Single Use

Simplifying the Route to GMP with a
Risk-Based Approach to Single-Use Implementation

Adopting single-use systems (SUS) is an attractive solution for current challenges within the biopharmaceutical industry. However, before implementing single-use solutions, biomanufacturers must ensure that the required SUS product quality attributes are met. In this special report, subject-matter experts from Sartorius provide insights into SUS implementation strategies for biopharmaceutical manufacturing. Their discussion covers four pillars: forming a regulatory strategy, addressing flexible radiation-sterilization processes, assessing extractables and leachables (E&L), and assuring system integrity and robustness. Then, the writers present a case study…

Single-Use Systems: Providing Biopharmaceutical Manufacturers with Cutting-Edge Material and Assembly Solutions

Recent years have witnessed biopharmaceutical manufacturers transition swiftly from traditional stainless-steel systems that require harsh sterilization between applications to single-use systems (SUS) that are less expensive, faster to produce, and — perhaps counterintuitively — more compatible with sustainability initiatives (1). Now that disposable systems have become industry standard, biopharmaceutical original equipment manufacturers (OEMs) are seeking full-service components partners that can offer further innovations in SUS. Integrated Solutions Some suppliers can provide biopharmaceutical OEMs with tailored assembly solutions in addition to…

Driving Environmental Sustainability in the Biopharmaceutical Industry

In order to enhance access to life-saving medicines, the biopharmaceutical industry must prioritize more efficient therapeutic production. However, the environmental impact of manufacturing choices is facing increasing scrutiny. Sustainability opportunities within the biopharmaceutical sector encompass reducing the environmental footprint, addressing resource depletion, and effectively managing waste through repurposing and recycling. During a recent panel discussion, sustainability experts from Sartorius and their collaborators shared valuable insights on enhancing the sustainability of manufacturing processes. These insights encompass adopting single-use technologies, improving process…

Measurement of Particulates in Single-Use Systems for Cell and Gene Therapies Manufacturing — Part 1: Misapplication of USP <788>

Particulates are mobile, undissolved particles other than gas bubbles that are unintentionally present in an injectable drug product. Patient safety can be compromised by the amounts and types of particulates present in a drug product (1). They differ in nature (e.g., metal, glass, dust, fiber, rubber, polymer, mold, and degradant precipitates) and can be divided into three categories: intrinsic, inherent, and extrinsic particulates. Intrinsic (native) particles are derived from operation of a manufacturing process or its equipment, a product formulation,…

Designing Single-Use Facilities for Biomanufacturing Expansion

Minimizing a facility footprint while maximizing manufacturing capacity is essential to staying agile, productive, and cost-effective — all of which are key elements to competing in a dynamic business landscape. To achieve such efficiency at commercial scale, bioprocessing facility design should be tailored to each organization’s specific needs. During scale-up, tailor-designed facility planning is critical to streamlined manufacturing of high-quality products. The size and layout of a space can otherwise become a limiting factor for long-term productivity, revenue, profit, and…

Dry To Die: Freezing Can Replace Spray Drying for Bulk Intermediates

Valuable bulk biopharmaceutical intermediates, such as bacterial or yeast cells for microbial fermentation or materials produced during a biomanufacturing process, often are transported to and from different manufacturing sites. During that transfer, maintaining product quality while minimizing degradation in desired properties is of utmost importance. It requires carefully controlled and reliable cold-chain logistics, which in turn rely on the equally carefully controlled process steps of freezing and thawing. Spray drying is a widely used method for preserving microbial cells. However,…

Hybrid Design Considerations in Biomanufacturing: Leveraging Both Stainless-Steel and Single-Use Systems

Demand for biopharmaceuticals is growing rapidly as new products and manufacturing technologies arise. For example, such approaches as immunooncotherapy and oncolytic viral therapy are now entering one of the fastest growing markets in medicine — cancer treatment. This market “should grow from [US]$177.4 billion in 2021 to $313.7 billion by 2026, at a compound annual growth rate (CAGR) of 12.1%” (1). Both preclinical and final biomanufacturing increasingly incorporate single-use (SU) components, including hardware and systems for containment and connectivity. Solutions…

Save Valuable Facility Time with Single-Use TFF

Biopharmaceutical developers and manufacturers are part of a global, dynamic, and highly competitive market. They face constant pressure to produce high-quality products within relatively short time frames and at reduced costs. Process-intensification strategies and single-use (SU) solutions are popular approaches to maximizing productivity and promoting fast, efficient, and lean processing — the pillars of next-generation facilities. Filtration is an integral part of all bioprocesses and is applied to many up- and downstream steps, including harvest, clarification, and concentration/diafiltration. Tangential-flow filtration…

Container Materials for Biopharmaceuticals: A Comparative Small-Scale Case Study of Stainless Steel and a Proprietary Nickel-Based Alloy

Evaluating compatibility of a drug substance with all surfaces that it might come into contact with during drug product manufacturing is essential to ensure product quality. Proteins can adsorb to contact surfaces, form aggregates, and desorb into a drug-substance solution. Proteins also can degrade in presence of leachables generated from contact surfaces during manufacturing. Containers and vessels used during manufacturing are single-use disposable components or metal tanks, primarily either 316L stainless steel (SS) or C-276 Hastelloy nickel-based alloy (HLY). Researchers…

Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications

Due to their numerous benefits, single-use systems (SUS) have been increasingly implemented in biopharmaceutical processes in the past decades. Originally used in applications for the preparation and storage of buffer and media, SUS have become more and more important in the commercial production of biopharmaceuticals. Today, biopharmaceutical manufacturers use this technology in critical drug substance or drug product process steps such as formulation, bulk storage, bulk transport, and final filling of drug product. By using single-use technologies, manufacturers can reduce…