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Use of Enzymes in the Downstream Processing of Biopharmaceuticals
Published in Peter Grunwald, Pharmaceutical Biocatalysis, 2019
The manufacturing of biopharmaceuticals encompasses a string of activities that are designed with the goal of producing a certain mass or biological activity of a target product with specific quality attributes. These activities can be grouped into two stages: the upstream processing, which comprises the generation of cell lines/strains, the establishment of cell banks, inoculum preparation and cell cultivation, and the downstream processing, which includes all the unit operations required to purify the product up to a point where pre-defined, end-product specifications are met (Heinzle et al., 2006; Jungbauer, 2013).
Overview of Drug Development
Published in Mark Chang, John Balser, Jim Roach, Robin Bliss, Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials, 2019
Mark Chang, John Balser, Jim Roach, Robin Bliss
Biopharmaceuticals are products which are derived using living organisms to produce or modify the structure and/or functioning of plants or animals with a medical or diagnostic use. Biopharmaceuticals are becoming increasingly important because they are more potent and specific, as they are similar to the proteins within the body, and hence are more effective in treating our diseases. There are three major areas in which biopharmaceuticals are used: as prophylactic (preventive, as in the case of vaccines), therapeutic (antibodies) and replacement (hormones, growth factors) therapy. Another term that is used for protein-based drugs is biologics.
Nonclinical Safety Evaluation of Drugs
Published in Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath, Page R. Bouchard, Toxicologic Pathology, 2018
Thomas M. Monticello, Jeanine L. Bussiere
Biopharmaceuticals (or large molecules) are defined as products in which the active substance is produced by, or extracted from, a biologic source. Since the first FDA biologic approval of insulin in 1982, there have been more than 250 additional biopharmaceutical approvals, including recombinant and monoclonal antibody (mAb)-based products and recombinant vaccines (Shankar et al. 2006). Recently, from the period of 2010 to 2016, biopharmaceuticals have represented over 20% of all new and approved drugs (Mullard 2017). Some biopharmaceuticals have had safety-related regulatory actions postapproval, such as a notification letter sent to healthcare professionals, a modification to the drug insert label, or an added “black box” warning to the label (Giezen et al. 2008). Such safety warnings have included general disorders, administration side effects, infections, immune system disorders, and tumor risk.
Harnessing the potential of machine learning for advancing “Quality by Design” in biomanufacturing
Published in mAbs, 2022
Ian Walsh, Matthew Myint, Terry Nguyen-Khuong, Ying Swan Ho, Say Kong Ng, Meiyappan Lakshmanan
Biopharmaceuticals such as monoclonal antibodies (mAbs) and fusion proteins are currently the most lucrative drugs in the market: 7 of the top 10 drugs in 2019 are biopharmaceuticals.1 Unlike small molecules, biopharmaceuticals are large, complex drugs that are typically produced using live mammalian cells.2 The biological activity of biopharmaceuticals is extremely sensitive to variations in their critical quality attributes (CQAs), such as the N-glycosylation, charge distribution and aggregation.3–6 The biopharmaceutical product quality is also extremely sensitive to changes in the underlying biomanufacturing operating conditions and raw materials. Even a minor variation in bioreactor physicochemical conditions such as pH, temperature, dissolved oxygen (dO2) and cell culture media can lead to significant alterations in different product quality attributes. For example, cell culture pH has been shown to greatly affect multiple quality attributes of the mAbs, including N-glycosylation,7–10 aggregation,10,11 and charge variations.10,12 Therefore, biomanufacturing is highly regulated to ensure the safety and efficacy of biologic products.
Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance
Published in Expert Review of Clinical Pharmacology, 2022
Hasumati Rahalkar, Alan Sheppard, Sam Salek
The success of biosimilars in the market will depend on the strategic choices’ that biopharmaceutical firms make. It is hoped that the improved regulatory model resulted from this study and presented here might serve as a basis for strategizing and planning for an efficient, transparent and harmonized or standardized biosimilar development and approval process among the emerging economies. While there are challenges ahead, biosimilars present unique opportunities to bring innovative medicines with an affordable price to patients and enhance the biopharmaceutical industry’s performance. It is hoped that biosimilars, along with originator biologics, will be an important part of the healthcare systems in the emerging economies [5]. A joint effort by all the stakeholders can ensure faster delivery of medicines to patients across the globe.
Microneedles for drug delivery: recent advances in materials and geometry for preclinical and clinical studies
Published in Expert Opinion on Drug Delivery, 2021
Nae-Won Kang, Sungho Kim, Jae-Young Lee, Ki-Taek Kim, Yuji Choi, Yujeong Oh, Jongchan Kim, Dae-Duk Kim, Jung-Hwan Park
Even though there have been many preclinical studies about four types of microneedles (i.e. coated, dissolving, separable, and swellable), only a few clinical studies have been implemented on them (Table 3). The causes of the imbalance between preclinical and clinical studies seem to be considered as follows: (1) Application of MAP should have the advantages over the current route of drug administration. For example, in preclinical studies, some MAPs loaded the drugs that were currently administered in oral formulation, such as alendronate, metformin, ibuprofen, and donepezil chloride. Even though these MAPs provided a relatively greater drug delivery efficiency, their advantages need to be much more than the oral dosage form. But, current studies do not seem to. (2) Currently, there have been many preclinical studies about stimuli-responsive and specially designed MAPs. The fabrication methods for these MAPs usually required the complicated synthesis of functional polymers and fabrication steps, thereby hampering the feasibility of conducting clinical trials. (3) The safety issue of certain drugs, such as anti-cancer agents and biopharmaceutics, which can cause a severe side effect depending on dose need to be guaranteed. The initial high concentration and slow distribution of the drugs throughout the body can be more toxic to the administered site than other types of drugs.