Manufacturing

Special Report: Toward Sustainable Engineering Practices in Biologics Manufacturing

Introduction by William P. Flanagan Biopharmaceutical development and manufacturing demand scalable processes that can be quickly developed, easily implemented, and smoothly transferred to production. Disposable, ready-to-use technologies play a crucial role in providing flexibility to support agile biomanufacturing operations. Single-use systems provide process efficiencies by removing steps such as cleaning and cleaning validation, thus allowing for faster change-over between manufacturing runs. The biopharmaceutical industry is increasingly adopting single-use approaches, and the global market for such bioprocessing tools is expected to…

Advances in Bioprocessing: Single-Use and Stainless Steel Technologies

The increasing penetration of disposable devices in the biopharmaceutical manufacturing industry has been well documented, and with good reason. These applications represent a new paradigm in the evolution of biomanufacturing technologies and practices, opening the industry up to new possibilities such as flexible and modular facilities. But stainless steel applications and innovations remain vital to this industry. Some stainless devices may be irreplaceable, including large tanks, autoclavable and heat-sterilized fermentors and bioreactors, and storage and filling devices. Other innovations in…

The Single-Use or Stainless Steel Decision Process: A CDMO Perspective

Decisions regarding whether and when to use single-use (SU) (disposable) devices or stainless steel (SS) equipment for biopharmaceutical manufacturing have been discussed for more than a decade. To date, no argument in terms of safety, cost-effectiveness, or operational efficiency is fully convincing to choose one technology platform or the other for all applications. Biopharmaceutical companies often do not have in-use data to make strategic manufacturing decisions. But one group has been significantly growing its expertise in use of single-use technologies:…

Meeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering Challenge

Classical stainless steel installations in purpose-built facilities dominate the global capacity for commercial biopharmaceutical manufacturing. Early facilities that were designed for single-product processes are now aging, putting them on the investment radar for upgrades to enable manufacturing diversity, and allow more efficient facility use. More than ever before, global engineering leaders are confronted with complex strategic and financial decisions when they seek to invest capital in new flexible pharmaceutical facilities or flex-grading aging facilities for supply of pipeline products. Manufacturing…

End-User Considerations: How Biopharmaceutical Companies and Their Employees Approach Single-Use and Stainless Steel

Along with the other perspectives offered in this special issue, people tasked with actually implementing and working with single-use, stainless-steel, or the more common variations of hybrid systems deserve a say also. When seeking out end-user comments, however, we should consider both the overall company decisions about which systems to use (decisions that may not have accommodated much input from the manufacturing floor) and opinions from individual scientists, technicians, and process engineers themselves who are presented with the facility design and…

Choosing Between Single-Use and Multiuse Technologies: An Interphex 2015 Roundtable Discussion

On Tuesday, 21 April 2015, Eric S. Langer (managing partner at BioPlan Associates) chaired a midday roundtable titled, “Deciding on Single-Use vs. Stainless Steel Bioprocessing Strategy: What Do CMOs Know That Biopharmas Don’t?” Langer brought together several industry experts to discuss choosing between stainless steel and single-use technologies (SUTs) for different applications: William Hartzel (director of strategic execution at Catalent Pharma Solutions) Steven Perry (vice president of technical operations at Cook Pharmica) Joanna Pezzini (bioprocess engineer at MedImmune) Daniel Vellom…

Single-Use and Stainless Steel Technologies: Comparison, Contrast — Where Are They Going?

At a recent conference, there was much talk about a major biopharmaceutical project in Asia for which the owner of a company chose a design with primarily traditional multiuse stainless steel tanks and processing equipment, rather than single-use polymer equipment. There were even some stainless steel equipment vendors toasting at the bar that this may be the beginning of a “renaissance” of stainless steel. Is the single-use systems (SUS) honeymoon over? Are many industry professionals hoping this is the end…

Single-Use Biopharma Product Recycling: An Alternative Process to Unlock the Challenges

This webcast features: Jacqueline Hollands Ignacio, Corporate Responsibility Programs Manager – Customer Initiatives, MilliporeSigma, and Michael Farrell is Corporate Disposal Coordinator, Triumvirate Environmental. As the biopharmaceutical industry increases the adoption of single-use manufacturing products, the issue of recycling becomes a challenge. Disposal and recycling the plastics from these products is a challenging task due to many factors such as limitations within the recycling infrastructure, products containing a mix of materials and plastics, and biopharmaceutical products can contain biologically hazardous materials…

Standardization of Disposables Design: The Path Forward for a Potential Game Changer

Recent articles have described how the debate on standardization is slowing down adoption of single-use technology (1). The Standardized Disposables Design (SDD) initiative is working to design simple standard single-use solutions for real-life examples (e.g., buffer bags). In reality, a buffer is a buffer whether it is made in Europe, Asia, or America, so in essence different solutions are not necessary for different end users. A buffer bag is not difficult to design, and it does not vary greatly in…

Outsourcing Stability Testing: Discussions with Contract Laboratories

Stability testing is required for all biopharmaceutical drug products to detect all changes in identity, purity, and potency as a result of a number of environmental and processing factors. Whether testing is conducted in-house or through contact laboratories, it involves the development and performance of comprehensive and specific stability protocols for all stages of a product’s life cycle (1). Testing product stability in-house requires signficant time and resources, and carries challenges associated with commercialization market, time, and capacity. Market: The…