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Novel Approaches and Strategies for Biologics, Vaccines and Cancer
Therapies takes a look at the current strategies, successes and
challenges involved with the development of novel formulations of
biologics, vaccines and cancer therapy. This thorough reference on
the latest trends in the development of diverse modalities will
appeal to a broad community of scientists, students and clinicians.
Written by leading authors across academia and industry, this book
covers important topics such as unique drug delivery devices,
non-parenteral delivery trends, novel approaches to the treatment
of cancer, immunotherapy and more. It includes real-world cases and
examples which highlight formulations with therapeutic proteins,
monoclonal antibodies, peptides and biobetters, as well as cases on
novel vaccines formulations including evolving pathogens, novel
modalities of vaccines, universal vaccines. This book is a thorough
and useful resource on the development of novel biologics, vaccines
and cancer therapies.
Mahatma Gandhi's humane philosophy and inherent spirituality had a
profound influence not only on the people of India but the freedom
loving people worldwide. 11th of September 2006 marked the
centenary of the Satyagraha movement launched by Mahatma Gandhi in
South Africa for peaceful resistance against discriminatory and
unjust laws. ""Satyagraha - the firmness of the force Truth""
became a powerful mass movement of peaceful resistance and civil
disobedience. Over the years, it evolved into a dynamic mass
movement of effective action.Commemorating 100 years of
'Satyagraha' in a befitting manner, the Indian National Congress
convened a two day international conference: ""Peace, Non-violence
and Empowerment: Gandhian Philosophy in the 21st Century"". Over
300 international delegates from 91 countries comprising world
leaders, Nobel laureates, leading peace and human rights activists
and Gandhian scholars reflected on the essence and the enduring
relevance of Mahatma Gandhi's philosophy. The conference
deliberated on subjects and issues which represent the core of
Gandhian thought. The discussion touched upon a wide range of
Gandhian principles and values including Mahatma Gandhi's concern
for the poor and his abiding commitment to non-violence and
people's empowerment. Emerging from the discussions amongst the
luminaries was the collective affirmation to renew people's
commitment to Mahatma's noble mission of building a world that is
in peace and harmony with itself.Based on the deliberations of this
conference, together with precious archival material, this volume -
a book for the future - endeavours to reach out and connect the
people, especially the younger generation, to the 'Gandhian way'
and to carry forward his legacy into the 21st century.
This book provides a detailed account of the most recent
developments, challenges and solutions to seamlessly advance and
launch a lyophilized biologics or vaccine product, based on diverse
modalities, ranging from antibodies (e.g., monoclonal, fused),
complex biologics (e.g., antibody drug conjugate, PEGylated
proteins), and vaccines (e.g., recombinant-protein based). The
authors adeptly guide the reader through all crucial aspects, from
biophysical and chemical stability considerations of proteins,
analytical methods, advances in controlled ice nucleation and
quality-by-design approaches, alternate drying technology, to
latest regulatory, packaging and technology transfer considerations
to develop a stable, safe and effective therapeutic protein,
vaccine and biotechnology products. Lyophilized Biologics and
Vaccines: Modality-Based Approaches is composed of four sections
with a total of 17 chapters. It serves as a reference to all
critical assessments and steps from early pre-formulation stages to
product launch: Provides recent understanding of heterogeneity of
protein environment and selection of appropriate buffer for
stabilization of lyophilized formulations Details the latest
developments in instrumental analysis and controlled ice nucleation
technology Explains in-depth lyophilized (or dehydrated)
formulation strategies considering diverse modalities of biologics
and vaccines, including plasmid DNA and lipid-based therapeutics
Details an exhaustive update on quality-by-design and process
analytical technology approaches, illustrated superbly by case
studies and FDA perspective Provides the latest detailed account of
alternate drying technologies including spray drying, bulk
freeze-drying and crystallization, supported exceptionally by case
studies Provides a step-by-step guide through critical
considerations during process scale-up, technology transfer,
packaging and drug delivery device selection, for a successful
lyophilization process validation, regulatory submission and
product launch Chapters are written by one or more world-renowned
leading authorities from academia, industry or regulatory agencies,
whose expertise cover lyophilization of the diverse modalities of
biopharmaceuticals. Their contributions are based on the exhaustive
review of literature coupled with excellent hands-on experiences in
laboratory or GMP setup, making this an exceptional guide to all
stages of lyophilized or dehydrated product development.
This book provides a detailed account of the most recent
developments, challenges and solutions to seamlessly advance and
launch a lyophilized biologics or vaccine product, based on diverse
modalities, ranging from antibodies (e.g., monoclonal, fused),
complex biologics (e.g., antibody drug conjugate, PEGylated
proteins), and vaccines (e.g., recombinant-protein based). The
authors adeptly guide the reader through all crucial aspects, from
biophysical and chemical stability considerations of proteins,
analytical methods, advances in controlled ice nucleation and
quality-by-design approaches, alternate drying technology, to
latest regulatory, packaging and technology transfer considerations
to develop a stable, safe and effective therapeutic protein,
vaccine and biotechnology products. Lyophilized Biologics and
Vaccines: Modality-Based Approaches is composed of four sections
with a total of 17 chapters. It serves as a reference to all
critical assessments and steps from early pre-formulation stages to
product launch: Provides recent understanding of heterogeneity of
protein environment and selection of appropriate buffer for
stabilization of lyophilized formulations Details the latest
developments in instrumental analysis and controlled ice nucleation
technology Explains in-depth lyophilized (or dehydrated)
formulation strategies considering diverse modalities of biologics
and vaccines, including plasmid DNA and lipid-based therapeutics
Details an exhaustive update on quality-by-design and process
analytical technology approaches, illustrated superbly by case
studies and FDA perspective Provides the latest detailed account of
alternate drying technologies including spray drying, bulk
freeze-drying and crystallization, supported exceptionally by case
studies Provides a step-by-step guide through critical
considerations during process scale-up, technology transfer,
packaging and drug delivery device selection, for a successful
lyophilization process validation, regulatory submission and
product launch Chapters are written by one or more world-renowned
leading authorities from academia, industry or regulatory agencies,
whose expertise cover lyophilization of the diverse modalities of
biopharmaceuticals. Their contributions are based on the exhaustive
review of literature coupled with excellent hands-on experiences in
laboratory or GMP setup, making this an exceptional guide to all
stages of lyophilized or dehydrated product development.
Development of new-generation vaccines is now more challenging than
ever, as identifying, purifying and evaluating vaccine antigens is
a complex undertaking. Most importantly, once the relevant antigens
have been identified, key focus then shifts to the development of
suitable delivery systems and formulations to achieve maximum in
vivo potency with minimum potential side effects. These novel
formulations-many of which will be nanoparticulates-can deliver the
antigens to the desired site, to the relevant antigen presenting
cells, and prevent systemic exposure of the immune potentiators.
The proposed book will outline all the critical steps that need to
be considered for successful development of various types of
nanoparticulate delivery systems for vaccine antigens. These
contributions from leading experts in the area of vaccine
formulation and delivery systems will tie in what is the most
current status, including clinical evaluations with these novel
vaccine technologies.
Development of new-generation vaccines is now more challenging than
ever, as identifying, purifying and evaluating vaccine antigens is
a complex undertaking. Most importantly, once the relevant antigens
have been identified, key focus then shifts to the development of
suitable delivery systems and formulations to achieve maximum in
vivo potency with minimum potential side effects. These novel
formulations-many of which will be nanoparticulates-can deliver the
antigens to the desired site, to the relevant antigen presenting
cells, and prevent systemic exposure of the immune potentiators.
The proposed book will outline all the critical steps that need to
be considered for successful development of various types of
nanoparticulate delivery systems for vaccine antigens. These
contributions from leading experts in the area of vaccine
formulation and delivery systems will tie in what is the most
current status, including clinical evaluations with these novel
vaccine technologies.
"Post Conflict Humanitarian Impact," is a case study of the
emergency healthcare provided by Medecines Sans Frontieres in Karbi
Anglong district of Assam in India. The author has evaluated the
perceptions of MSF's intervention by the stakeholders of the
conflict and to assess the achievement of MSFis project with
respect to its planned objectives, as well as determining
effectiveness of the implementation process.In 2005 ethnic conflict
erupted between two tribes (Dimasa & Karbi) with a history of
centuries of amicable coexistence. Militants from both the tribes
indulged in killing of innocent people. The population fled to
towns for protection. 50 relief camps were established to provide
shelter and care to about 50,000 Internally Displaced Persons. MSF
work has saved hundreds of lives with preventive and curative
action. MSF worked fearlessly providing humanitarian service
without discrimination of caste, creed, religion, community and
region. However, a section of the population viewed the work of MSF
with suspicion of having hidden agenda behind the relief work.The
author has made some recommendations which would be pertinent to
the humanitarian interventions.
Development of numerical methods to solve partial differential
equations is extremely important as most of the real life physical
systems can be formulated in the form of these. By solving partial
differential equations, the characteristics of a physical system
can be simulated even without performing laboratory experiments.
This book discusses the development of few efficient numerical
tools to solve diffusion and wave equation. Methods for treating
diffusion of atoms, molecules, ions and charge carriers in solid
state and optoelectronic structures are presented. Additionally,
split-step based numerical method for bi-directional wave
propagation is presented. This method requires only matrix
multiplications at each step and no inversion or diagonalization is
required.The numerical tools presented in the book are applied to
analyze numerous diffusion and wave propagation based processes.
The current relationship between India and the United Kingdom and
what the growing partnership holds for the future of the two
nations--and consequently the rest of the world--is the focus of
this study that combines original essays from more than three dozen
thought leaders in the worlds of academia, business, politics, and
the arts. The book assesses the potential for the two countries to
forge an enhanced partnership and surveys the main features of a
diverse and complex bilateral relationship. The essays analyze the
scope for a new partnership that recognizes the role the UK can
play in India's quest for international stature. Also included are
a foreword by Indian Prime Minister Manmohan Singh and a chapter by
British Prime Minister David Cameron.
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