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Because of many misconceptions, the biological drug manufacturing
industry does not fully utilize disposable components, despite
their wide availability. These misconceptions include concerns for
the quality of materials, running costs, scalability, the level of
automation possible, and the training of staff needed to include
these components in existing bioprocessing systems. Not fully
realizing the long-term benefits, many manufacturers are unwilling
to discard investments made in fixed equipment and traditional
stainless steel systems. Regulatory and environmental concerns,
however, will eventually compel manufacturers to adopt disposable
systems. Making a strong case for disposables, Disposable
Bioprocessing Systems demonstrates the true potential of these
systems. Written by a researcher and professor with hands-on
experience in designing, establishing, and validating biological
manufacturing facilities worldwide, and creating model facilities
using maximum disposable technology, this book is the first
comprehensive introduction to understanding disposable systems. It
gives an overview of the current state of the disposable
bioprocessing industry, resolves all controversial issues, and
guides readers in choosing disposable components that meet their
needs. An important chapter on safety addresses facts and myths
about the use of plastics and elastomers-including the issue of
leaching-and how to ensure regulatory compliance. Helping readers
understand their choices, the book describes the equipment and
systems available to prepare the starting materials for the
manufacturing of biological drugs-from disposable containers to
filters. The author also discusses costs, regulations, and concerns
about waste disposal, and shares his predictions for the future of
the disposable bioprocessing industry. A practical manual for those
interested in the transition to disposable systems, this book will
also interest students of bioprocessing. It offers a timely view of
disposable bioprocessing technology as a "game changer" that will
facilitate developing new drugs and conducting research in the
emerging field of stem cells and gene therapy.
Before now, biological systems could only be expressed in terms of
linear relationships, however, as knowledge grows and new
techniques of analysis on biological systems is made available, we
are realizing the non-linearity of these systems. The concepts and
techniques of nonlinear analysis allow for more realistic and
accurate models in science. The Future of Pharmaceuticals: A
Nonlinear Analysis provides an opportunity to understand the
non-linearity of biological systems and its application in various
areas of science, primarily pharmaceutical sciences. This book will
benefit professionals in pharmaceutical industries, academia, and
policy who are interested in an entirely new approach to how we
will treat disease in the future. Key Features: Addresses a new
approach of nonlinear analysis. Applies a theory of projection to
chalk out the future, instead of basing on linear evolution.
Provides an opportunity to better understand the non-linearity in
biological systems and its applications in various areas of
science, primarily pharmaceutical sciences. Helps change the
thought process for those looking for answers to their questions
which they do not find in the linear relationship approach.
Encourages a broader perspective for the creative process of drug
development.
Unique and timely volume as mRNA is a hot area of research making
great strides. Covers the full-scale production systems that are
needed to develop vaccines as well as elements of data needed to
secure the IND approvals. Introduces a commercial-scale
manufacturing process using novel techniques like the PCR, in
addition to the traditional plasmid DNA. First book that offers
commercial technology for developing and large-scale supply of mRNA
products. Renowned author and entrepreneur in the field of drug
discovery and production.
Before now, biological systems could only be expressed in terms of
linear relationships, however, as knowledge grows and new
techniques of analysis on biological systems is made available, we
are realizing the non-linearity of these systems. The concepts and
techniques of nonlinear analysis allow for more realistic and
accurate models in science. The Future of Pharmaceuticals: A
Nonlinear Analysis provides an opportunity to understand the
non-linearity of biological systems and its application in various
areas of science, primarily pharmaceutical sciences. This book will
benefit professionals in pharmaceutical industries, academia, and
policy who are interested in an entirely new approach to how we
will treat disease in the future. Key Features: Addresses a new
approach of nonlinear analysis. Applies a theory of projection to
chalk out the future, instead of basing on linear evolution.
Provides an opportunity to better understand the non-linearity in
biological systems and its applications in various areas of
science, primarily pharmaceutical sciences. Helps change the
thought process for those looking for answers to their questions
which they do not find in the linear relationship approach.
Encourages a broader perspective for the creative process of drug
development.
More than 20 billion dollars worth of biopharmaceuticals are
scheduled to go off-patent by 2006. Given the strong political
impetus and the development of technological tools that can answer
the questions regulatory authorities may raise, it is inevitable
that the FDA and EMEA will allow biogeneric or biosimilar products.
Even with all the regulatory wrinkles yet to be ironed out, generic
or similar biological products are soon to become a reality.
Handbook of Biogeneric Therapeutic Proteins is the first book to
review and analyze the status of biotechnology, regulatory
environment, manufacturing methodologies, testing requirements and
intellectual property issues. The book provides complete and
thorough coverage of the regulatory and technological challenges of
developing generic therapeutic proteins and how to prepare detailed
regulatory and manufacturing plans and policies. The author
includes information on establishing a manufacturing system,
securing regulatory approval, and setting up facilities to
manufacture raw materials and prepare finished products. He also
supplies details about the Chemistry, Manufacturing, and Controls
(CMC) section of the FDA's New Drug Application for Biological
Products. In brief, the book supplies everything a manufacturer
would need to plan the development of biogeneric products and
complete the process of regulatory filing. Waiting for the FDA to
issue guidelines is a mistake. The scramble to catch up could leave
your company way behind in the game. Your organization needs to
begin developing and characterizing genetically modified cells now
and to complete initial GMP production runs through a CRO to get
ready for the newer testing the FDA might impose. Packed with
tables and figures that provide speedy access to precise, timely
data, including full formulation details on all FDA approved
biological product, this book contains a broad range of resource
materials about suppliers, manufacturers, and testing faciliti
Preformulation studies are the physical, chemical, and biological
studies needed to characterize a drug substance for enabling the
proper design of a drug product, whereas the effectiveness of a
drug product is determined during the formulation studies phase.
Though the two disciplines overlap in practice, each is a
significantly distinct phase of new drug development. Entirely
focused on preformulation principles, this fully revised and
updated Handbook of Preformulation: Chemical, Biological, and
Botanical Drugs, Second Edition provides detailed descriptions of
preformulation methodologies, gives a state-of-the-art description
of each technique, and lists the currently available tools useful
in providing a comprehensive characterization of a new drug entity.
Features: Addresses the preformulation studies of three different
types of new active entities - chemical, biological, and botanical,
which is the latest established class of active ingredient
classified by the FDA Illustrates the activities comprised in
preformulation studies and establishes a method of tasking for drug
development projects Includes extensive flow charts for
characterization decision making Gives extensive theoretical
treatment of principles important for testing dissolution,
solubility, stability, and solid state characterization Includes
over 50% new material
While liquid drugs do not share the compression problems of solid
dosage forms, the filling problems of powder dosage forms, or the
consistency problems of semisolid dosage forms, they do have their
own set of considerations in the formulation and manufacturing
stages. Highlights from Liquid Products, Volume Three include:
practical details involved in complying with the current good
manufacturing practice requirements in liquid manufacturing access
to what an FDA auditor would be looking for during a liquid
manufacturing audit issues that may arise during a US FDA
inspection the protocols used for stability testing for new drugs
and new dosage forms, drawn from the most current ICH guidelines
The average cost of an uncomplicated patent application filing is
about $10,000. This high cost can leave thousands of inventors out
in the cold. Filing Patents Online: A Professional Guide is a
complete manual that walks inventors through each step of filing
and prosecuting the patent online at a fraction of the cost. The
online filing system recommended in the book allows continuous
monitoring of the review status and for a much faster approval than
the traditional route. Drawing from the many years of the author's
experience as both an inventor and a patent agent, this guide
teaches the methods of research, planning, and the art of writing
winning claims that will result in commercially valuable patents.
The Handbook of Pharmaceutical Manufacturing Formulations, Third
Edition: Volume Six, Sterile Products is an authoritative and
practical guide to the art and science of formulating drugs for
commercial manufacturing. With thoroughly revised and expanded
content, this sixth volume of a six-volume set, compiles data from
FDA and EMA new drug applications, patents and patent applications,
and other sources of generic and proprietary formulations including
author's own experience, to cover the broad spectrum of cGMP
formulations and issues in using these formulations in a commercial
setting. A must-have collection for pharmaceutical manufacturers,
educational institutions, and regulatory authorities, this is an
excellent platform for drug companies to benchmark their products
and for generic companies to formulate drugs coming off patent.
Features: Largest source of authoritative and practical
formulations, cGMP compliance guidance and self-audit suggestions
Differs from other publications on formulation science in that it
focuses on readily scalable commercial formulations that can be
adopted for cGMP manufacturing Tackles common difficulties in
formulating drugs and presents details on stability testing,
bioequivalence testing, and full compliance with drug product
safety elements Written by a well-recognized authority on drug and
dosage form development including biological drugs and alternative
medicines
The Handbook of Pharmaceutical Manufacturing Formulations, Third
Edition is an authoritative and practical guide to the art and
science of formulating drugs for commercial manufacturing. With
thoroughly revised and expanded content, this six-volume set
compiles data from FDA new drug applications, patent applications,
and other sources of generic and proprietary formulations to cover
the broad spectrum of GMP formulations and issues in using these
formulations in a commercial setting. A must-have collection for
pharmaceutical manufacturers, educational institutions, and
regulatory authorities, this is an excellent platform for drug
companies to benchmark their products and for generic companies to
formulate drugs coming off patent.
Providing methodologies that can serve as a reference point for new
formulations, the second volume covers uncompressed solids, which
include formulations of powders, capsules, powders ready for
reconstitution, and other similar products. Highlights from
Uncompressed Solid Products, Volume Two include: the fundamental
issues of good manufacturing practices formulations for more than
400 pharmaceutical products, including currently approved products
and innovative products such as small proteins, instantly
liquifiable powders, and nanoparticles access to US FDA guidelines,
as well as all major guidelines around the world identification and
inclusion of the most often approved capsules and powders in the US
Over-the-Counter products comprise a special category of healthcare
products. While these formulations have much in common with their
prescription counterparts, they are presented in this series
separately because of their development approach taken, labeling
considerations required, and support available from suppliers of
ingredients in designing these products. Highlights from
Over-the-Counter Products, Volume Five include: solids, liquids,
and suspensions practical advice on how to bring manufacturing
practices into compliance with regulatory requirements cGMP
considerations in great detail a large number of formulations of
coatings of solid dosage forms
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: Strategic
Elements explores the strategic planning side of biosimilar drugs
and targets issues surrounding biosimilars that are linked to legal
matters. This includes principal patents and intellectual property,
regulatory pathways, and concerns about affordability on a global
scale. It addresses the complexity of biosimilar products, and it
discusses the utilization of biosimilars and related biological
drugs in expanding world markets. Of specific interest to
practitioners, researchers, and scientists in the biopharmaceutical
industry, this volume examines the science, technology, finance,
legality, ethics, and politics of biosimilar drugs. It considers
strategic planning elements that include an overall understanding
of the history and the current status of the art and science of
biosimilars, and it provides detailed descriptions of the legal,
regulatory, and commercial characteristics. The book also presents
a global strategy on how to build, take to market, and manage the
next generation of biosimilars throughout their life cycle.
Biological drug and vaccine manufacturing has quickly become one of
the highest-value fields of bioprocess engineering, and many
bioprocess engineers are now finding job opportunities that have
traditionally gone to chemical engineers. Fundamentals of Modern
Bioprocessing addresses this growing demand. Written by experts
well-established in the field, this book connects the principles
and applications of bioprocessing engineering to healthcare product
manufacturing and expands on areas of opportunity for qualified
bioprocess engineers and students. The book is divided into two
sections: the first half centers on the engineering fundamentals of
bioprocessing; while the second half serves as a handbook offering
advice and practical applications. Focused on the fundamental
principles at the core of this discipline, this work outlines every
facet of design, component selection, and regulatory concerns. It
discusses the purpose of bioprocessing (to produce products
suitable for human use), describes the manufacturing technologies
related to bioprocessing, and explores the rapid expansion of
bioprocess engineering applications relevant to health care product
manufacturing. It also considers the future of bioprocessing-the
use of disposable components (which is the fastest growing area in
the field of bioprocessing) to replace traditional stainless steel.
In addition, this text: Discusses the many types of genetically
modified organisms Outlines laboratory techniques Includes the most
recent developments Serves as a reference and contains an extensive
bibliography Emphasizes biological manufacturing using recombinant
processing, which begins with creating a genetically modified
organism using recombinant techniques Fundamentals of Modern
Bioprocessing outlines both the principles and applications of
bioprocessing engineering related to healthcare product
manufacturing. It lays out the basic concepts, definitions, methods
and applications of bioprocessing. A single volume comprehensive
reference developed to meet the needs of students with a
bioprocessing background; it can also be used as a source for
professionals in the field.
Summary: The focus of this book is on how the U.S. FDA will approve
biosimilar drugs, as learned from recent approvals by the FDA.
Understanding the limitations of the statutory limits and
non-inferiority testing are presented as tools to obviate patient
trials and minimize testing of immunogenicity. An in-depth
scientific, mathematical and statistical view of the tools required
to establish biosimilarity of biological drugs of different
complexity -- a must for every developer of biosimilars. Features:
First comprehensive analysis based on new guidelines and approval
packages of several biosimilars Presents the first approach to
challenge FDA in reducing or eliminating any testing in patients.
Provides a comprehensive understanding of the U.S. statutory
requirements vis-a-vis the regulatory guidelines Provides model CQA
and Analytical Similarity testing protocols for cytokines and
monoclonal antibodies Allow creation of a fast-to-market pathway to
develop biosimilars
Biological drug and vaccine manufacturing has quickly become one of
the highest-value fields of bioprocess engineering, and many
bioprocess engineers are now finding job opportunities that have
traditionally gone to chemical engineers. Fundamentals of Modern
Bioprocessing addresses this growing demand. Written by experts
well-established in the field, this book connects the principles
and applications of bioprocessing engineering to healthcare product
manufacturing and expands on areas of opportunity for qualified
bioprocess engineers and students. The book is divided into two
sections: the first half centers on the engineering fundamentals of
bioprocessing; while the second half serves as a handbook offering
advice and practical applications. Focused on the fundamental
principles at the core of this discipline, this work outlines every
facet of design, component selection, and regulatory concerns. It
discusses the purpose of bioprocessing (to produce products
suitable for human use), describes the manufacturing technologies
related to bioprocessing, and explores the rapid expansion of
bioprocess engineering applications relevant to health care product
manufacturing. It also considers the future of bioprocessing-the
use of disposable components (which is the fastest growing area in
the field of bioprocessing) to replace traditional stainless steel.
In addition, this text: Discusses the many types of genetically
modified organisms Outlines laboratory techniques Includes the most
recent developments Serves as a reference and contains an extensive
bibliography Emphasizes biological manufacturing using recombinant
processing, which begins with creating a genetically modified
organism using recombinant techniques Fundamentals of Modern
Bioprocessing outlines both the principles and applications of
bioprocessing engineering related to healthcare product
manufacturing. It lays out the basic concepts, definitions, methods
and applications of bioprocessing. A single volume comprehensive
reference developed to meet the needs of students with a
bioprocessing background; it can also be used as a source for
professionals in the field.
Because of many misconceptions, the biological drug manufacturing
industry does not fully utilize disposable components, despite
their wide availability. These misconceptions include concerns for
the quality of materials, running costs, scalability, the level of
automation possible, and the training of staff needed to include
these components in existing bioprocessing systems. Not fully
realizing the long-term benefits, many manufacturers are unwilling
to discard investments made in fixed equipment and traditional
stainless steel systems. Regulatory and environmental concerns,
however, will eventually compel manufacturers to adopt disposable
systems. Making a strong case for disposables, Disposable
Bioprocessing Systems demonstrates the true potential of these
systems. Written by a researcher and professor with hands-on
experience in designing, establishing, and validating biological
manufacturing facilities worldwide, and creating model facilities
using maximum disposable technology, this book is the first
comprehensive introduction to understanding disposable systems. It
gives an overview of the current state of the disposable
bioprocessing industry, resolves all controversial issues, and
guides readers in choosing disposable components that meet their
needs. An important chapter on safety addresses facts and myths
about the use of plastics and elastomers-including the issue of
leaching-and how to ensure regulatory compliance. Helping readers
understand their choices, the book describes the equipment and
systems available to prepare the starting materials for the
manufacturing of biological drugs-from disposable containers to
filters. The author also discusses costs, regulations, and concerns
about waste disposal, and shares his predictions for the future of
the disposable bioprocessing industry. A practical manual for those
interested in the transition to disposable systems, this book will
also interest students of bioprocessing. It offers a timely view of
disposable bioprocessing technology as a "game changer" that will
facilitate developing new drugs and conducting research in the
emerging field of stem cells and gene therapy.
The Handbook of Pharmaceutical Manufacturing Formulations, Third
Edition: Volume Four, Semisolid Products is an authoritative and
practical guide to the art and science of formulating drugs for
commercial manufacturing. With thoroughly revised and expanded
content, this fourth volume of a six-volume set, compiles data from
FDA and EMA new drug applications, patents and patent applications,
and other sources of generic and proprietary formulations including
author's own experience, to cover the broad spectrum of cGMP
formulations and issues in using these formulations in a commercial
setting. A must-have collection for pharmaceutical manufacturers,
educational institutions, and regulatory authorities, this is an
excellent platform for drug companies to benchmark their products
and for generic companies to formulate drugs coming off patent.
Features: Largest source of authoritative and practical
formulations, cGMP compliance guidance and self-audit suggestions
Differs from other publications on formulation science in that it
focuses on readily scalable commercial formulations that can be
adopted for cGMP manufacturing Tackles common difficulties in
formulating drugs and presents details on stability testing,
bioequivalence testing, and full compliance with drug product
safety elements Written by a well-recognized authority on drug and
dosage form development including biological drugs and alternative
medicines
The Handbook of Pharmaceutical Manufacturing Formulations, Third
Edition: Volume Five, Over-the-Counter Products is an authoritative
and practical guide to the art and science of formulating drugs for
commercial manufacturing. With thoroughly revised and expanded
content, this fifth volume of a six-volume set, compiles data from
FDA and EMA new drug applications, patents and patent applications,
and other sources of generic and proprietary formulations including
author's own experience, to cover the broad spectrum of cGMP
formulations and issues in using these formulations in a commercial
setting. A must-have collection for pharmaceutical manufacturers,
educational institutions, and regulatory authorities, this is an
excellent platform for drug companies to benchmark their products
and for generic companies to formulate drugs coming off patent.
Features: Largest source of authoritative and practical
formulations, cGMP compliance guidance and self-audit suggestions
Differs from other publications on formulation science in that it
focuses on readily scalable commercial formulations that can be
adopted for cGMP manufacturing Tackles common difficulties in
formulating drugs and presents details on stability testing,
bioequivalence testing, and full compliance with drug product
safety elements Written by a well-recognized authority on drug and
dosage form development including biological drugs and alternative
medicines
The Handbook of Pharmaceutical Manufacturing Formulations, Third
Edition: Volume Three, Liquid Products is an authoritative and
practical guide to the art and science of formulating drugs for
commercial manufacturing. With thoroughly revised and expanded
content, this third volume of a six-volume set, compiles data from
FDA and EMA new drug applications, patents and patent applications,
and other sources of generic and proprietary formulations including
author's own experience, to cover the broad spectrum of cGMP
formulations and issues in using these formulations in a commercial
setting. A must-have collection for pharmaceutical manufacturers,
educational institutions, and regulatory authorities, this is an
excellent platform for drug companies to benchmark their products
and for generic companies to formulate drugs coming off patent.
Features: Largest source of authoritative and practical
formulations, cGMP compliance guidance and self-audit suggestions
Differs from other publications on formulation science in that it
focuses on readily scalable commercial formulations that can be
adopted for cGMP manufacturing Tackles common difficulties in
formulating drugs and presents details on stability testing,
bioequivalence testing, and full compliance with drug product
safety elements Written by a well-recognized authority on drug and
dosage form development including biological drugs and alternative
medicines
The Handbook of Pharmaceutical Manufacturing Formulations, Third
Edition: Volume Two, Uncompressed Solid Products is an
authoritative and practical guide to the art and science of
formulating drugs for commercial manufacturing. With thoroughly
revised and expanded content, this second volume of a six-volume
set, compiles data from FDA and EMA new drug applications, patents
and patent applications, and other sources of generic and
proprietary formulations including author's own experience, to
cover the broad spectrum of cGMP formulations and issues in using
these formulations in a commercial setting. A must-have collection
for pharmaceutical manufacturers, educational institutions, and
regulatory authorities, this is an excellent platform for drug
companies to benchmark their products and for generic companies to
formulate drugs coming off patent. Features: Largest source of
authoritative and practical formulations, cGMP compliance guidance
and self-audit suggestions Differs from other publications on
formulation science in that it focuses on readily scalable
commercial formulations that can be adopted for cGMP manufacturing
Tackles common difficulties in formulating drugs and presents
details on stability testing, bioequivalence testing, and full
compliance with drug product safety elements Written by a
well-recognized authority on drug and dosage form development
including biological drugs and alternative medicines
The Handbook of Pharmaceutical Manufacturing Formulations, Third
Edition: Volume One, Compressed Solid Products is an authoritative
and practical guide to the art and science of formulating drugs for
commercial manufacturing. With thoroughly revised and expanded
content, this first volume of a six-volume set, compiles data from
FDA new drug applications, patent applications, and other sources
of generic and proprietary formulations to cover the broad spectrum
of GMP formulations and issues in using these formulations in a
commercial setting. A must-have collection for pharmaceutical
manufacturers, educational institutions, and regulatory
authorities, this is an excellent platform for drug companies to
benchmark their products and for generic companies to formulate
drugs coming off patent.
Preformulation studies are the physical, chemical, and biological
studies needed to characterize a drug substance for enabling the
proper design of a drug product, whereas the effectiveness of a
drug product is determined during the formulation studies phase.
Though the two disciplines overlap in practice, each is a
significantly distinct phase of new drug development. Entirely
focused on preformulation principles, this fully revised and
updated Handbook of Preformulation: Chemical, Biological, and
Botanical Drugs, Second Edition provides detailed descriptions of
preformulation methodologies, gives a state-of-the-art description
of each technique, and lists the currently available tools useful
in providing a comprehensive characterization of a new drug entity.
Features: Addresses the preformulation studies of three different
types of new active entities - chemical, biological, and botanical,
which is the latest established class of active ingredient
classified by the FDA Illustrates the activities comprised in
preformulation studies and establishes a method of tasking for drug
development projects Includes extensive flow charts for
characterization decision making Gives extensive theoretical
treatment of principles important for testing dissolution,
solubility, stability, and solid state characterization Includes
over 50% new material
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