![]() ![]() These proteins are extracted from the serum and purified, then cleaved to separate the fragment that binds to the antigen (known as the fragment antigen-binding, or Fab) from the Fc, or fragment crystallizable region. To produce antibodies, animals are immunized with an antigen to produce a range of antibodies specific to that antigen. The company is scheduled to discuss the development pathway with the FDA and EMA in the coming months, which will determine the overall development timeline. SERB will conduct studies to assess the efficacy and safety of the product with initial results expected by the end of 2022. SERB has been a long-standing partner of health authorities, militaries, and other governmental and non-governmental agencies in the US, Europe, Latin America, the Middle East, and North Africa. Their current portfolio includes 14 critical care medicines that counter Chemical, Biological, Radiological, and Nuclear (CBRN) risks. SERB is an expert and leader in the field of medical countermeasures to protect the public and military forces. “Our expertise in antibody development and the commercial scale manufacturing capabilities acquired with BTG together with SERB’s track record of reliably providing a portfolio of high quality CBRN antidotes, uniquely position us to successfully deliver a solution.” “With no current therapeutic options, the threat of ricin represents a significant unmet need in the field of biodefense and medical countermeasures,” said Anthony Higham, CEO of SERB Pharmaceuticals. The modifications have removed the biological activity of the protein so that it is not toxic, while still retaining its shape to trigger an effective antibody response. The antibodies will be generated using a modified form of the ricin toxin, developed by Soligenix. This platform is currently used to manufacture two of the company’s currently marketed products, CroFab® and DigiFab®. This specialized manufacturing process generates binding fragments from antibodies that are specific to a given antigen, helping to ensure potency and purity. To develop the ricin antidote, SERB will leverage its unique broad spectrum polyclonal antibody platform, gained in its acquisition of BTG Specialty Pharmaceuticals. There is an unmet need for protection against this highly potent toxin for which there is no vaccine or therapeutic intervention available. Philadelphia, J(GLOBE NEWSWIRE) - SERB Pharmaceuticals has signed a worldwide exclusive license to use an antigen from Soligenix to develop a novel therapeutic treatment for ricin poisoning. ![]()
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