Process characterization strategy for a precipitation step for host cell protein reduction

Prentice, Jessica; Vu, Diemchi; Robbins, David J.; Ferreira, Gisela

doi:10.1002/btpr.2908

Cited by 3 publications

(1 citation statement)

References 21 publications

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“…Building a robust process with an eye toward improved productivity, manufacturability, use of raw materials and leveraging an efficient platform approach is the gateway to improved cost of goods. To that end, early investment in a Quality by Design approach to optimize productivity with a clear eye on the impurity profile is a huge positive benefit (Auclair & Rathore, 2021;Prentice et al, 2020;Rathore, 2009Rathore, , 2010Rathore & Devine, 2008;Rathore et al, 2018). Also important is investing in a platform process that utilizes a common serotype (as would be the case for adeno-associated virus [AAV]) such that all aspects of upstream and downstream manufacturing are similar with only minor tweaks for the specific construct or transgene in question.…”

Section: Patient Accessmentioning

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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