Single Use

Single-Use Technologies: BIO Theater @ Interphex 2015

Andrew Lidums (NA business development manager, Parker domnick hunter) 2:30–2:55 pm Implementing a Risk-Management–Based Approach to the Prevention of Mycoplasma Contaminations Lidums began with a recent report from Genentech, where a 150-µm long Leptospira organism from a drainage ditch outside the facility managed to penetrate 0.1-µm filters. The company solved this problem by lowering the temperature of the filtration operation, which made the bacteria more rigid and kept them from getting through. Clearly, however, contaminations happen even at large facilities.…

Toward Industry Standardization of Extractables Testing for Single-Use Systems: A Collective BPSA Perspective

Here we present a consensus position of the membership of the Bio-Process Systems Alliance (BPSA), the trade organization for the single-use industry based in Washington, DC. BPSA’s membership includes 48 corporate and institutional entities, among them component suppliers, systems integrators, end users, and independent testing laboratories. Consensus within this membership is reached through an official ballot of representative voting members, as provided for in the organization’s by-laws. The position outlined below was approved by such an internal consensus-balloting process. Building…

Extractables Profiles: A Comprehensive Approach Produces Long-Term Results

Biopharmaceutical manufacturers spend years developing and testing new drug and biologic products to ensure their efficacy, safety, and usability for patients. Such knowledge is extremely valuable, but those same principles often get overlooked in selection of packaging and delivery systems. Decisions on packaging and delivery often are made almost as an afterthought. However, issues related to components such as extractables and leachables can affect patient safety and product quality. In addition, a lack of extractables and leachables data in filings…

The New Hybrid: Single-Use Systems Enabled By Process Automation

Much has been written in recent years about the union of single-use systems (SUS) and process automation. These two technology initiatives have been prevalent within biopharmaceutical manufacturing over the past decade and are two of the most predominant advancements in biomanufacturing. A basic survey of industry media and conference topics corroborates that premise (1). However, efforts to combine them remain in the early stages of technological fulfillment, with much work to be done in realizing their synergistic benefits. Here I…

Automation of a Single-Use Final Bulk Filtration Step: Enhancing Operational Flexibility and Facilitating Compliant, Right–First-Time Manufacturing

Single-use technologies have been implemented in biomanufacturing facilities all over the world. Inherently more flexible than stainless steel equipment, single-use technology allows for more rapid technology transfer by minimizing the time it takes to design, purchase, and qualify new capital assets. Rapid turnover between batches is facilitated with no need for protracted clean-in-place (CIP) and steam-in-place (SIP) regimes; the risk of product cross contaminations is reduced because single-use fluid-contact surfaces are never previously exposed to a biopharmaceutical product stream. For…

Measuring Pressure at Very Low Levels with High Accuracy in Single-Use Systems: Improved Performance and Single-Use System Testing

Measuring pressure in single-use systems (SUS) has become an integral part of both upstream and downstream bioprocess operations. Articles have been published on filtration applications (1), and integration into other SUS has been widely adopted. Additionally, information is available on low-pressure applications such as how to prevent overpressurization in single-use bioreactors (2). However, as users and applications both become more sophisticated, improved performance is sought for low-pressure applications (<1 psi) such as in single-use bioreactors. The reasons are two-fold: First,…

Implementing Flexible, Scalable, and Cost-Efficient Bioprocess Platforms: A Proven Project Management Approach

Although significant scientific progress has been made in the biotechnology industry, it has lagged behind other sectors — such as aviation and automotive — in developing, scaling up, and industrializing products coming out of R&D. The goal is to implement robust and reliable manufacturing processes for good manufacturing practice (GMP) market supply cost-effectively. But manufacturing methods for biologics have remained unchanged for decades, with large-scale, capital-intensive stainless steel facilities taking three to five years to build and remaining both energy…

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…

Exploring Options for Dual Sourcing of Single-Use Components

As the bioprocess industry progressively adopts single-use technologies for large-scale manufacturing (1, 2), biomanufacturers’ increased reliance on integrators for critical production equipment continues to raise concerns about supply chain security. The need to mitigate risks associated with the supply of single-use components (e.g., bioreactors, aseptic connectors, tubing, filters) has led to growing interest in the dual sourcing of those materials. To that end, integrators and end users alike are exploring the definition of functionally equivalent products, how functional equivalency can…

Sterilization Effects on Elastomer Characteristics and Functionality in Parenteral Delivery Systems

To drive efficiencies in producing parenteral drug products, manufacturers are using containers and closure components that are received sterile and ready to be introduced into filling lines. The effects of sterilization on the properties of ready-to-use (RU) components must be assessed to ensure proper processing techniques and suitability over the components’ intended shelf lives. Sterile-drug manufacturers must determine the best sterilization method for components based on their respective drug products and processes. Critical areas of risk include potential changes related…