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Herbal Drug Development: Challenges and Opportunities
Published in Megh R. Goyal, Durgesh Nandini Chauhan, Plant- and Marine-Based Phytochemicals for Human Health, 2018
Bhagyashree Kamble, Neelam Athawale, Anand Gugale, Ashika Advankar, Ashwini Ghagare, Shankar Katekhaye, Abhishek Kulkarni, Priyanka Kanukuntla
This technique is useful to identify phytochemicals, which are indistinguishable from adulterant or substituted one. Literature indicates that DNA fingerprint region remains same irrespective of the plant part, whereas chemical content will vary with plant part in use. DNA markers are helpful to identify cells, individuals, species, and so forth, which are responsible to produce normal functioning of proteins to replace defective one. These markers are helpful in treatment of various diseases and helpful to distinguish them.69DNA-based marker helps to distinguish different species such as Taxus wallichiana, Azadirchta indica, Juniperu scommunis, Andrographis paniculata collected from different geographical origin.13Inter simple sequence repeats is polymerase chain reaction-based unique application and inexpensive popular technique of DNA fingerprinting which include DNA tapping, detection of clonal variation, phytogenetic analysis, detection of genomic instability, and assessment of hybridization.69DNA sequencing used for identification of various species due to transverse, insertion, or deletion.92
Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins
Published in mAbs, 2023
Hervé Broly, Jonathan Souquet, Alain Beck
In contrast, FDA’s position on proof of clonality of the population of cells that compose an MCB, which is the starting point of GMP and manufacture of biotechnological products for human use as per ICH Q11, has four key points: (1) a nonclonally-derived cell bank may induce more variability in process performance and cellular phenotype-dependent quality attributes (e.g., glycans), and may result in drift, shift, or unforeseen selective pressure following a process change; (2) the industry view to augment the control strategy is not aligned with the aim of health authorities to promote the quality-by-design concepts; (3) it may be difficult to differentiate non-clonality from other possible root causes in case of a drift identified by the quality system, including the continued process verification; and (4) a non-clonally derived cell bank system may generate variability in product quality due to a lack of consistency in replenishing a working cell bank or during the life cycle of a product.37,55,92,111 Welch & Arden, FDA’s representatives who signed a paper on clonality, concluded “Nevertheless, a demonstration that even clonally derived cell lines possess tremendous heterogeneity (or clonal variation) and that nonclonally derived pools can in some cases produce drug substance with critical quality attributes (CQAs) matching those of drug substance produced by a clonally derived line fails to address key unresolved questions”.55
Local therapy with an engineered oncolytic adenovirus enables antitumor response in non-injected melanoma tumors in mice treated with aPD-1
Published in OncoImmunology, 2022
Dafne C. A. Quixabeira, Victor Cervera-Carrascon, Joao M. Santos, James H.A. Clubb, Tatiana V. Kudling, Saru Basnet, Camilla Heiniö, Susanna Grönberg-Vähä-Koskela, Marjukka Anttila, Riikka Havunen, Anna Kanerva, Akseli Hemminki
Additionally, to evaluate a possible specific anti-tumor response generated towards MC-38 tumors, a mouse IFN-γ ELISpot was performed with splenocytes from re-challenged mice. Interestingly, the mean spots count was statistically significant higher in virus treated group compared to aPD-1 group (p = .004). No significant difference was observed between virus treated group and mock, or virus treated group and naïve animals (Figure 6g). Overall, these results indicate that anti-tumor response following virotherapy is durable and show some extended protection even against clones which have not been previously seen by the immune system. This is potentially relevant in the context of clonal variation which frequently leads to tumor escape from targeted therapies.28
Heterologous recombinant expression of non-originator NISTmAb
Published in mAbs, 2018
Lila Kashi, Katharina Yandrofski, Renae J. Preston, Luke W. Arbogast, John P. Giddens, John P. Marino, John E. Schiel, Zvi Kelman
The United States biotherapeutic monoclonal antibody (mAb) market generates over $100 billion in yearly revenue1. In addition, almost 3,000 candidate biotherapeutics, many of them mAbs, are in some stage of clinical development. Development of biosimilar alternatives is also accelerating because patent protection for many biotherapeutic mAbs expires by 20192. The US Food and Drug Administration (FDA) has approved seven mAb biosimilar alternatives as of December 20173. Therapeutic mAbs are large, complex proteins that contain multiple functional domains, and vary in post-translational modification (PTM). They are often produced in mammalian cells, and differences in growth conditions, such as media composition (i.e., nutrient concentration), media conditions (i.e., pH), and growth time, can affect the yield, structure, PTMs, and function of the expressed mAb. In addition, even if expressed in the same cell type, clonal variation can affect protein characteristics. A pre-competitive, industrially relevant expression system would accelerate development of originator and follow-on products as a collaborative test case to develop innovative process technology, such as continuous manufacturing, process intensification strategies, and process analytical technologies. Advancements demonstrated with such a reference cell line could then be adopted by biopharmaceutical manufacturers and may result in improvements in the ability to prepare and define product quality attributes (PQAs), predict and tune PQAs through process control, and quantitatively correlate structural elements responsible for biological activity, among others.