Biosimilars and Interchangeable Biologics: Tactical Elements, 1st Edition (Hardback) book cover

Biosimilars and Interchangeable Biologics

Tactical Elements, 1st Edition

By Sarfaraz K. Niazi

CRC Press

575 pages | 23 Color Illus. | 41 B/W Illus.

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Description

What’s the Deal with Biosimilars?

Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.

Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Tactical Elements explores the development and manufacturing of biosimilars and targets challenges surrounding the creation of these products. This includes manufacturing, production costs, and intellectual property barriers, particularly in regulated markets (regulatory agencies are still in the process of developing guidelines). It addresses the complexity of biological drugs, and it discusses specific structural elements vital to the functionality, immunogenicity, and safety of biosimilar products.

Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume provides an overall understanding of the hurdles, difficulties, and practicalities of developing a strong plan. It introduces a step-by-step approach for creating a strategy that helps develop and manufacture a biosimilar product while reducing overall production costs and meeting the requirements of biosimilarity based on analytical and functional, pharmacokinetic, pharmacodynamic (where applicable), and nonclinical toxicology or toxicokinetic similarity (where appropriate) while remaining competitive in the market.

 

 

Table of Contents

Structural and Functional Elements

Basics

Multidimensional View

Primary Structure

Secondary Structure

Tertiary Structure

Quaternary Structure

Posttranslational Modification (PTM)

Protein Folding

Protein Structural Variability

Recombinant DNA

Bibliography

Immunogenicity Considerations

Introduction

Immune System

Antigens

Antibody

Protein Immunogenicity

Biosimilar Product Immunogenicity

Immunogenicity Testing

Conclusion

Bibliography

Product Development Strategies

Background

Selection of Product

Manufacturing System Selection

Cell Line Choice

Reference Product

Test Method Development

Specifications

Reverse Engineering

Analytical and Functional Similarity

Nonclinical Studies

Clinical Pharmacology Studies

Interchangeability Protocols

Regulatory Uncertainty

Legal Teams in Place

Commercialization Challenges

Bibliography

Stability and Formulation Considerations

Introduction

Formulation of Biosimilar Products

Common Formulation Elements

High Concentration Formulations

Stability Testing Guidance

Bibliography

Biosimilarity Tetrahedron

Tetrahedron Concept

Similarity Concept

Comparability versus Similarity

Analytical and Functional Similarity

Analytical Instrumentation

Identity

Purity

Potency

Safety

Clinical Data

Risk-Based Critical Quality Attributes

Nonclinical Data

Stages of Analytical Similarity

Level of Similarity

Statistical Modeling of Similarity Data

Interchangeability

Conclusion

Bibliography

Recombinant Expression Systems

Background

Expression System Development

Manipulations to Improve Yield

Mammalian Cells Expression Systems

Mammalian Cell Expression Improvements

Yeast Expression Systems

Insect Cells

Transgenic Animals

Cell Banks

Bibliography

Upstream Systems Optimization

Background

Bacterial Manufacturing Systems

Mammalian Manufacturing Systems

Yeast Cell Manufacturing Systems

Transgenic Animal Systems

Cell Lines and Characterization

Future Prospects

Bibliography

Downstream Systems Optimization

Introduction

Bacterial Downstream Processing

Mammalian Downstream

Yeast Downstream Processing

Insect Cell Processing

Transgenic Animals Processing

Bibliography

Single-Use Manufacturing Systems (SUMS)

Background

Safety of Single-Use Systems

Polymers and Additives

Regulatory Requirements

Risk Assessment

Single-Use Containers

Summary

Single-Use Mixing Systems

Connectors and Transfers

Filtration

Controls

Filling and Finishing Systems

Environmental Concerns

Bibliography

Commercial Manufacturing Overview

Introduction

Media

Culture Growth

Process Overview

Process Maturity

Validation

Scale-Up

Specific Scale-Up Issues

Specific Economy Issues

Process Materials

Environment Control

Biosafety Levels

Good Manufacturing Controls of Active Pharmaceutical Ingredients

Cleaning Procedures

Processing and Filling

Laboratory Testing

Laboratory Controls

Documentation

Bibliography

Outsourcing Considerations

Background

Value of Outsourcing

Factors to Consider in Outsourcing

Key Requirements

What to Outsource?

Cell Line Suppliers

CMOs

Biopharmaceutical Support Services

Analytical Support Providers

Contract Research Organizations

Product Development Services

Fill and Finish Providers

Legal Matters

Managing Outsourcing

Outlook

About the Author

Sarfaraz K. Niazi, PhD, is the founding executive chairman of Therapeutic Proteins International LLC, a world-class pure-play developer and manufacturer of biosimilar and interchangeable recombinant biologics, headquartered in Chicago. Dr. Niazi began his career teaching pharmacy at the University of Illinois (1972–1988), where he became a tenured professor. He then entered the pharmaceutical industry at Abbott International, becoming a Volwiler Fellow. He left Abbott in 1995 with a passion for making high-cost biological drugs affordable. Dr. Niazi set up several ex-U.S. biosimilar companies and, in 2003, established Therapeutic Proteins International, the only U.S. integrated company of its kind to date.

Subject Categories

BISAC Subject Codes/Headings:
MED009000
MEDICAL / Biotechnology
MED071000
MEDICAL / Pharmacology
SCI010000
SCIENCE / Biotechnology
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical