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Global peptide partnership
LOUISVILLE, Ky.—Peptides International and Peptisyntha have entered into a global partnership for the production of research-grade peptide active pharmaceutical ingredients (APIs). Customers will benefit from access to the combined research and manufacturing expertise of the two companies, as well as seamless transition from research level through commercial manufacturing, saving customers time and cost from peptide candidate screening through preclinical and clinical development. The collaboration will be facilitated by a technology transfer internal agreement.
Peptides International can produce 36 peptides in a four-to-five day period, depending on length and sequence, running its automated small-scale synthesizer around the clock.
"This makes us competitive with Asian outfits," says PI President and Chief Operating Officer Dr. Michael Pennington.
In addition, Pennington notes, the company has custom peptide synthesis expertise across a wide range of technologies, from multi-disulfide peptides to multistep organic synthesis. PI also offers an extensive portfolio of building blocks and other peptide synthesis tools, and its activities have recently been certified to ISO 9001:2008 standards.
With 25 years of experience in peptide manufacturing, Peptisyntha, a wholly owned company of Solvay, provides a seamless portfolio of expertise from lead optimization to commercial cGMP manufacturing. Peptisyntha has developed and demonstrated expertise in the design of cost-effective peptide manufacturing processes and in the cGMP production of clinical and commercial peptide APIs. Its facilities have had numerous successful U.S. Food and Drug Administration and European Medicines Agency inspections and offer a full range of solid-phase (SPPS), liquid-phase (LPPS) and hybrid synthesis capabilities. With GMP manufacturing facilities in the United States and Belgium, Peptisyntha supports all manufacturing technologies (SPPS, LPPS and hybrid approaches) at all scales.
One reason for heightened interest in peptide chemistry is the challenge posed by the problem of drug delivery through the cell membrane in order to treat and manage diseases and conditions as diverse as HIV and constipation. The discovery of cell-penetrating peptides (CPPs) represented a major breakthrough for the transport of large-cargo molecules that may be useful in clinical applications. CPPs are able to translocate over membranes and gain access to the cell interior, delivering large-cargo molecules, such as oligonucleotides, into cells.
Pennington cites a number of sulfide-bearing peptides, many of which are derived from venom. Fuzeon (Enfuvirtide injection) is a 39-residue peptide used in combination with other drugs to treat HIV infection in people who have not responded well enough to other antiviral medications. Enfuvirtide is in a class of medications called HIV fusion inhibitors. It works by stopping HIV from infecting healthy cells.
Because chemotherapy has unwanted side effects and kills healthy tissue around the tumor, researchers have long been interested in developing alternative forms of therapy. The aim of targeted therapies, as the name implies, is to target cancerous cells while leaving surrounding cells unaffected.
One type of targeted therapy that looks promising against glioblastoma is based on the venom of the yellow Israeli scorpion, Leiurus quinquestriatus. The venom is among the most toxic of all scorpion venoms; it contains histamine, enzymes, enzyme inhibitors and the potent neurotoxins chlorotoxin and charbydotoxin, which specifically target low-conductance glioma-chloride chloride channels (GCC) and high-conductance calcium-gated potassium channels, respectively.
Byetta is derived from gila monster venom, Pennington notes, and is approved to treat type 2 diabetes, both by itself and in combination with certain oral diabetes medications. Byetta comes in an injection form and works by increasing insulin production after meals and decreasing the amount of sugar produced by the liver. As a result, Byetta can help lower blood sugar levels, which can decrease the risks of developing long-term problems associated with diabetes, including heart disease.
Finally, Linaclotide is a 15-residue peptide with three disulfide units that can be given orally to relieve constipation, while SHK is a potassium channel blocker derived from sea anemone toxin that is entering clinical trials for multiple sclerosis and is a candidate for preventing transplant rejection and in the treatment of other autoimmune diseases.