MARCH 1–EAST HILLS, N.Y.–By using an advanced purification technology from Pall Corporation (NYSE: PLL) the Thai Red Cross Society has significantly increased production and purity of Equine Antirabies Immunoglobulins (ERIG) used to cure rabies in humans.
Post exposure treatment of rabies with antirabies immunoglobulins is still very important in order to reduce deaths in Thailand. Many companies in Europe have stopped production of equine rabies immunoglobulins and products are in short supply to hospitals. Pall’s automated ultrafiltration technology reduces the time it takes to purify immunoglobulins from one week to one day, while increasing yield levels. The new technology enables Thailand to supply these critical ERIG to the Centers for Disease Control in Thailand for the first time.
Pall’s purification technology was part of a $4.5 million modernization of the Queen Saovabha Memorial Institute (QSMI), the manufacturing facility of the Thai Red Cross. The modernization makes the Institute the first GMP-compliant biologics facility in Thailand, and it recently received GMP certification from the Thai Food and Drug Administration.
A presentation on how this new technology is used to accelerate purification of Equine Rabies Immunoglobulins was given at the Scientific Meeting on Progress in Rabies Research and Control in Bangkok last month by John Westbrook, Pall Corporation’s Managing Director in Thailand. The meeting was part of a celebration to honor the 80th anniversary of the QSMI, and the 48th birthday of Crown Princess Maha Chakri Sirindorn, who is Vice President of the Thai Red Cross Society.
“Pall engineered an innovative purification process that will enable the Thai Red Cross to produce and distribute over 100,000 doses of Equine Rabies Immunoglobulins per year, in addition to other critical medicines,” reports Westbrook. “This reinforces Thailand’s leadership position in biological manufacturing in Southeast Asia.”
In addition to Equine Rabies Immunoglobulins and snake antivenoms for poisonous snake bites, the QSMI produces BCG (a tuberculosis vaccine) and tuberculin solutions used for TB skin tests.
“The QSMI has produced snake antivenoms since 1923, BCG vaccines started in 1953 and incorporating this new processing technology in snake antivenoms builds upon the Thai Red Cross’s reputation and expertise in this area,” says Professor Sumana Khomvilai, Deputy Director of the QSMI.
Pall’s purification technology uses specific filtration media to separate undesirable proteins from the immunoglobulin (IgG) complex used to make both equine rabies and antivenoms immunoglobulins. The centerpiece of the Institute’s modernization is the incorporation of Pall’s CENTRASETTE; 5 (C5) Tangential Flow Filtration (TFF) system. It replaces the dialysis bags and tubing that were used to remove contaminants from the immunoglobulins. The C5 system is automated and significantly accelerates removal of unwanted proteins and salts. The system is fully compliant with GAMP and cGMP guidelines and enables the QSMI to achieve higher purity levels.
In addition to the CENTRASETTE TFF system, Pall Seitzschenk; K-200 composite filter media is used for initial clarification. Sterile filtration of buffer is accomplished with 10-inch Ultipor; N66 filter cartridges that can be steam sterilized in place (SIP) up to 15 times. All air in the facility is filtered with Novasip; cartridges and product assurance is maintained with Palltronic FlowStar filter integrity test equipment.
Equine anti-rabies and snake antivenom immunoglobulins are produced by immunizing horses with low concentrations of rabies vaccines and snake venoms. The antibodies produced in the blood of these horses are then purified and further sterile filtered according to GMP serum production.
John Westbrook’s lecture, “Purification of Rabies Immunoglobulin,” was presented at the Scientific Meeting on Rabies, at the Tawana Ramada Hotel, Surawongse Road, Bangkok.