FDA-regulated BPL Plasma centers, for example, utilize the International Quality Plasma Program (IQPP), a third-party evaluation system that ensures the source plasma is collected with utmost care. IQPP-approved plasma is exclusively intended to create life-saving plasma protein therapies. Regulation of plasma for fractionation in the United States. Plasma for fractionation (PF) to make plasma derived medicinal products is in high demand, particularly in middle- and low-income countries. Regulation of plasma for fractionation in the United States. In 1991, PPTA initiated the International Quality Plasma Program (IQPP) that.
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ANNAPOLIS, Md., Oct. 9, 2017 /PRNewswire/ - The fifth annual will be celebrated October 8-14. A joint initiative of the (PPTA) and its, IPAW is designed to:.
Raise global awareness about source plasma collection. Recognize the generous contributions of plasma donors in saving and improving lives. Increase understanding about lifesaving plasma protein therapies and rare diseasesPlasma is the straw-colored liquid portion of blood comprised of water, salts, and proteins. These proteins are necessary for carrying out critical functions in the human body, such as antibodies to fight diseases and clotting factors to regulate bleeding. If a person has insufficient levels of any one plasma protein, his or her body cannot carry out these vital functions, causing a variety of chronic and life-threatening medical conditions.Plasma is used to create lifesaving therapies to treat chronic, life-threatening diseases including bleeding disorders, hereditary angioedema, chronic inflammatory demyelinating polyneuropathy, primary immune deficiencies, alpha-1 antitrypsin deficiency, and certain rare neurological disorders. In addition, these therapies are used in emergency and surgical medicine.Plasma protein therapies are made from human plasma which can only be obtained from healthy, qualified donors who generously give their time to donate.
Plasma donors are the foundation of the plasma protein therapeutics industry. Healthy and committed donors are paramount for preparing safe and effective therapies; plasma protein therapies would not exist without the generosity of donors in the U.S., Canada, Germany, Austria, the Czech Republic, and Hungary. In addition to meeting regulatory requirements, the majority of plasma donation centers have achieved (IQPP) certification.
PPTA's voluntary standards program provides global leadership for the industry's goal of continuous improvement with a focus on safety and quality from the donor to the patient.' People throughout the world rely on plasma protein therapies which are developed through the generosity and commitment of plasma donors. PPTA is proud of the contributions we and our member companies make to saving and improving lives,' said Joshua Penrod, PPTA, Vice President, Source & International Affairs.PPTA member companies—which collectively operate more than 650 IQPP-certified facilities—are planning a variety of donor appreciation events during IPAW which helps remind donors of the immense contribution they make toward improving a patients' life.
In addition, representing individuals with rare diseases have pledged their support. A multi-language is available; use #IPAW2017 when sharing the materials to show your support.The Plasma Protein Therapeutics Association (PPTA), a global industry trade association, represents the private sector manufacturers of plasma-derived and recombinant analog therapies, collectively known as plasma protein therapies and the collectors of source plasma used for fractionation. These therapies are used by millions of people worldwide to treat a variety of diseases and serious medical conditions. PPTA also administers standards and programs that help ensure the quality and safety of plasma protein therapies, donors, and patients.
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Plasma and Plasma Protein TherapeuticsPlasma is the protein-rich fluid that suspends the cells in blood. It performs many important transport functions, and the proteins found in plasma play critical roles in clotting and providing immunity to diseases.When isolated from plasma through a complex manufacturing process, these proteins become important medical therapies.
Plasma proteins are used to treat many conditions including:. immune deficiencies. autoimmune disorders. neurological & bleeding disorders. shocks and burnsThe number of patients that require these therapies continues to grow rapidly.Learn more about our plasma proteins by visiting our section. Collecting PlasmaThe process of collecting plasma starts with the generosity of healthy volunteer donors. Plasma can be extracted in two ways: from whole blood donations (recovered plasma), or more commonly through specific plasma donation (source plasma).Source plasma donation is similar to a blood donation but it incorporates a process called plasmapheresis, where the cellular components of the blood (red blood cells, white blood cells and platelets) are separated from the plasma and returned to the donor, while the plasma is retained.
The plasmapheresis process is sterile, self-contained and automated. Donors provide the raw materials needed for life-saving and life-sustaining therapies.The collection of plasma in Canada is regulated by and by the in the United States. Plasma collection centers may also undergo additional certification in the voluntary International Quality Plasma Program that was developed by the Plasma Protein Therapeutics Association, an international trade and advocacy organization. These standards not only ensure the safety of the donors, but also that the plasma collected and used to manufacture drugs is of the highest possible quality.Manufacturing ProcessPlasma proteins are only a small component of plasma, which is made up mostly of water. This means it takes a lot of plasma to make therapeutics. Having an efficient process to manufacture plasma proteins is highly desirable.All commercial manufacturers currently serving the North American market extract plasma proteins using a process called “fractionation” that was developed in the 1940s and includes manufacturing steps using cold alcohol and salt and pH adjustments.We are developing an efficient new and proprietary chromatography process for manufacturing plasma proteins.
It has demonstrated high yields for existing therapies and provides for potential access to novel therapies of high quality and purity from the precious supply of plasma to address unmet patient demands. Therapure is currently manufacturing its lead therapy at clinical scale in preparation for in human trials in 2017.The manufacturing of these products is regulated by and by the in the United States. Additionally the Plasma Protein Therapeutics Association’s (PPTA’s) Quality Standards of Excellence, Assurance and Leadership program goes beyond the regulations to ensure highest quality and safety of the final products.
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