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. 

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.

Quality by design for biopharmaceuticals : principles and case studies

Quality by Design is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process to yield a consistent and high-quality pharmaceutical product.

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...

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.

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.

Application of Quality by Design Paradigm to the Manufacture of Protein Therapeutics

Application of Quality by Design Paradigm to the Manufacture of Protein Therapeutics and its implications for drug development.

Multivariate Synergies in Pharmaceutical Roll Compaction : The quality influence of raw materials and process parameters by design of experiments

Roll compaction is a continuous process commonly used in the pharmaceutical industry for dry granulation of moisture and heat sensitive powder blends. It is intended to increase bulk density and im



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.

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.

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

It is shown that implementing this analytical scheme allows us to meet two of the key goals that have been outlined for PAT, that is, “variability is managed by the process” and “product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions.