for accelerating process development, enhancing sterility, and enabling unprecedented manufacturing agility, SUTs have also introduced a less visible but mounting challenge: the steady accumulation of complex plastic waste.

Bulk powders inherently exhibit unpredictable flow in feeders, dosing machines, and packed machines under gravity's pull. Meanwhile, particle engineering co-processed excipients can be more versatile and economical compared to conventional ingredients in the continuous manufacturing of drug products.

In today’s pharmaceutical landscape, speed, compliance, and efficiency are no longer optional—they’re strategic imperatives. Yet for large capital expenditure (CapEx) projects, traditional paper-based commissioning, qualification, and validation (CQV) workflows remain a major bottleneck, consuming time, resources, and patience.

Radiopharmaceuticals account for many lifesaving diagnostic and therapeutic drug products in the market. These drug products, radioligand therapies (RLTs) in particular, represent a relatively novel modality and present multiple, unique challenges to manufacture, release, ship, and administer.

ASTM E2500, issued in 2007, has been the primary standard guide defining what is required to apply quality risk management (QRM) to achieve the qualification of facilities, systems, and equipment in support of validation and process validation. A major update was undertaken in 2024 to better align the guide with current regulatory and industry guidance and current best practice.

Schedule management faces challenges such as unrealistic deadlines, scope creep, resource constraints, and poor communication, often causing delays and cost overruns. Using tools like an interdependency matrix (IDM) with project management software tools like Microsoft Project improves accuracy, visibility, and control.

This article provides guidance on the best practices to adopt when preparing for an audit or inspection, with a particular focus on commissioning and qualification and the points to consider during the development of materials to explain a company’s individual approach to commissioning, qualification, and validation maintenance.

Categorization offers a useful starting point for assessing the risk of failure for individual software components, but it is not a validation checklist. Organizations must apply critical thinking to combine categorization with risk assessment and supplier assessments to appropriately scale life cycle activities and manage risk.