Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products

Desai, Kashappa Goud H.; Obayashi, Hirokazu; Colandene, James D.; Nesta, Douglas P.

doi:10.1016/j.xphs.2018.03.017

Cited by 13 publications

(5 citation statements)

References 30 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, as rodents differ in their metabolism and physiology from humans, swine, like no other animal model, faithfully reproduces the human organism [249]. Animal models should be selected considering aspects such as correspondence with the route of administration, dose, experimental design, physiological state, and the stability of the nanomaterial in biological media [250].…”

Section: Selection Of Animal Models and Test Parametersmentioning

confidence: 99%

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

et al. 2022

View full text Add to dashboard Cite

Nanomedicine plays an essential role in developing new therapies through novel drug delivery systems, diagnostic and imaging systems, vaccine development, antibacterial tools, and high-throughput screening. One of the most promising drug delivery systems are nanoparticles, which can be designed with various compositions, sizes, shapes, and surface modifications. These nanosystems have improved therapeutic profiles, increased bioavailability, and reduced the toxicity of the product they carry. However, the clinical translation of nanomedicines requires a thorough understanding of their properties to avoid problems with the most questioned aspect of nanosystems: safety. The particular physicochemical properties of nano-drugs lead to the need for additional safety, quality, and efficacy testing. Consequently, challenges arise during the physicochemical characterization, the production process, in vitro characterization, in vivo characterization, and the clinical stages of development of these biopharmaceuticals. The lack of a specific regulatory framework for nanoformulations has caused significant gaps in the requirements needed to be successful during their approval, especially with tests that demonstrate their safety and efficacy. Researchers face many difficulties in establishing evidence to extrapolate results from one level of development to another, for example, from an in vitro demonstration phase to an in vivo demonstration phase. Additional guidance is required to cover the particularities of this type of product, as some challenges in the regulatory framework do not allow for an accurate assessment of NPs with sufficient evidence of clinical success. This work aims to identify current regulatory issues during the implementation of nanoparticle assays and describe the major challenges that researchers have faced when exposing a new formulation. We further reflect on the current regulatory standards required for the approval of these biopharmaceuticals and the requirements demanded by the regulatory agencies. Our work will provide helpful information to improve the success of nanomedicines by compiling the challenges described in the literature that support the development of this novel encapsulation system. We propose a step-by-step approach through the different stages of the development of nanoformulations, from their design to the clinical stage, exemplifying the different challenges and the measures taken by the regulatory agencies to respond to these challenges.

show abstract

Section: Selection Of Animal Models and Test Parametersmentioning

confidence: 99%

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

et al. 2022

View full text Add to dashboard Cite

show abstract

“…It is, however, important to realize that, also for non-GLP studies, the regulators do expect that necessary measures are taken to have trustworthy, unbiased outcomes and that research data are retrievable on demand. The Japanese regulators are particularly very strict when it comes to availability of data (Desai et al 2018). Regulators have the authorization by law to look into your research data.…”

Section: 1mentioning

confidence: 99%

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Bespalov¹,

Michel²,

Steckler³

2020

Handbook of Experimental Pharmacology

View full text Add to dashboard Cite

show abstract

“…For example, the demand and production of biofuels from biomass and agricultural residues was increased in the United States of America mainly due to the legislation enacted by the Energy Independence and Security Act of 2007 (Castillo-Villar et al 2017). In the pharmaceutical industry, governmental regulations should contemporarily ensure the triplet Bqualitysafety -efficacy^of renewable feedstock-based medications (Desai et al 2018) and alleviate sectoral barriers to growth (Festel 2011). In particular, owing to the often volatile physicochemical properties of renewable feedstocks, regulatory requirements concern about potential changes in the properties of excipients and biopharmaceuticals' API during the scale-up and down-stream production processes that could hinder manufacturing consistency and reproducibility (Parr et al 2016).…”

Section: Supply Chain (Re)configuration Driversmentioning

confidence: 99%

“…In particular, owing to the often volatile physicochemical properties of renewable feedstocks, regulatory requirements concern about potential changes in the properties of excipients and biopharmaceuticals' API during the scale-up and down-stream production processes that could hinder manufacturing consistency and reproducibility (Parr et al 2016). During the last decades, Desai et al (2018) report that pharmaceutical industry experts and regulators from the United States, Europe, and Japan have jointly worked towards streamlining, harmonising, and accelerating the development and approval processes of new bio-based pharmaceutical products. Institutional arrangements and regulations could benchmark market needs and drive the use of renewable feedstocks for specific offerings; then technology advancements could be supported to promote value creation in a synergistic manner.…”

Section: Supply Chain (Re)configuration Driversmentioning

confidence: 99%

Mapping supply dynamics in renewable feedstock enabled industries: A systems theory perspective on ‘green’ pharmaceuticals

Tsolakis

Srai

2018

Oper Manag Res

View full text Add to dashboard Cite

This paper provides a multi-stage multi-layer mapping methodology for capturing the macro-level supply chain dynamics that govern industrial systems using renewable feedstocks. The mapping approach combines the Industrial Systems Mapping and System Dynamics principles to systematically capture the interrelations across: (i) institutional players, (ii) sector specialists, (iii) products and intermediates, (iv) production operations, and (v) firms within the supply chain. The interfaces are further explored at four interconnected and mutually interacting theme areas of analysis, namely: (i) renewable chemical feedstocks, (ii) production technologies, (iii) target markets, and (iv) value and economic viability. We demonstrate the applicability of our approach by mapping the dynamics in industrial systems for the production of 'green' pharmaceuticals, particularly via the illustrative case of paracetamol. Through the use of the proposed integrated mapping process the case study demonstrates the principal interrelationships and inter-firm dynamics between the different layers of analysis. Three main drivers are identified that could enhance supply network transformations for improved viability of these developing industrial systems, namely: (i) regulatory conformance with market requirements, (ii) system level feasibility assessment of given renewable feedstocks, and (iii) target market volume demand. The causal feedback elements of the provided mapping technique indicate that it could support the analysis of industrial systems' transformation dynamics enabled by renewable feedstocks. The standardisation of the methodology and its elements provides for an effective visualisation technique with cross-industry relevance.

show abstract

Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products

Cited by 13 publications

References 30 publications

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

The Hitchhiker’s Guide to Human Therapeutic Nanoparticle Development

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

Mapping supply dynamics in renewable feedstock enabled industries: A systems theory perspective on ‘green’ pharmaceuticals

Contact Info

Product

Resources

About