PLASMA PROTEIN THERAPEUTICS ASSOCIATION
147 OLD SOLOMONS ISLAND RD NO 100, ANNAPOLIS, MD 21401 www.pptaglobal.org

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Organizations Filed Purposes: THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION SERVES AS THE CORNERSTONE FOR CONSENSUS DEVELOPMENT OF INDUSTRY-WIDE INITIATIVES AND IS THE PRIMARY ADVOCATE FOR THE LEADING PRODUCERS OF PLASMA-BASED AND RELATED RECOMBINANT BIOLOGICAL THERAPEUTICS. THE ASSOCIATION'S MISSION IS TO PROMOTE AN ENVIRONMENT THAT FOSTERS THE AVAILABILITY OF SAFE AND EFFECTIVE PLASMA PROTEIN THERAPEUTICS. AS THE GLOBAL REPRESENTATIVE FOR THE PLASMA THERAPEUTICS INDUSTRY, THE ASSOCIATION WORKS COOPERATIVELY WITH PATIENT GROUPS, LEGISLATORS, REGULATORY AGENCIES AND OTHERS TO ADDRESS CRITICAL ISSUES THAT IMPACT THE INDUSTRY AND THOSE PEOPLE WHO DEPEND ON PLASMA PROTEIN THERAPEUTICS. THE ASSOCIATION'S GLOBAL COMMITTEES AND REGIONAL WORKING GROUPS BRING TOGETHER INDUSTRY EXPERTS TO FOCUS ON IMPORTANT ISSUES RELATING TO THE QUALITY, SAFETY AND EFFICACY OF PLASMA THERAPEUTICS.

PPTA ADVOCATES AND PROMOTES SAFE AND EFFECTIVE PLASMA PROTEIN THERAPEUTICS.

PPTA REPRESENTS THE INTERESTS OF THE PLASMA COLLECTION AND FRACTIONATION INDUSTRY WITH REGARD TO REGULATORY, LEGISLATIVE AND OTHER PUBLIC POLICY ISSUES. PPTA STAFF WORKS COOPERATIVELY WITH GOVERNMENTAL INSTITUTIONS AND REGULATORY AGENCIES THROUGHOUT THE WORLD. PPTA STAFF MONITOR REGULATORY AND POLICY ACTIVITIES (UNITED STATES CONGRESS, THE EUROPEAN COMMISSION, THE WORLD HEALTH ORGANIZATION, FDA, EMEA AND VARIOUS OTHER INTERNATIONAL AND NATIONAL REGULATORY AGENCIES AND COMMITTEES), COORDINATE INDUSTRY POSITIONS ON EXISTING, NEW AND EMERGING ISSUES, AND DEFINE AND DEVELOP STRATEGIC INITIATIVES THAT ENHANCE THE INDUSTRY'S REGULATORY ENVIRONMENT.PPTA SPEAKS WITH ONE VOICE ON ASSOCIATION AND MEMBER PROGRAMS AND INITIATIVES.PLASMA COLLECTION:PLASMAPHERESIS IS ONE OF THE MAIN WAYS TO OBTAIN PLASMA, ANOTHER TYPE OF PLASMA IS "RECOVERED PLASMA." THROUGH PLASMAPHERESIS, ONLY THE PLASMA IS COLLECTED AND THE BLOOD CELLS REMAIN IN THE DONOR. BLOOD DONORS LOSE PART OF THE OXYGEN-CARRYING CAPACITY OF THE BLOOD, WHICH IS RESTORED RELATIVELY SLOWLY. PLASMA DONORS ONLY LOSE THE PROTEINS IN PLASMA AND RETAIN THEIR CAPACITY FOR OXYGEN TRANSPORT. SINCE PLASMA PROTEINS ARE SYNTHESIZED MORE RAPIDLY THAN BLOOD CELLS, IT IS POSSIBLE TO COLLECT A LARGER VOLUME ON EACH OCCASION AND COLLECT FROM A DONOR MORE OFTEN. IN MOST CASES, BLOOD ESTABLISHMENTS HAVE ACQUIRED PLASMAPHERESIS EQUIPMENT AND DELIVER SOURCE PLASMA (APHERESIS PLASMA) DIRECTLY TO FRACTIONATORS.PLASMA COLLECTION CENTERS ARE REGULATED BY THE COUNTRY IN WHICH THEY ARE LOCATED, AS WELL AS THE COUNTRIES TO WHICH THEY MAY SUPPLY PLASMA FOR FURTHER MANUFACTURE. PLASMA COLLECTION IN THE US:MOST PLASMA CENTERS ARE LOCATED IN THE UNITED STATES AND THEREFORE, ARE LICENSED AND REGULATED BY THE FOOD & DRUG ADMINISTRATION (FDA). THESE PLASMA CENTERS ARE INSPECTED ON AN UNANNOUNCED BASIS AND MUST COMPLY WITH STRICT FDA REGULATIONS FOR DONOR SAFETY AND PRODUCT QUALITY. THEY MUST ALSO COMPLY WITH LABORATORY TESTING REGULATIONS UNDER THE US CLINICAL LABORATORY IMPROVEMENT ACT (CLIA) AND WORKER SAFETY REGULATIONS UNDER THE OCCUPATIONAL SAFETY AND HEALTH ACT (OSHA).VOLUNTARY STANDARDS:IN ADDITION TO GOVERNMENT-MANDATED REGULATIONS, THE PLASMA INDUSTRY ADHERES TO VOLUNTARY STANDARDS SET BY INDUSTRY, THE PPTA INTERNATIONAL QUALITY PLASMA PROGRAM (IQPP). THIS PROGRAM WAS ESTABLISHED BY PPTA SOURCE (FORMERLY ABRA) IN 1991. IQPP CERTIFICATION REFLECTS THE QUALITY OF A FACILITY'S DONORS AND THE PLASMA COLLECTED, THE PROFESSIONAL/MEDICAL OPERATION OF THE FACILITY AND A WELL-TRAINED STAFF. PPTA SOURCE ALSO DEVELOPED THE NATIONAL DONOR DEFERRAL REGISTRY (NDDR) IN THE US WHICH IS DESIGNED TO BE USED BY PLASMA CENTERS TO CHECK DONORS AGAINST A COMPUTERIZED LIST OF PERMANENTLY DEFERRED DONORS. THIS SYSTEM SERVES TO FURTHER ASSURE THE SAFETY OF PLASMA AND PLASMA PRODUCTS. PLASMA FRACTIONATION:ONCE THE SOURCE PLASMA IS COLLECTED, PPTA MEMBERS USE THE PLASMA TO PRODUCE LIFE-SAVING THERAPIES. THERAPIES INCLUDE ALBUMIN, USED AS A BLOOD VOLUME EXPANDER; COAGULATION THERAPEUTIES, USED IN THE TREATMENT OF VARIOUS BLEEDING DISORDERS; IMMUNE GLOBULIN THERAPEUTICS FOR INFECTIOUS DISEASE PREVENTION, AND ALPHA-1 PROTEINASE INHIBITOR, USED IN THE TREATMENT OF ALPHA-1 ANTITRYPSIN DEFICIENCY. THE ENVIRONMENTS IN WHICH THESE THERAPIES ARE MADE ARE TIGHTLY REGULATED. INTERNATIONALLY, THE EUROPEAN COMMISSION, THE COUNCIL OF EUROPE, THE WORLD HEALTH ORGANIZATION AND HEALTH AUTHORITIES WITHIN INDIVIDUAL NATIONS THROUGHOUT EUROPE AND THE PACIFIC RIM PARTICIPATE IN THE REGULATION OF THE INTERNATIONAL PLASMA DERIVATIVES INDUSTRY. IN THE UNITED STATES, THE FOOD AND DRUG ADMINISTRATION, THE NATIONAL INSTITUTES OF HEALTH, THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC), OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA), THE DEPARTMENT OF TRANSPORTATION, AND CONGRESS ALL MAINTAIN AND PRACTICE REGULATORY OVERSIGHT.IN ADDITION TO GOVERNMENT MANDATED REGULATIONS, PPTA MEMBERS ADHERE TO THE PPTA-DEVELOPED QUALITY, SAFETY, EXCELLENCE, ASSURANCE AND LEADERSHIP (QSEAL) PROGRAM. THIS PROGRAM, INITIATED IN 2000, COMPRISES A SET OF VOLUNTARY STANDARDS APPLICABLE TO MANUFACTURING FACILITIES. THE PROGRAM REQUIRES THE USE OF SOURCE PLASMA FROM QUALIFIED DONORS FROM CENTERS ADHERING TO PPTA'S VIRAL MARKER STANDARD, NUCLEIC ACID AMPLIFICATION TECHNOLOGY (NAT) TESTING FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV), HEPATITIS B (HBV), AND HEPATITIS C (HCV), PARVOVIRUS B19 NAT TESTING AND A 60-DAY INVENTORY HOLD. THE INVENTORY HOLD SERVES TO REDUCE THE PROBABILITY OF ANY WINDOW PERIOD DONATIONS FROM ENTERING THE MANUFACTURING POOL. HOLDING EACH DONATION FOR A PERIOD OF 60 DAYS PRIOR TO POOLING ALLOWS MANUFACTURERS TO PREVENT SPECIFIC UNITS FROM BEING POOLED IN CASES WHERE A DONOR SUBSEQUENTLY TESTS POSITIVE FOR A VIRAL MARKER DURING THE 60-DAY PERIOD. THESE STANDARDS, IN CONJUNCTION WITH STATE-OF-THE-ART TESTING TECHNOLOGIES AND VALIDATED VIRAL INACTIVATION METHODS, HAVE HAD A POSITIVE IMPACT ON THE SAFETY OF PLASMA THERAPEUTICS. TOGETHER, THE VOLUNTARY STANDARDS PROGRAMS FURTHER ENHANCE THE QUALITY AND SAFETY OF PLASMA THERAPEUTICS

FOUNDED IN 1994, PPTA EUROPE, FORMERLY THE EUROPEAN ASSOCIATION OF THE PLASMA PRODUCTS INDUSTRY (EAPPI), IS THE PRIMARY ADVOCATE FOR THE LEADING PRODUCERS OF PLASMA-BASED AND RELATED RECOMBINANT BIOLOGICAL THERAPEUTICS. THE ASSOCIATION, THROUGH ITS WORKING GROUPS, DEVELOPS INDUSTRY-WIDE CONSENSUS POSITIONS AND INITIATIVES.PPTA EUROPE ACTS AS THE PRINCIPLE INTERLOCUTOR WITH REGULATORY AUTHORITIES ON A NATIONAL AND EUROPEAN LEVEL AND WITH NATIONAL GOVERNMENTS. PPTA EUROPE IS COMMITTED TO BEING INVOLVED IN ALL DISCUSSIONS DIRECTLY RELEVANT TO THE PLASMA THERAPEUTICS INDUSTRY AND THE PATIENTS WHO DEPEND ON THE MEDICINES PRODUCED BY OUR MEMBERS.PPTA EUROPE WORKS CLOSELY WITH PPTA NORTH AMERICA TO BRING TOGETHER INDUSTRY EXPERTS FROM AROUND THE WORLD TO FOCUS ON IMPORTANT ISSUES RELATING TO THE QUALITY, SAFETY AND EFFICACY OF PLASMA THERAPEUTICS.

PATIENT NOTIFICATION SYSTEM:THE PATIENT NOTIFICATION SYSTEM IS A FREE, CONFIDENTIAL, 24-HOUR COMMUNICATION SYSTEM PROVIDING INFORMATION ON PLASMA-DERIVED AND RECOMBINANT PRODUCT WITHDRAWALS AND RECALLS IN NORTH AMERICA.THE SYSTEM WAS CREATED TO PROVIDE CONSUMERS WITH A SINGLE, CONVENIENT AND CONFIDENTIAL SOURCE FOR UP-TO-DATE PRODUCT WITHDRAWAL AND RECALL INFORMATION. LED BY THE PLASMA PROTEIN THERAPEUTICS ASSOCIATION (PPTA), THE PATIENT NOTIFICATION SYSTEM WAS DEVELOPED BY THE PRODUCERS AND DISTRIBUTORS OF PLASMA PRODUCTS WITH DIRECT INPUT FROM CONSUMERS.ORIGINALLY AVAILABLE IN THE US, IN 2002, THE SYSTEM EXTENDED TO CONSUMERS IN CANADA. IN EUROPE, IT IS THE RESPONSIBILITY OF THE NATIONAL GOVERNMENTS TO INFORM CONSUMERS ABOUT PRODUCT WITHDRAWAL AND RECALL INFORMATION. ON THIS BASIS PPTA EUROPE DOES NOT HAVE A PATIENT NOTIFICATION SYSTEM IN OPERATION.ENSURING CONFIDENTIALITY:MAINTAINING PATIENT CONFIDENTIALITY WAS ONE OF THE PRIMARY CONSIDERATIONS IN DEVELOPING THE SYSTEM. AN ADVISORY PANEL MADE UP OF REPRESENTATIVES FROM CONSUMER GROUPS HELPED DESIGN THE SYSTEM TO SAFEGUARD SENSITIVE PATIENT INFORMATION. TO ENSURE CONFIDENTIALITY, THE PATIENT NOTIFICATION SYSTEM IS OPERATED BY STERICYCLE, INC., AN INDEPENDENT ORGANIZATION THAT SPECIALIZES IN PHARMACEUTICAL NOTIFICATIONS.ALL PATIENT INFORMATION WILL BE HELD IN STRICT CONFIDENCE BY THE NATIONAL NOTIFICATION CENTER.FREE TO CONSUMERS:THERE IS NO FEE TO PARTICIPATE IN THE PATIENT NOTIFICATION SYSTEM. THE SYSTEM IS FUNDED BY THE PRODUCERS AND DISTRIBUTORS OF PLASMA-DERIVED AND RECOMBINANT PRODUCTS AND IS FREE TO CONSUMERS AND HEALTH CARE PROVIDERS.COOPERATIVE EFFORT BETWEEN INDUSTRY AND CONSUMERS:KEY CONSUMER GROUPS, INCLUDING ALPHA 1 ASSOCIATION, ALPHA ONE FOUNDATION, COMMITTEE OF TEN THOUSAND, HEMOPHILIA FEDERATION OF AMERICA, IMMUNE DEFICIENCY FOUNDATION AND NATIONAL HEMOPHILIA FOUNDATION, WORKED CLOSELY WITH THE PLASMA PROTEIN THERAPEUTICS INDUSTRY IN DESIGNING THE PATIENT NOTIFICATION SYSTEM. THE SYSTEM IS ADMINISTERED BY PPTA AND IS SUPPORTED AND FUNDED BY ALL MAJOR PLASMA-DERIVED AND RECOMBINANT MANUFACTURERS. A WORKING GROUP MADE UP OF STAKEHOLDERS AND INDUSTRY REPRESENTATIVES HAS BEEN FORMED TO PROVIDE INPUT ON THE SYSTEM AND MAKE ADDITIONAL RECOMMENDATIONS FOR FUTURE ENHANCEMENTS.HOW THE SYSTEM WORKS:FIRST, ANYONE INTERESTED IN PARTICIPATING REGISTERS WITH THE PATIENT NOTIFICATION SYSTEM AND PROVIDES GENERAL CONTACT INFORMATION, INCLUDING THEIR PREFERRED METHOD OF NOTIFICATION. PARTICIPANTS HAVE THE OPTION OF BEING NOTIFIED BY TELEPHONE, FAX, OR E-MAIL, WHICHEVER IS MOST CONVENIENT FOR THEM. IF A PRODUCT IS WITHDRAWN OR RECALLED, THE COMPANY INVOLVED IMMEDIATELY CONTACTS THE STERICYCLE, INC. WHO THEN NOTIFIES THE ENROLLED REGISTRANT DIRECTLY. EVERY EFFORT WILL BE MADE TO NOTIFY REGISTRANTS WITHIN 24 HOURS. THOSE REGISTRANTS WHO CHOOSE TO BE NOTIFIED BY TELEPHONE, FAX OR E-MAIL WILL ALSO RECEIVE A LETTER BY FIRST-CLASS MAIL TO ENSURE RECEIPT OF THE INFORMATION. IN ADDITION, CONSUMERS CAN CALL A 24-HOUR, TOLL-FREE NUMBER (1-888-UPDATE-U) FOR CURRENT INFORMATION ON PRODUCT RECALLS OR WITHDRAWALS. TO MAXIMIZE THE USEFULNESS OF THE SYSTEM, IT IS IMPORTANT FOR CONSUMERS TO KEEP ACCURATE INFUSION LOGS AND RECORD THE LOT NUMBER, PRODUCT NAME AND MANUFACTURER FOR ALL PLASMA PRODUCTS USED.HOW TO REGISTER:PARTICIPANTS CAN REGISTER ON LINE AT: WWW.PATIENTNOTIFICATIONSYSTEM.ORG OR BY CALLING 1-888-UPDATE-U.WORKING GROUPCONSUMER GROUPS:ALPHA 1 FOUNDATIONCOMMITTEE OF TEN THOUSANDFOOD AND DRUG ADMINISTRATION (FDA)GBS/CIDP FOUNDATION INTERNATIONALHEMOPHILIA FEDERATION OF AMERICAHEREDITARY ANGLOEDEMA ASSOCIATIONIMMUNE DEFICIENCY FOUNDATIONJEFFREY MODELL FOUNDATIONNATIONAL HEMOPHILIA FOUNDATIONPLATELET DISORDER PLASMA PRODUCT PRODUCERS AND DISTRIBUTORS:BAYER HEALTHCARE LLCBIOGEN INC.BIO PRODUCTS LABORATORY LTD.BIOTEST PHARMACEUTICALS CORPORATIONCSL BEHRING CANADAEMERGENT BIOSOLUTIONSGRIFOLS USA LLCKEDRION BIOPHARMACEUTICALSNOVO NORDISK, INC.OCTAPHARMA USA, INC.OCTAPHARMA CANADA, INC.PFIZER INCTAKEDASYSTEM ADMINISTRATOR:PLASMA PROTEIN THERAPEUTICS ASSOCIATION147 OLD SOLOMON'S ISLAND RD., STE. 100ANNAPOLIS MD 21401PHONE: (202) 789-3100FAX: (410) 263-2298WWW.PPTAGLOBAL.ORGSYSTEM OPERATOR:STERICYCLE2670 EXECUTIVE DRIVEINDIANAPOLIS, IN 46241PHONE: 1-888-UPDATE-UFAX: 1-800-442-2906WWW.PATIENTNOTIFICATIONSYSTEM.ORG

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