A cross-industry forum on benchmarking critical quality attribute identification and linkage to process characterization studies

Demmon, Sarah; Bhargava, Swapnil; Ciolek, Doreen; Halley, Jennifer; Jaya, N.; Joubert, Marisa K.; Koepf, Edward K.; Smith, Prudence; Trexler-Schmidt, Melody; Tsai, Philip H.

doi:10.1016/j.biologicals.2020.06.008

Cited by 14 publications

(7 citation statements)

References 3 publications

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“…Within the pharmaceutical and fine chemical industries, the ability to fulfill quality-critical parameters is one of the key goals of process development, but these aspects are typically not investigated before moving toward scale-up studies. Most recent industrial practices, described by Tsai and co-workers, 324 describe how to systematically include quality considerations across all phases, including reaction optimization.…”

Section: Scale-up Considerations Within Reaction Optimizationmentioning

confidence: 99%

A Brief Introduction to Chemical Reaction Optimization

et al. 2023

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From the start of a synthetic chemist’s training, experiments are conducted based on recipes from textbooks and manuscripts that achieve clean reaction outcomes, allowing the scientist to develop practical skills and some chemical intuition. This procedure is often kept long into a researcher’s career, as new recipes are developed based on similar reaction protocols, and intuition-guided deviations are conducted through learning from failed experiments. However, when attempting to understand chemical systems of interest, it has been shown that model-based, algorithm-based, and miniaturized high-throughput techniques outperform human chemical intuition and achieve reaction optimization in a much more time- and material-efficient manner; this is covered in detail in this paper. As many synthetic chemists are not exposed to these techniques in undergraduate teaching, this leads to a disproportionate number of scientists that wish to optimize their reactions but are unable to use these methodologies or are simply unaware of their existence. This review highlights the basics, and the cutting-edge, of modern chemical reaction optimization as well as its relation to process scale-up and can thereby serve as a reference for inspired scientists for each of these techniques, detailing several of their respective applications.

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Section: Scale-up Considerations Within Reaction Optimizationmentioning

confidence: 99%

A Brief Introduction to Chemical Reaction Optimization

et al. 2023

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“…Through a survey conducted among various companies in a multinational collaboration partnership, they examined the practices for recognizing CQAs and their links to process parameter identification. The findings indicate that these companies utilize similar methods and timing to classify CQAs during the process development, emphasizing the significance of relating CQAs to process characterization studies, which have implications for control strategies and lifecycle management [29].…”

Section: Advancements In Pharmaceuticalmentioning

confidence: 93%

Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality

Azeeze,

Nunavath,

Singh

et al. 2023

Drug Res (Stuttg)

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The pharmaceutical industry has embraced the quality-by-design (QbD) approach as a promising development, formulation and manufacturing strategy. QbD provides a systematic and science-based framework for designing and producing high-quality products, with a particular focus on identifying, assessing and controlling risks throughout the development process. This review aims to assess the benefits of implementing QbD in pharmaceutical processes, evaluate its impact on regulatory compliance and explore its potential to enhance drug product quality. The primary objective of this review is to evaluate the influence of QbD on pharmaceutical development and manufacturing processes. It also seeks to examine the regulatory requirements associated with the implementation of QbD and highlight the advantages of this approach in terms of product quality and cost-effectiveness. Additionally, the review aims to explore the potential of QbD in improving the safety and efficacy of drug products. The QbD approach holds tremendous potential to revolutionize the pharmaceutical industry by optimizing drug development & manufacturing processes, reducing costs and enhancing product quality and consistency. However, implementing QbD requires a comprehensive understanding of the underlying science, as well as strict adherence to regulatory requirements in drug development and manufacturing. In conclusion, by embracing the QbD approach, the pharmaceutical industry can ensure the production of safe, effective and regulation-compliant products while simultaneously improving process efficiency. This strategic shift toward QbD represents a pivotal step in advancing pharmaceutical research and manufacturing capabilities, ultimately benefiting both the industry and more importantly, patients worldwide.

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“…NMR Spectroscopy is one of the most powerful techniques to decipher the structural information of biomolecules in solution at atomic resolution. Magnetically active nuclei like 1 H, 15 N, and 13 C behave like a small spinning magnets, and when kept under the in uence of an external magnetic eld, will precess about the applied magnetic eld. The frequency of precession depends upon chemical environment of the atom and gives rise to a particular resonance frequency, known as the Larmor frequency (ω).…”

Section: Nmr Spectroscopymentioning

confidence: 99%

Comparative physicochemical and structural characterisation studies establish high Biosimilarity between BGL-ASP and Reference Insulin Aspart

Ghade,

Thappa,

Lona

et al. 2023

Preprint

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Biosimilar insulin analogues are increasing market access for diabetic patients globally. Scientific establishment of biosimilarity is cornerstone of this key change in the medical landscape. BGL-ASP is a biosimilar insulin aspart developed by BioGenomics Limited, India. BioGenomics has considered a stepwise approach in generating the totality of evidence required to establish similarity with reference product. Insulin aspart is a recombinant rapid-acting human insulin analogue utilised in the treatment of type-1 and type-2 diabetes mellitus. The single amino acid substitution at position B28 where proline is replaced with aspartic acid results in a decreased propensity to form hexamers, thus increasing the absorption rate on subcutaneous administration compared to native insulin. In order to establish the safety and efficacy of BGL-ASP, the critical quality attributes (CQAs) of BGL-ASP are identified based on the impact created on biological activity, pharmacokinetic/ pharmacodynamic (PK/PD), immunogenicity and safety. The CQAs of insulin aspart are related to product structure, purity and functionality and are characterised using a series of state-of-the-art orthogonal analytical tools. The primary protein sequence, the secondary, tertiary and quaternary structure are found to be highly similar for BGL-ASP and reference product. The product related impurities of insulin aspart and the assay content are determined using high performance liquid chromatography (HPLC) based analysis and is similar for BGL-ASP and reference insulin aspart sourced from United States of America (US), Europe Union (EU) and India. The safety, efficacy and immunogenicity of BGL-ASP is also found to be comparable with reference product and is confirmed through the clinical trials conducted as recommended by International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) and European Medicines Agency (EMA) guidelines. The data encompassed in this study demonstrates that reference insulin aspart and BGL-ASP are highly similar in terms of structural, physicochemical, and biological properties, thus confirming its safety and efficacy for usage as potential alternative economical medicinal treatment for diabetes mellitus.

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A cross-industry forum on benchmarking critical quality attribute identification and linkage to process characterization studies

Cited by 14 publications

References 3 publications

A Brief Introduction to Chemical Reaction Optimization

A Brief Introduction to Chemical Reaction Optimization

Quality by Design in Pharmaceuticals: A Review of its Impact on Regulatory Compliance and Product Quality

Comparative physicochemical and structural characterisation studies establish high Biosimilarity between BGL-ASP and Reference Insulin Aspart

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