Single Use

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production – Part 2: Regulatory Overview

The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Corporate members include plasticequipment suppliers, service providers, and users in the biopharmaceutical industry who share this mission. A key focus of BPSA’s core activities is to educate its members and others through sharing of information and development of best practice guides that help suppliers, users, and…

Integrity Redefined: Consistent Robustness and Integrity Testing Lead to Enhanced Process Integrity and Patient Safety

With the increasing adoption of single-use systems (SUS) in critical stages of biopharmaceutical manufacturing, any lack of system integrity can significantly affect drug product quality and patient safety, as well as incur additional costs due to product loss and disrupted production cycle. This article from Sartorius Stedim Biotech, describes how determining the correlation between liquid leakage and microbial ingress can be used to define MALLs (Maximum Allowable Leakage Limits) of SUS for different process steps. The article also details the…

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production: Part 1: Introduction and Manufacturing Process

by Bio-Process Systems Alliance Cell and Gene Therapy Committee The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Corporate members include plastic-equipment suppliers, service providers, and users in the biopharmaceutical industry who share this mission. A key focus of BPSA’s core activities is to educate its members and others through sharing of information and development…

Scientific and Technological Advancements in Applications of Single-Use Technology: A Conference Report

Single-use technology (SUT) has been used increasingly both in clinical and commercial biomanufacturing (1). Proven major advantages include relatively low capital investment, elimination of batch-to-batch cross contamination and reuse cleaning validation efforts, flexibility in manufacturing, and shortened product lifecycles. However, some challenges and barriers to implementation remain: Consumables costs are increasing. Specific regulatory guidance is lacking, as is component interchangeability and standardization. And few if any leak-proof components/systems are available. International groups and associations focused on setting best practices and…

Visible Particulate Matter in Single-Use Bags: From Measurement to Prevention

Parenteral pharmaceuticals must be “essentially free” from visible particulate matter (1). In the production of biopharmaceuticals with single-use systems (SUS), biocompatibility requires controlling interactions between drug substances/products and SUS surfaces to ensure drug product quality and patient safety with regard to extractables/leachables and particulate matter. Any particulate matter stuck to fluid-contacting surfaces of process components could wash off and contaminate process fluids. Depending on system configuration, a final drug product could be at risk for particulate matter from SUS. Risk…

Recommended Practices for Assuring Integrity of Single-Use Systems

The increasing uptake of single-use technologies (SUTs) in critical current good manufacturing practice (CGMP) processes and applications has made their integrity a critical quality attribute (CQA) for both suppliers and end users of such systems. Current regulations focus on final packaging, however, without taking into account the unique aspects of assemblies used in bioproduction. Ongoing initiatives include revision of PDA TR 27 (1) and creation of A STM workstreams (2, 3) to propose good practices for the integrity of single-use…

Smart Modular Package Units for Single-Use Processing: Addressing Cost, Speed, and Flexibility Challenges in Biologics Manufacturing

How to reduce costs, while still increasing speed, and flexibility in biologics manufacturing currently represent major issues for the biopharma industry. In this article, Burkhard Joksch, Product Manager Bioprocess Automation and Stuart Tindal, Product Manager FlexAct® Platform at Sartorius Stedim Biotech GmbH, detail the evolution of automation for single-use technology towards modular packaging units. They also including case studies of how these units can be used in real life cGMP processes, as well as explain the manufacturing and industry benefits…

Development of Large-Scale Bulk Freezing Systems

The biopharmaceutical industry is under pressure to generate value for shareholders and find innovative therapies while driving down development and manufacturing costs. As the industry considers more flexible and scalable production solutions for patients, new therapies will continue to be developed faster than ever before. These products will need to rely on robust and reliable manufacturing solutions. To deliver on that challenge, streamlining manufacturing processes will be necessary so that many lots of drug substances can be manufactured, stored, and/or…

The Changing Landscape of Single Use in Bioprocessing: An Interview with Stefan Schlack and Jean-Marc Cappia

Single use in bioprocessing has changed significantly in recent years. To find out how a leading supplier to the biopharmaceutical industry is redefining its technology to align with new market challenges, science writer, Sue Pearson, had the opportunity to interview Stefan Schlack, Head of Bioprocess Marketing, and Jean-Marc Cappia, Head of Segment Marketing Vaccines, both at Sartorius Stedim Biotech (SSB) in Goettingen, Germany. Redefining Single Use Pearson: Sartorius Stedim Biotech is a recognized leader in single-use technology, and you’ve recently…

Development and Biomanufacturing Strategies for Next-Generation Antibody-Drug Conjugates

The development and manufacture of antibody-drug conjugates (ADCs) requires a series of complex steps. ADC manufacturers must comply with guidelines for both the small-molecule linker-drug and the monoclonal antibody (MAb). The authors describe their company’s development of its lead ADC product. They review process decisions, including the issues that factored into their selection of single-use systems, manufacturing challenges (differences between ADCs and MAbs), and testing methodologies for extractables and leachables. Synthon began as a small-molecule generics company in 1991. During…