Risk Management

A Risk-Based Approach to Supplier and Raw Materials Management

Ensuring a continuous supply of safe medicines is a key objective for the pharmaceutical industry and health authorities alike. A critical component to that end is maintaining a reliable supply of qualified raw materials (RMs) used in drug production. However, changes in suppliers, their processes, their providers, and consequently the materials they supply can occur (for a number of reasons) at any time during the life cycle of drug production. A product-supply organization therefore must be prepared to address such…

Next-Generation Bioprocessing for Meeting Healthcare Challenges: The Role Single-Use Handling Systems Can Play

The rapid spread of contagious and lethal diseases worldwide has driven bioprocess suppliers to develop technologies for use in producing disease treatments and vaccines. Bioprocessors need to develop new biologics as well as rapid and reliable methods for bringing those treatments to commercialization. Implementing modular process solutions and single‑use handling systems in closed‑manufacturing processing is one approach to addressing those needs. Developing and discovering solutions for meeting global healthcare conditions is an evolving part of bioindustry. As points of reference,…

Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality

Cosponsored by CASSS (an International Separation Science Society) and the US FDA, the 17th CMC Strategy Forum was designed to explore the relationships between higher-order molecular structure and quality of therapeutic proteins and peptides, vaccines, and blood-derived products. Understanding those relationships is important to defining and controlling the critical quality attributes (CQAs) of biopharmaceutical products. The forum program highlighted the current state of the art for analytical tools used to monitor higher-order structure. Case studies demonstrating the effects of changes…

Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities

Single-use systems (SUS) consist of numerous plastic components derived from different suppliers. As such, they are prone to changes, including alterations in construction materials or modifications in manufacturing processes. Such changes may originate at the immediate supplier or farther back in the supply chain as a result of product improvements, process improvements, part discontinuation, or even business decisions such as manufacturing site relocation. Whether those changes are major or minor, managing their impact on biopharmaceutial processes and product quality often…

Manufacturing Strategies: BPI Theater @ Interphex 2015

Bill Hartzel (director of strategic execution for advanced delivery technologies, Catalent Pharma) 1:30–1:55 pm Reducing the Risk Associated with the Filling of Biologics with Advanced Aseptic Processing  Hartzel discussed leveraging “blow–fill–seal” (BFS) aseptic processing technology to reduce risks associated with biologics fill and finish. A number of drug recalls have been associated with microbial and particulate contamination of glass vials, problems that could be solved using BFS. Automation eliminates human intervention at this critical stage, driving out associated risks. Hartzel…

Challenges in Implementing Quality By Design: An Industry Perspective

In the fall of 2004, the US Food and Drug Administration (FDA) published a final report entitled Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach (1). This publication set the groundwork for a prospective risk‑based approach to pharmaceutical product development. It was published on the heels of a November 2003 agreement between the FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to develop an internationally harmonized plan for developing…

Fundamental Strategies for Viral Clearance Part 2: Technical Approaches

Viral safety is required for biologics manufactured to treat human diseases. Although significant improvements in ensuring viral safety have been made over the past few decades, “zero risk” of viral contamination is a myth. Viral contamination risk can be carefully managed by screening raw materials, testing process intermediates, and evaluating how effectively manufacturing processes remove and inactivate viruses. Viral clearance studies verify virus removal or inactivation by a manufacturing process. Although regulatory agencies have expectations for the designs of those…

Modern Technology Transfer Strategies for Biopharmaceutical Companies

Application of industrial biotechnology has changed dramatically over the past decade. Stainless steel process equipment has largely given way to disposable systems, facilitating easier and quicker process configurations and up-scaling. Suppliers generally made incremental advances in the quality of raw materials and consumables to ensure that those could more readily comply, “off the shelf,” with regulatory expectations. Once out-of-reach analytical equipment such as mass spectrometers and cell analyzers are becoming more common place in development laboratories, which better enables biopharmaceutical…

A Quick Guide for Sourcing Biopharmaceutical Raw Materials

Before the ratification of regulatory guidelines from The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8–Q11 (1–4) — whose scope includes raw materials for biopharmaceutical production — many drug manufacturers chose the most cost-effective and readily available raw materials sourcing options without specifically considering the provenance of those materials. Depending on the chosen supply chain, such materials could be of widely varying quality and not necessarily suitable for a destined application. Raw-material…

The Single-Use Watering Hole: Where Innovation Needs Harmonization, Collaboration, and Standardization

Within the past few years, the single-use technology (SUT) arena of the biopharmaceutical industry has exploded in growth. Leading organizations have predictably and understandably stampeded to the “watering hole” of single-use to drink up the advantages that disposable components offer over traditional multiuse parts and technologies. The initial value and risk-reduction results are being realized — but not without the emergence of other trade-offs. End users continue to call for standardization in emerging areas of the industry while also recognizing…