Buffer recycling in downstream processing of biologics

Jungbauer, Alois; Walch, Nicole

doi:10.1016/j.coche.2015.06.001

Cited by 13 publications

(5 citation statements)

References 51 publications

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“…It is feared that impurities could be carried along and may accumulate over several production cycles. There are protocols and procedures available on how to handle buffer recycling (Jungbauer & Walch, 2015). Another possibility is to use waste streams for other purposes and a kind of upcycling has been proposed.…”

Section: Sustainabilitymentioning

confidence: 99%

Status and future developments for downstream processing of biological products

Jungbauer,

Ferreira,

Butler

et al. 2024

Biotech & Bioengineering

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Governments and biopharmaceutical organizations aggressively leveraged expeditious communication capabilities, decision models, and global strategies to make a COVID‐19 vaccine happen within a period of 12 months. This was an unusual effort and cannot be transferred to normal times. However, this focus on a single vaccine has also led to other treatments and drug developments being sidelined. Society expects the pharmaceutical industry to provide an uninterrupted supply of medicines. However, it is often overlooked how complex the manufacture of these compounds is and what logistics are required, not to mention the time needed to develop new drugs. The overarching theme, therefore, is patient access and how we can help ensure access and extend it to low‐ and middle‐income countries. Despite unceasing efforts to make medications available to all patient populations, this must never be done at the expense of patient safety. A major fraction of the costs in biopharmaceutical manufacturing are for drug discovery, process development, and clinical studies. Infrastructure costs are very difficult to quantify because they often depend on whether a greenfield facility or an existing, depreciated facility is used or adapted for a new product. To accelerate process development concepts of platform process and prior knowledge are increasingly leveraged. While more traditional protein therapeutics continue to dominate the field, we are also experiencing the exciting emergence and evolution of other therapeutic formats (bispecifics, tetravalent mAbs, antibody‐drug conjugates, enzymes, peptides, etc.) that offer unique treatment options for patients. Protein modalities are still dominant, but new modalities are being developed that can be learned from including advanced therapeutics‐like cell and gene therapies. The industry must develop a model‐based strategy for process development and technologies such as continuous integrated biomanufacturing must be adopted. The overall conclusion is that the pandemic pace was unsustainable, focused on vaccine delivery at the expense of other modalities/disease targets, and had implications for professional and personal life (work‐life balance). Routinely reducing development time from 10 years to 1 year is nearly impossible to achieve. Environmental aspects of sustainable downstream processing are also described.

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Section: Sustainabilitymentioning

confidence: 99%

Status and future developments for downstream processing of biological products

Jungbauer,

Ferreira,

Butler

et al. 2024

Biotech & Bioengineering

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“…The biopharmaceutical industry is making some progress through process intensification, to improve the productivity of integrated upstream and downstream processes (Bisschops & Brower, 2013 ; Brower et al, 2015 ; Jungbauer & Walch, 2015 ), shrink the manufacturing footprint, and reduce energy and water use (Pollard & Pralong, 2017 ). The complexity of achieving carbon‐neutral bioprocessing has been highlighted by initial assessments (Budzinski et al, 2019 ; Pietrzykowski et al, 2013 ).…”

Section: Sustainabilitymentioning

confidence: 99%

“…The complexity of achieving carbon‐neutral bioprocessing has been highlighted by initial assessments (Budzinski et al, 2019 ; Pietrzykowski et al, 2013 ). For example, the first process mass intensity analysis showed bioprocesses to be heavily water intensive, where 90% of the mass was from water (Budzinski et al, 2019 ; Madabhushi et al, 2018 ) and 1 g of biological drug requires up to 65 L of water (Jungbauer & Walch, 2015 ). Lifecycle assessment (LCA) studies have demonstrated that single‐use (SU) technologies provide additional environmental impact advantages over the traditional stainless‐steel manufacturing, such as eliminating clean‐in‐place water usage, reducing HVAC energy usage through the use of closed systems and provide smaller footprint processing (Pietrzykowski et al, 2013 ).…”

Section: Sustainabilitymentioning

confidence: 99%

End‐to‐end collaboration to transform biopharmaceutical development and manufacturing

Erickson¹,

Baker

Barrett

et al. 2021

Biotech & Bioengineering

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An ambitious 10‐year collaborative program is described to invent, design, demonstrate, and support commercialization of integrated biopharmaceutical manufacturing technology intended to transform the industry. Our goal is to enable improved control, robustness, and security of supply, dramatically reduced capital and operating cost, flexibility to supply an extremely diverse and changing portfolio of products in the face of uncertainty and changing demand, and faster product development and supply chain velocity, with sustainable raw materials, components, and energy use. The program is organized into workstreams focused on end‐to‐end control strategy, equipment flexibility, next generation technology, sustainability, and a physical test bed to evaluate and demonstrate the technologies that are developed. The elements of the program are synergistic. For example, process intensification results in cost reduction as well as increased sustainability. Improved robustness leads to less inventory, which improves costs and supply chain velocity. Flexibility allows more products to be consolidated into fewer factories, reduces the need for new facilities, simplifies the acquisition of additional capacity if needed, and reduces changeover time, which improves cost and velocity. The program incorporates both drug substance and drug product manufacturing, but this paper will focus on the drug substance elements of the program.

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“…28 Moreover, enzymatic reactions require the use of biological media, containing nutrients in aqueous buffers, to achieve high activity and selectivity, and the use of the aqueous buffer media gives rise to severe separation and/or distillation steps for downstream processes. 29 These limitations of enzymatic reactions increase the production cost of the final products and can limit the selection of reaction conditions in downstream processes. Accordingly, development of chemical catalysts from sustainable resources that can function through enzymatic mechanisms and are analogous to enzymatic processes 30 is of critical importance for sustainable and economical processes.…”

Section: Introductionmentioning

confidence: 99%