Large-scale manufacture of monoclonal antibodies for use in humans

1990 ◽  
Vol 18 (2) ◽  
pp. 245-247 ◽  
Author(s):  
C. R. HILL
2021 ◽  
Vol 14 (7) ◽  
pp. 700
Author(s):  
Theodoros Mavridis ◽  
Christina I. Deligianni ◽  
Georgios Karagiorgis ◽  
Ariadne Daponte ◽  
Marianthi Breza ◽  
...  

Now more than ever is the time of monoclonal antibody use in neurology. In headaches, disease-specific and mechanism-based treatments existed only for symptomatic management of migraines (i.e., triptans), while the standard prophylactic anti-migraine treatments consist of non-specific and repurposed drugs that share limited safety profiles and high risk for interactions with other medications, resulting in rundown adherence rates. Recent advances in headache science have increased our understanding of the role of calcitonin gene relate peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide (PACAP) pathways in cephalic pain neurotransmission and peripheral or central sensitization, leading to the development of monoclonal antibodies (mAbs) or small molecules targeting these neuropeptides or their receptors. Large scale randomized clinical trials confirmed that inhibition of the CGRP system attenuates migraine, while the PACAP mediated nociception is still under scientific and clinical investigation. In this review, we provide the latest clinical evidence for the use of anti-CGRP in migraine prevention with emphasis on efficacy and safety outcomes from Phase III and real-world studies.


2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Matthew T. Bryan ◽  
Elizabeth L. Martin ◽  
Aleksandra Pac ◽  
Andrew D. Gilbert ◽  
Feodor Y. Ogrin

AbstractBiological cilia generate fluid movement within viscosity-dominated environments using beating motions that break time-reversal symmetry. This creates a metachronal wave, which enhances flow efficiency. Artificially mimicking this behaviour could improve microfluidic point-of-care devices, since viscosity-dominated fluid dynamics impede fluid flow and mixing of reagents, limiting potential for multiplexing diagnostic tests. However, current biomimicry schemes require either variation in the hydrodynamic response across a cilia array or a complex magnetic anisotropy configuration to synchronise the actuation sequence with the driving field. Here, we show that simple modifications to the structural design introduce phase differences between individual actuators, leading to the spontaneous formation of metachronal waves. This generates flow speeds of up to 16 μm/s as far as 675 μm above the actuator plane. By introducing metachronal waves through lithographic structuring, large scale manufacture becomes feasible. Additionally, by demonstrating that metachronal waves emerge from non-uniformity in internal structural mechanics, we offer fresh insight into the mechanics of cilia coordination.


Author(s):  
Natalia Glumińska ◽  
Magdalena Krzesłowska

Monoclonal antibodies (mAbs) are widely used in medical therapy and diagnostics, veterinary therapy, and research. The demand for mAbs reaches several dozen tons per year and is constantly growing, approaching the limits of current production possibilities. Mammalian expression systems, which currently dominate the bioproduction industry, have limited production capacity and require high capital investment and production costs. Plants are becoming promising expression platforms due to their scalability, speed, low cost of production, low risk of contamination from animal pathogens and eukaryotic mechanisms of post-translational protein modification. The transgenic plants used for the production of mAbs can be obtained by stable transformation of plant cells as well as transient expression of foreign proteins. In this review, we extract a broad overview of articles, many of them from recent years, concerning modern approaches to producing monoclonal antibodies in plants, methods for modifying the carbohydrate profile of mAbs, and purifying the resulting product. We also present current data on the practical use of mAbs in medical therapies and potential methods of producing antibodies on a very large scale, able to meet the future market demand.


Author(s):  
Johannes F. Buyel ◽  
Richard M. Twyman ◽  
Rainer Fischer

Author(s):  
Ahmad Yaman Abdin ◽  
Prince Yeboah ◽  
Claus Jacob

Chemical synthesis is a science and an art. Rooted in laboratory or large-scale manufacture, it results in certain side products, eventually compromising the integrity of the final products. Such “impurities” occur in small amounts and, within chemistry itself, are of little concern. In pharmacy, in contrast, impurities increase the potential for toxicity, side effects, and serious implications for human health and the environment. The pharmaceutical regulatory agencies have therefore developed regulatory and strategic systems to minimize the chemical presence or biological impact of such substances. Here, pharmaceuticals are turned from impure into more defined materials as part of a complex socio-technological system revolving around and constantly evolving its specific rules and regulations. Whilst modern analytical methods indicate the presence of impurities, the interpretations of corresponding results are gated by risk management and agreed thresholds. Ironically, this allows for entities with no identified chemical structures, and hence epistemologically outside chemistry, to be regulated in pharmaceutical products. We will refer to such substances which are not, epistemologically speaking, “chemicals” as Xpurities, in order to distinguish them from recognized and identified impurities. The presence of such Xpurities is surprisingly common and constitutes a major issue in pharmaceutical research and practice. We propose a Space of Information to deal with such impurities based on values regarding the presence, chemical identities, and biological activities. It is anticipated that this may enable pharmacists to handle such Xpurities more efficiently.


2019 ◽  
Vol 7 (6) ◽  
pp. 1575-1583 ◽  
Author(s):  
Sijie Zhou ◽  
Zeke Liu ◽  
Yongjie Wang ◽  
Kunyuan Lu ◽  
Fan Yang ◽  
...  

Accelerating inorganic nanocrystal-based photovoltaic technology needs more efficient synthetic protocols for large scale manufacture, high yield and excellent quality nanocrystal materials.


PLoS ONE ◽  
2012 ◽  
Vol 7 (6) ◽  
pp. e39419
Author(s):  
Zhao Wang ◽  
Huang Huang ◽  
Hanshuo Zhang ◽  
Changhong Sun ◽  
Yang Hao ◽  
...  

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