Biomedical Engineering Reference
In-Depth Information
Table 1.3 Selected engineered biopharmaceutical types/products that have now gained marketing
approval. These and additional such products will be discussed in detail in subsequent chapters
Product description/type
Alteration introduced
Rationale
Faster acting insulins (Chapter 11)
Modifi ed amino acid sequence
Generation of faster acting insulin
Slow acting insulins (Chapter 11)
Modifi ed amino acid sequence
Generation of slow acting insulin
Modifi ed tissue plasminogen
activator (tPA; Chapter 12)
Removal of three of the fi ve
native domains of tPA
Generation of a faster acting
thrombolytic (clot degrading)
agent
Modifi ed blood factor VIII
(Chapter 12)
Deletion of 1 domain of native
factor VIII
Production of a lower molecular
mass product
Chimaeric/humanized antibodies
(Chapter 13)
Replacement of most/virtually
all of the murine amino acid
sequences with sequences
found in human antibodies
Greatly reduced/eliminated
immunogenicity. Ability
to activate human effector
functions
'Ontak', a fusion protein (Chapter 9)
Fusion protein consisting of the
diphtheria toxin linked to
interleukin-2 (IL-2)
Targets toxin selectively to cells
expressing an IL-2 receptor
the late 1970s and early 1980s. The bulk of these companies were founded in the USA, with
smaller numbers of start-ups emanating from Europe and other world regions.
Many of these fl edgling companies were founded by academics/technical experts who sought to
take commercial advantage of developments in the biotechnological arena. These companies were
largely fi nanced by speculative monies attracted by the hype associated with the establishment of the
modern biotech era. Although most of these early companies displayed signifi cant technical expertise,
the vast majority lacked experience in the practicalities of the drug development process (Chapter 4).
Most of the well-established large pharmaceutical companies, on the other hand, were slow to invest
heavily in biotech research and development. However, as the actual and potential therapeutic signifi -
cance of biopharmaceuticals became evident, many of these companies did diversify into this area.
Most either purchased small, established biopharmaceutical concerns or formed strategic alliances
with them. An example was the long-term alliance formed by Genentech (see later) and the well-
Table 1.4 Pharmaceutical companies who manufacture and/or market
biopharmaceutical products approved for general medical use in the USA
and EU
Sanofi -Aventis
Hoechst AG
Bayer
Wyeth
Novo Nordisk
Genzyme
Isis Pharmaceuticals
Abbott
Genentech
Roche
Centocor
Novartis
Boehringer Manheim
Serono
Galenus Manheim
Organon
Eli Lilly
Amgen
Ortho Biotech
GlaxoSmithKline
Schering Plough
Cytogen
Hoffman-la-Roche
Immunomedics
Chiron
Biogen
 
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