Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain
the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in
Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles
and JavaScript.
In responding to future influenza pandemics and other infectious agents, plasmid DNA overcomes many of the limitations of conventional vaccine production approaches.
Most monoclonal antibodies in clinical trials are owned by small biotech companies. But with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change.
At the end of next month, the European Medicines Agency (EMEA) will implement a new legislative framework and several provisions that seek to provide incentives and streamline regulatory oversight of certain monoclonal antibodies and other biologic products.
Ensuring adequate manufacturing capacity for recombinant and monoclonal antibodies is one of the greatest challenges facing the biotech industry. The following factors should be taken into account when designing product development and production strategies.
The failure of many bio-ontologies to follow international standards for ontology design and description is hampering their application and threatens to restrict their future use.
The current generation of antibodies has done more than make a few companies rich. It has laid the groundwork for ambitious companies to move to maturity.
Mexico's genomic researchers believe a mestizo “hapmap” might reveal a genetic basis for some of the nation's health problems, although they are mindful of the potential for the misuse of personal genetic information.
While the FDA waits for someone to come up with a plan to improve the accelerated approval program, some argue that as it is, drugs are not getting to the people who need them.
The Indian biotechnology industry is trying to get beyond being a service industry, but the cost of materials and of getting regulatory approval could confound such efforts.
As new drug approval rates drop in Europe compared to the US, the EU Commission plans to spur innovation by doubling financial support for the biotech industry.
Seizing upon a favorable business climate in Europe, US businesswoman Lisa Drakeman has blended goal-oriented American culture with a European focus on team effort to move her firm's antibodies closer to the market.
Industry hopes to build on recent successes of monoclonal antibodies in oncology and inflammatory disease. But evidence is mounting that the exquisite selectivity and binding capacity of these therapeutics can have unwanted side effects, particularly in autoimmune disease. Christopher Thomas Scott investigates.
