Quality by design for biopharmaceuticals

  title={Quality by design for biopharmaceuticals},
  author={Anurag Singh Rathore and Helen Winkle},
  journal={Nature Biotechnology},
The US Food and Drug Administration's 'quality by design' approach is likely to transform the manufacture of biologics. 

Figures, Tables, and Topics from this paper

Quality by Design risk assessments supporting approved antibody products
A global regulatory initiative that enhances pharmaceutical development through the design of the manufacturing process and controls to consistently deliver a product that is safe and effective for humans and animals. Expand
Quality by design for biopharmaceuticals : principles and case studies
DESCRIPTION The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and JapaneseExpand
Development of novel pharmaceutical forms for oral administration of bioactive agents
Tese de doutoramento em Ciencias Farmaceuticas, na especialidade de Tecnologia Farmaceutica, apresentada a Faculdade de Farmacia da Universidade de Coimbra
Development of rational bioprocess design strategies for a clinically relevant protein candidate
Application of Model-Free and Model-Based Quality-by-Control (QbC) for the Efficient Design of Pharmaceutical Crystallization Processes
The design of pharmaceutical crystallization processes is a challenging engineering problem because of the specific and versatile quality requirements of the end-product, amplified by the tight reg...
Complete or periodic continuity in continuous manufacturing platforms for production of monoclonal antibodies?
This research presents a novel and scalable approaches towards the development of a continuous integrated platform for the manufacturing of monoclonal antibodies that has the potential to transform the biotherapeutic market. Expand
Lyophilization of Biologics: An FDA Perspective
The process of lyophilization is a complex, multistep process that requires a sound understanding of both product and process-related attributes to ensure higher operational efficiency and consistently acceptable final product. Expand
Application of Quality by Design for the Development of Biopharmaceuticals
Abstract In biopharmaceutical industries/companies the product quality has an imperative role. The quality by design (QbD) concept has been significantly applied to biopharmaceuticals andExpand
Challenges and Opportunities for Biotech Quality by Design
This chapter describes bioprocessing schemes for both liquid and lyophilized drug products and discusses the role of process analytical technologies (PAT) and design of experiments (DoEs) as complementary approaches in upstream and downstream process could serve to support the overall development and manufacture of a quality product. Expand
Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic.
  • A. Rathore
  • Computer Science, Medicine
  • Trends in biotechnology
  • 2016
A case study is presented that illustrates the step-by-step development using QbD of a purification process for the production of a biosimilar product: granulocyte colony-stimulating factor (GCSF). Expand


Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products.
While the main focus of this document is assay design considerations, it provides scientific focus and background to the various assay performance parameters necessary for developing a valid assay. Expand
Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics.
This document provides scientific recommendations based on the experience of the authors for the development of cell-based assays for the detection of neutralizing antibodies in non-clinical and clinical studies. Expand
Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist.
Two ELISA assays for detection of free and total DDAbs were developed and analytically validated and served two purposes during the clinical development program, to pre-screen patients for pre-existing antibodies and monitor patients for increasing antibody titers as a surrogate for eminent thrombocytopenia. Expand
Applications of process analytical technology to crystallization processes.
The concept of PAT is introduced and its application to crystallization processes is discussed through review of several case studies and a variety of in situ analytical methods combined with chemometric tools for analysis of multivariate process information provide a basis for future improvements in modeling, simulation, and control of crystallization methods. Expand
Overcoming obstacles to monoclonal antibody product development and approval.
  • K. Stein
  • Medicine
  • Trends in biotechnology
  • 1997
Some of the obstacles to successful product development are discussed and suggestions to overcoming them are offered. Expand
Clinical Trials: Investing in risk management
An accident, a mistake, a misjudgment can spell disaster if your company is unprepared.
Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control
Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications into a science-based pharmaceutical quality assessment. Expand
Defining Process Design Space for Biotech Products: Case Study of Pichia pastoris Fermentation
It is shown that the fermentation unit operation is very robust with a wide design space and no critical operating parameters and can be extended to other biotech unit operations and processes that can be scaled down and characterized at small scale. Expand
Application of Multivariate Analysis toward Biotech Processes: Case Study of a Cell‐Culture Unit Operation
The feasibility of using multivariate data analysis (MVDA) for supporting some of the key activities that are required for successful manufacturing of biopharmaceutical products is examined, demonstrating the effectiveness of MVDA as a tool for extracting process knowledge. Expand
Current and future issues in the manufacturing and development of monoclonal antibodies.
There are a number of regulatory hurdles in initial and ongoing antibody development, independent of manufacturing strategy, that are described to help prevent unnecessary delays. Expand