Plasma Protein Therapeutics Assoc

“The association will have the following divisions of membership: global membership - available to organizations engaged in the manufacture of therapies in more than one continent. Regional membership - available to organizations engaged in the manufacture of therapies from a particular geographic area. Plasma membership - available to organizations engaged in collecting and processing plasma for further manufacturing. Associate membership - organizations or groups of organizations providing services to organizations that qualify for either global, regional or plasma membership in the association.”

“Membership applications all applications for membership in the association must be made in writing to the association and must be approved by the relevant board. The membership application must contain sufficient information to demonstrate compliance with the appropriate eligibility requirements. Each membership application must also be supported by a letter of recommendation, which shall describe the applicant's ethical and commercial good standing in the plasma protein therapies industry, from at least two members of the relevant board. Membership approval requires an affirmative vote of at least two-thirds (2/3) of the members of the relevant board. The global executive board shall not act on any manufacturer application for regional membership in the association until the applicable regional board has made an affirmative recommendation.”

“Management reviewed the form 990 prior to filing.”

“On an annual basis, all officers, directors, key employees, and highest compensated employees are provided a copy of the association's written conflict of interest policy, and are asked to review it as a reminder that all conflicts of interest are to be reported to an officer of the association as soon as possible after the discovery of a potential conflict of interest so that safeguards can be established to protect all parties.”

“The process for determining the compensation for the ceo & president is during an executive session of the board of directors, the board discussed the general salary and benefit levels of people in similar positions. Surveys and general personal experience of the board were used in deciding the compensation package of the ceo & president. For the top management staff, gene stroshane, ppta vp finance & operations, reviews a report of the compensation, including bonuses, with the compensation committee of the board (chairman and treasurer). They discuss the salary levels of the staff and review for reasonableness based on experience with the functions within their own organization as well as personal experience in other non-profit boards that they are a part of.”

“No documents made available to the public”

“Form 990, part i, doing business as: ppta”

“As a trusted partner to health systems, ppta drives broad and reliable access to high-quality plasma protein therapies, with a focus on the well- being of patients and plasma donors. The plasma protein therapeutics association (ppta) represents a unique sector of the biologics and biotechnology industry. Ppta represents more than 1,000 human plasma collection centers in north america and europe, as well as the manufacturers of lifesaving plasma protein therapies. Our members produce approximately 80% of the plasma protein therapies in the u.s. And 60% of those manufactured in europe. Ppta works globally to advocate for patient access to plasma-derived medicines, responsibly improve the availability of plasma, and advance the understanding of the plasma ecosystem: -promote clinician authority and patient participation in treatment decisions -pursue reimbursement models recognizing the unique nature of plasma protein therapies -shape decisions of authorities to improve plasma protein therapy availability -forage partnerships that support patient-focused initiatives -advocate for global sufficiency of plasma -pioneer plasma safety and manufacturing quality and support donor well- being -drive progressive policies for plasma collections -encourage plasma donation, globally -generate and promote evidence-based information about plasma -explain the importance, unique nature, and value of plasma protein therapies plasma and plasma collection: plasma is the clear, straw-colored liquid portion of blood that remains after red blood cells, white blood cells, platelets and other cellular components are removed. It is the single largest component of human blood, comprising about 55 percent, and contains water, salts, enzymes, antibodies and other proteins. -composed of 90% water, plasma is a transporting medium for cells and a variety of substances vital to the human body. -plasma carries out a variety of functions in the body, including clotting blood, fighting diseases and other critical functions. -source plasma is plasma that is collected from healthy, voluntary donors through a process called plasmapheresis and is used exclusively for further manufacturing into final therapies (fractionation). Source plasma donors may be compensated for their time and effort. -recovered plasma is collected through whole blood donation in which plasma is separated from its cellular components. Recovered plasma may be used for fractionation. Source plasma is collected through a process called plasmapheresis. In more than 1,000 specialized donation centers located in the u.s. And europe, individuals may donate plasma. Plasmapheresis is a sterile, self-contained, automated process that separates plasma from red blood cells and other cellular components which are then returned to the donor. Source plasma collection in the u.s. Is regulated by the u.s. Food and drug administration (fda) and, in europe, by the european medicines agency (ema) and national regulatory authorities. Plasma manufacturing: source and recovered plasma is the starting material used to manufacture lifesaving therapies. The manufacturing process is known as fractionation. Proteins are separated through this process to create numerous plasma protein therapies. This process is carried out using well-established purification methods such as precipitation, centrifugation, separation, and filtration. Plasma is pooled and processed through a process called "fractionation" that employs time, temperature, ph, and alcohol concentrations to extract specific therapeutic proteins. These are then subjected to various purification methods and viral inactivation and removal processes to further ensure their safety and efficacy. Preparing a therapy often takes from 7-12 months between donation and final product release. This sets the production of plasma protein therapies apart from chemical pharmaceuticals and other biologics whose manufacturing processes are much more condensed and whose direct manu”

“The north america data program is a voluntary manufacturer initiative undertaken in response to drug shortage concerns, and is intended to provide a reliable, nation-wide assessment of the availability of these life-saving therapies in the united states. Ppta's web-based system provides aggregate, monthly distribution data for the following categories of plasma protein therapies: 1. Albumin 5% 2. Albumin 25% 3. Immune globulin (ig) 4. Plasma-derived factor viii 5. Recombinant factor viii”

“The audit oversight process has remained unchanged from the prior year.”