Although the public-health emergencies associated with the COVID-19 pandemic are abating, biomanufacturers continue to apply many of the production and business-development strategies that they have devised since 2020. Flexibility remains paramount. To that end, companies are seeking out biomanufacturing facility designs that enable nimble, cost-effective production campaigns, often in multiproduct and/or multimodality environments. Read this month’s featured report to learn about manufacturing and operational strategies that are gaining traction in the post-COVID biopharmaceutical industry. First, a writer from the Bioprocess to Product (BP2P) Network highlights the need for organizations that connect developers of all manner of bioproducts with available manufacturing capacity in the United States. Next, writers from Arcadis DPS Group explore the advantages and new challenges associated with incorporating both multiuse and single-use bioprocess equipment in the same biofacility. Citing a recent survey of life-science professionals, writers from CRB describe the industry’s slow-but-growing interest in integrated project delivery for large capital expenditures such as facility build-out. Finally, a regulatory consultant from PharmaLex reflects on the lasting impact of virtual facility audit processes that began during the pandemic.
Addressing Gaps in US Biomanufacturing Capacity
by Matt Gardner (board chair of the scientific advisory group at BioP2P Network, founder of the California Biomanufacturing Center)
In 2021, the United States government issued significant funding to revitalize domestic biomanufacturing. Specifically, the government seeks to address a lack in flexible and scalable production capabilities that would help the nation to thrive in the global bioeconomy. To accelerate biomanufacturing research and development, nonprofit organization California Biomanufacturing Center (CBC) spearheaded the 2022 development of the Bioprocess to Product (BioP2P) Network. The initiative seeks to unite biomanufacturers and technology developers to provide test beds for innovations in scalable bioprocess equipment, particularly for processes involving fermentation. In this article, CBC’s founder describes the network’s plans and how the project could accelerate biomanufacturing transformation in the United States.
Hybrid Design Considerations in Biomanufacturing: Leveraging Both Stainless-Steel and Single-Use Systems
by William Whitford and Paul Szafir
From preclinical through commercial biopharmaceutical manufacturing, the vast majority of production campaigns now incorporate single-use (SU) equipment at some stage of the process. SU formats continue to proliferate for bioreactors, filters, fluid-transfer systems, and many other biomanufacturing supplies. Meanwhile, industry vendors continue to design SU systems specifically for emerging modalities. However, many biopharmaceutical manufacturers are leveraging “hybrid” setups with both single- and multi-use formats in their facilities. In this article, writers from a facility design and engineering firm explore contexts in which hybrid-equipment facilities could surmount limitations associated with applying only SU or stainless-steel formats. The writers also anticipate difficulties for hybrid setups, including new challenges for quality assurance and equipment procurement and maintenance.
Change Is Difficult, But It Is Inevitable: The Value of Integrated Project Delivery to Biomanufacturing-Facility Construction
by Mike Barrett and Carl Rohs
The COVID-19 pandemic changed biomanufacturing-facility construction in ways that underscored the value of integrated project delivery (IPD), a holistic approach to completion of large capital projects. Although the approach can raise benefits for all facility-build stakeholders, and in spite of important shortcomings with traditional design–build (DB) and design–bid–build (DBB) models, the biopharmaceutical industry is making only halting moves toward wide IPD adoption. In this article, writers from CRB highlight key insights from the company’s recent Horizons: Life Sciences survey to investigate why industry decision-makers still favor such project-delivery methods over IPD. Barrett and Rohs also identify IPD concepts with which survey respondents seemed most familiar and explore how further IPD adoption could expedite and improve biomanufacturing-facility design and construction.
The Future of Virtual Audits and Audit Success
by Kate Coleman
At the height of the COVID-19 public-health emergency, virtual audits enabled biopharmaceutical companies to maintain regulatory compliance and perform quality assurance (QA) activities despite difficulties introduced by travel restrictions, social-distancing requirements, and limits to facility access. Because the pandemic has subsided in many parts of the world, onsite facility inspections have resumed. However, as Kate Coleman explains, virtual audits will continue to be an indispensable tool throughout the industry. Coleman describes what benefits can be leveraged by performing remote inspections, then highlights key considerations for developing a sound virtual-audit strategy that accounts for potential problems with technology, access, and cybersecurity.