Antibody Tool Box for Infectious Diseases

We are well aware of the current development efforts for human/humanized monoclonal antibodies as therapeutic treatments. But what about the other pharma ,applications that monoclonal and polyclonal antibodies can provide, especially regarding infectious diseases? Here are just a few examples:

Anti-Infectives New treatments are actively being developed for agents such as Hepatitis B, Hepatitis C, HIV and tuberculosis. Monoclonal antibodies contribute a vital role as critical assay components to assess the effectiveness of drug candidates for these agents. What kinds of assays are employed? Cell based assays are particularly attractive as they more closely approximate the in-vivo state. They also allow for high volume throughput screening of drug candidate libraries.
A typical assay is designed as follows. Genetic constructs of permissive cells are created to carry and express the viral sequences of interest (target). These adherent cells are grown in multi-well plates. At time point(s) during the viral expression phase candidate drugs (+ controls) are added. To assess which drugs have inhibited (downregluated) the target, specific monoclonal antibody to the target is added. Effective penetration of the antibody into the cells may require prior fixation/permeabilization treatments. Second antibody conjugate is then applied allowing for an eventual colorimetric, fluorescence or chemiluminescence readout. Specific examples of such an assay would include the HCV targets: core, NS3 protease, NS3 helicase, NS4a, NS4b, NS5a & NS5b polymerase. ViroStat produces monoclonal antibodies to all of these HCV specificities for use in just such assays.

Vaccine Development/Manufacture Renewed interest is now being focused on the development of new vaccines against agents including Influenza virus, Vaccinia virus, Anthrax, Tuberculosis & Malaria among others. Some are pandemic threats or biodefense threats while others are centuries old scourges of mankind. Some of these agents are viral while others are bacterial or parasitic. The recent success story of the effectiveness and licensure of the vaccine against human papillomavirus in preventing cervical cancer has done much to bolster economic optimism for a market that was considered mature and low margin.

Polyclonal antibody from hyperimmunized animals can often serve as a model for protective (human) immune serum during vaccine development. Such reagents often demonstrate the requisite viral neutralization (Vaccinia), bactericidal (Vibrio cholera) or toxin neutralization (diphtheria) characteristics required. They can be the starting point for teasing apart those antigen specificities that are critical for immune protection.

Monoclonal antibodies which exhibit viral neutralization (Respiratory Syncytial Virus) can likewise identify critical antigen targets as candidate vaccines, but go a step further by defining the exact epitope(s) involved. Thus opening the possibilities for constructing peptide arrays, peptide scaffolds or peptide conjugates as candidate vaccines.

Finally, once a vaccine has been developed, approved and marketed it must be manufactured on a consistent potency/quality basis. Animal based monoclonal and polyclonal antibodies can form the cornerstone of in-house assays to monitor and ensure that in-process as well as final release criteria are met. The typical assay for this purpose is a sandwich ELISA employing 2 antibodies; one unlabeled (capture), the other labeled with a reporter molecule (conjugate). Such assays can be amplified if necessary for measuring low level analytes (such as contaminants) or de-sensitized when measuring higher level (finished) proteins. ViroStat offers many of its viral and bacterial antibodies already HRP conjugated as well as unconjugated for developing just such ELISA assays.

ViroStat is a primary manufacturer of infectious disease antigens and antibodies, supplying researchers and manufacturers since 1985. Specialties include high affinity antibodies to Flu A, Flu B, RSV & Adenovirus for use in rapid lateral flow devices as well as antibodies to food-borne pathogens and toxins. Also, many specificities to HCV, HBV, CMV & EBV for use in anti-viral HTS assays. A vast collection of monoclonal antibodies to a variety of bacteria, viruses, parasites and toxins is available. These MONOTOPE™ mouse monoclonal antibodies come already purified as ready made tools for your assay development. Please visit us @ www.virostat-inc.com.