Bioprocess Intensification: Technologies and Goals

Whitford, William G.

doi:10.1002/9783527827343.ch4

Cited by 3 publications

(2 citation statements)

References 36 publications

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“…In addition, Level 2 intensification may require the need for automation software enabling unit orchestration, depending on which unit operations are connected. This could be considered a limiting factor at this level, given that there are other ways to intensify the process to Level 2 without introducing the complexity of automation orchestration (Whitford, 2022). However, within Level 2 intensification, users have the choice to either use various, nearly unlimited unit operations connected by a software orchestration layer or move towards orchestration of unit operations on a system level, with reduced options of available systems and unit operations.…”

Section: Choosing a Process Intensification Scheme For A Processmentioning

confidence: 99%

Reviewing the process intensification landscape through the introduction of a novel, multitiered classification for downstream processing

Crowley,

Cashen,

Noverraz

et al. 2024

Biotech & Bioengineering

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A demand for process intensification in biomanufacturing has increased over the past decade due to the ever‐expanding market for biopharmaceuticals. This is largely driven by factors such as a surge in biosimilars as patents expire, an aging population, and a rise in chronic diseases. With these market demands, pressure upon biomanufacturers to produce quality products with rapid turnaround escalates proportionally. Process intensification in biomanufacturing has been well received and accepted across industry based on the demonstration of its benefits of improved productivity and efficiency, while also reducing the cost of goods. However, while these benefits have been shown empirically, the challenges of adopting process intensification into industry remain, from smaller independent start‐up to big pharma. Traditionally, moving from batch to a process intensification scheme has been viewed as an “all or nothing” approach involving continuous bioprocessing, in which the factors of complexity and significant capital costs hinder its adoption. In addition, the literature is crowded with a variety of terms used to describe process intensification (continuous, periodic counter‐current, connected, intensified, steady‐state, etc.). Often, these terms are used inappropriately or as synonyms, which generates confusion in the field. Through a detailed review of current state‐of‐the‐art systems, consumables, and process intensification case studies, we herein propose a defined approach in the implementation of downstream process intensification through a standardized nomenclature and viewing it as distinct independent levels. These can function separately as intensified single‐unit operations or be built upon by integration with other process steps allowing for simple, incremental, cost‐effective implementation of process intensification in the manufacturing of biopharmaceuticals.

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Section: Choosing a Process Intensification Scheme For A Processmentioning

confidence: 99%

Reviewing the process intensification landscape through the introduction of a novel, multitiered classification for downstream processing

Crowley,

Cashen,

Noverraz

et al. 2024

Biotech & Bioengineering

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show abstract

“…With the difference in the specific regulatory requirements across different global regions of interest due to their high pharmaceutical production capacity, there is a need for technologies that can adapt to the proprietary processes of various pharmaceutical entities while still adhering to the stipulated regulations. Furthermore, there is recent interest in the field of bioprocess intensification in the context of continuous production [50]. Hence, in order to develop, analyze, and control a continuous pharmaceutical manufacturing process, it is necessary to put new developments in the field of process analytical technology (PAT), specifically bioprocess monitoring, into practice [51].…”

Section: Challenges and Trends In Meeting Regulatory Requirementsmentioning

confidence: 99%

Methods and Analysis of Biological Contaminants in the Biomanufacturing Industry

et al. 2023

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The advent of bioprocessing has revolutionized the biomanufacturing industry, leading to the rise of biotherapeutics derived from biologic products such as chimeric antigen receptor (CAR) T-cells used for targeted cancer treatment and the Vero cell line for the production of viral vectors and vaccines. Despite these promising developments, most biologic products are characterized by fragile macromolecular structures that are heterogenous with a purity profile that varies with each batch making them susceptible to microorganism contamination. Regulatory oversight of biologic products is imperative to ensure adherence to good manufacturing practices and compliance with quality management systems. Current quality assurance protocols during production include monoclonality during cell line development, real-time monitoring of process parameters, flow cytometry for microbial monitoring, polymerase chain reaction, and immunoassay techniques to amplify DNA sequences related to bacterial or biological contaminants. FDA guidance recommends the implementation of process analytical technology within biomanufacturing production to measure critical quality parameters, which includes screening for potential biological contamination. Future advancements in bioprocess monitoring and control should capitalize on providing cheap, real-time, and sensitive detection. Biosensors, mass spectrometry, and polymerase chain reaction present robust, rapid, and real-time capabilities for multiplexed detection of contaminant analytes and have shown promise in meeting these needs. This review discusses the main biological contaminants of bioprocesses, European Union and FDA regulatory guidelines for monitoring and control within biologics production, existing methods and their limitations, and future advancements for biological contamination detection.

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Intensification of bioprocesses – definition, examples, challenges and future directions

Hartmann,

Krieg,

Holtmann

2024

Physical Sciences Reviews

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Strategies to reduce cost and emission profiles are becoming increasingly important for the development of affordable and sustainable bio-based production. The overall objective of process intensification in different industries is to achieve substantial benefits in terms of cost, product concentration and quality, while eliminating waste and improving process safety. Intensification of bioprocesses could be a valuable tool for enhancing the efficiency and reducing resource consumption in bioproduction. In general, bioprocess intensification is defined as an increase in bioproduct output relative to cell concentration, time, reactor volume or cost. This brief overview provides a definition of process intensification in biotechnology, presents several general and specific examples, and addresses some of the current challenges.

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Bioprocess Intensification: Technologies and Goals

Cited by 3 publications

References 36 publications

Reviewing the process intensification landscape through the introduction of a novel, multitiered classification for downstream processing

Reviewing the process intensification landscape through the introduction of a novel, multitiered classification for downstream processing

Methods and Analysis of Biological Contaminants in the Biomanufacturing Industry

Intensification of bioprocesses – definition, examples, challenges and future directions

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