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The rise of bio- and nano-technology in the last decades has led to
the emergence of a new and unique type of medicine known as
non-biological complex drugs (NBCDs). This book illustrates the
challenges associated with NBCD development, as well as the
complexity of assessing the effects of manufacturing changes on
innovator and follow-on batches of NBCDs. It also touches upon
proven marketing authorization requirements for biosimilars that
could be effective in evaluating follow-on NBCDs, including a
demonstration of control over the manufacturing process and a need
for detailed physico-chemical characterization and (pre)clinical
tests. This book is meant to be used for years to come as a
standard reference work for the development of NBCDs. Moreover,
this book aims to stimulate discussions and further our thinking to
ensure that decisions regarding the approval of complex drugs are
made with relevant scientific data on the table.
This introductory text explains both the basic science and the
applications of biotechnology-derived pharmaceuticals, with special
emphasis on their clinical use. It serves as a complete one-stop
source for undergraduate/graduate pharmacists, pharmaceutical
science students, and for those in the pharmaceutical industry. The
Fourth Edition will completely update the previous edition, and
will also include additional coverage on the newer approaches such
as oligonucleotides, siRNA, gene therapy and nanotech.
The rise of bio- and nano-technology in the last decades has led to
the emergence of a new and unique type of medicine known as
non-biological complex drugs (NBCDs). This book illustrates the
challenges associated with NBCD development, as well as the
complexity of assessing the effects of manufacturing changes on
innovator and follow-on batches of NBCDs. It also touches upon
proven marketing authorization requirements for biosimilars that
could be effective in evaluating follow-on NBCDs, including a
demonstration of control over the manufacturing process and a need
for detailed physico-chemical characterization and (pre)clinical
tests. This book is meant to be used for years to come as a
standard reference work for the development of NBCDs. Moreover,
this book aims to stimulate discussions and further our thinking to
ensure that decisions regarding the approval of complex drugs are
made with relevant scientific data on the table.
Proteins are still gaining importance in the pharmaceutical world,
where they are used to improve our arsenal of therapeutic drugs and
vaccines and as diagnostic tools. Proteins are different from
"traditional" low-molecular-weight drugs. As a group, they exhibit
a number of biopharmaceutical and formulation problems. These
problems have drawn considerable interest from both industrial and
aca demic environments, forcing pharmaceutical scientists to
explore a domain previ ously examined only by peptide and protein
chemists. Biopharmaceutical aspects of proteins, e.g., low oral
bioavailability, have been extensively investigated. Although all
possible conventional routes of ad ministration have been examined
for proteins, no real, generally applicable alter native to
parenteral administration in order to achieve systemic effects has
yet been discovered. Several of these biopharmaceutical options
have been discussed in Volume 4 of this series, Biological Barriers
to Protein Delivery. Proteins are composed of many amino acids,
several of which are notorious for their chemical instability.
Rational design of formulations that optimize the native structure
and/or bioactivity of a protein is therefore of great importance
when long shelf life is required, as it is for pharmaceutical
products. This issue has also been examined in two prior volumes of
this series: Volume 2: Stability of Protein Pharmaceuticals (Part
A) and Volume 5: Stability and Characterization of Protein and
Peptide Drugs.
This book contains a selection of the papers presented at the
meeting "Between Clone and Clinic" which was organised in March
1990 in Amsterdam by the dutch Organisation for Applied Research,
TNO, and the University of Utrecht. The scope of this meeting was
the development of biotechnological pharmaceuticals mainly made by
recombinant DNA technology or monoclonal antibody techniques. All
aspects concerning the development of the products after host cells
producing them are obtained where discussed. The meeting was
attended by twohundred specialists from all over the globe,
including phar macologists, toxicologists, registration experts,
Quality Assurence managers, production en gineers and physicians.
Biotechnological pharmaceuticals are in general large and complex
protein molecules. Bringing these products to the market poses
other problems than encountered with the classical chemical drugs.
The source of biotechnological pharmaceuticals are living cells.
The function of cells are depend ent on many factors and the
stability of production may be a problem. Good Laboratory and
Manufactory Practices with Quality Control (GLP and GMP) are of
paramount importance and are discussed in a number of papers. The
products of the new biotechnology are often highly specific and
only active in the human species. Also the side effects can only be
studied in the clinical setting. Even when the product is active in
animals there is the problem of antigenicity. During treatment the
animals will produce antibodies which neutralise the activity. So
safety testing may prove difficult."
Proteins are still gaining importance in the pharmaceutical world,
where they are used to improve our arsenal of therapeutic drugs and
vaccines and as diagnostic tools. Proteins are different from
"traditional" low-molecular-weight drugs. As a group, they exhibit
a number of biopharmaceutical and formulation problems. These
problems have drawn considerable interest from both industrial and
aca demic environments, forcing pharmaceutical scientists to
explore a domain previ ously examined only by peptide and protein
chemists. Biopharmaceutical aspects of proteins, e.g., low oral
bioavailability, have been extensively investigated. Although all
possible conventional routes of ad ministration have been examined
for proteins, no real, generally applicable alter native to
parenteral administration in order to achieve systemic effects has
yet been discovered. Several of these biopharmaceutical options
have been discussed in Volume 4 of this series, Biological Barriers
to Protein Delivery. Proteins are composed of many amino acids,
several of which are notorious for their chemical instability.
Rational design of formulations that optimize the native structure
and/or bioactivity of a protein is therefore of great importance
when long shelf life is required, as it is for pharmaceutical
products. This issue has also been examined in two prior volumes of
this series: Volume 2: Stability of Protein Pharmaceuticals (Part
A) and Volume 5: Stability and Characterization of Protein and
Peptide Drugs."
Completely revised text that reflects to emergent trends and
cutting-edge advances in pharmaceutical biotechnology, this Third
Edition provides a well-balanced framework for understanding every
major aspect of pharmaceutical biotechnology, including drug
development, production, dosage forms, administration, and
therapeutic developments. New chapters cover evolving areas
regarding biopharmaceuticals, including oligonucleotides, siRNA and
various monoclonal antibodies, immunogenicity, gene therapy, and
the regulatory issues factoring into the biopharmaceutical approval
process
This introductory text explains both the basic science and the
applications of biotechnology-derived pharmaceuticals, with special
emphasis on their clinical use. It serves as a complete one-stop
source for undergraduate/graduate pharmacists, pharmaceutical
science students, and for those in the pharmaceutical industry. The
Fifth Edition completely updates the previous edition, and also
includes additional coverage on the newer approaches such as
oligonucleotides, siRNA, gene therapy and nanotech and enzyme
replacement therapy.
This introductory text explains both the basic science, production,
quality, dosage forms, administration, economic and regulatory
aspects and the clinical applications of biotechnology-derived
pharmaceuticals. It serves as a complete one-stop source for
undergraduate/graduate pharmacists and pharmaceutical science
students. An additional important audience are pharmaceutical
scientists in industry and academia, particularly those who have
not received formal training in pharmaceutical biotechnology and
are inexperienced in this field. The rapid growth and advances in
the field made it necessary to revise this textbook in order to
continue providing up-to-date information and introduce readers to
cutting edge knowledge and technology of this field. This Sixth
Edition completely updates the previous edition and includes
additional coverage on new approaches such as oligonucleotides,
siRNA, mRNA, gene therapy, cell therapies, monoclonal antibodies
and vaccines. With more than 3-million-chapter downloads, the fifth
edition of the textbook has achieved widespread distribution as a
key educational resource for the field of pharmaceutical
biotechnology.Â
This introductory text explains both the basic science and the
applications of biotechnology-derived pharmaceuticals, with special
emphasis on their clinical use. It serves as a complete one-stop
source for undergraduate/graduate pharmacists, pharmaceutical
science students, and for those in the pharmaceutical industry The
Fourth Edition will completely update the previous edition, and
will also include additional coverage on the newer approaches such
as oligonucleotides, siRNA, gene therapy and nanotech.
Completely revised text that reflects to emergent trends and
cutting-edge advances in pharmaceutical biotechnology, this Third
Edition provides a well-balanced framework for understanding every
major aspect of pharmaceutical biotechnology, including drug
development, production, dosage forms, administration, and
therapeutic developments. New chapters cover evolving areas
regarding biopharmaceuticals, including oligonucleotides, siRNA and
various monoclonal antibodies, immunogenicity, gene therapy, and
the regulatory issues factoring into the biopharmaceutical approval
process
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