|
Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
|
Buy Now
Handbook of Biogeneric Therapeutic Proteins - Regulatory, Manufacturing, Testing, and Patent Issues (Paperback)
Loot Price: R1,977
Discovery Miles 19 770
|
|
|
Handbook of Biogeneric Therapeutic Proteins - Regulatory, Manufacturing, Testing, and Patent Issues (Paperback)
Expected to ship within 12 - 19 working days
|
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
General
Is the information for this product incomplete, wrong or inappropriate?
Let us know about it.
Does this product have an incorrect or missing image?
Send us a new image.
Is this product missing categories?
Add more categories.
Review This Product
No reviews yet - be the first to create one!
|
You might also like..
|
Welcome to Loot.co.za!
Sign in / Register |Wishlists & Gift Vouchers |Help | Advanced search
