GMP News - Blood / Biologics and ATMP

05.12.13

FDA: Draft Guidance for Industry: Donor Testing for Evidence of Infection with Treponema pallidum (Syphilis)

With the Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis), the FDA provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. Read more.

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05.12.13

FDA Science and Research: Keeping stored platelets free of bacteria

Scientists at the US Food and Drug Administration (FDA) have demonstrated in animal studies a proof-of-concept approach that might reduce the bacterial burden of room temperature stored human platelets. For more details read here.

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05.12.13

Recommendations for Premarket Notification Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation

Most cells of the body bear human leukocyte antigens which allow the human immune system to distinguish the body’s own blood, organs and tissues from foreign substances. Related to test kits for these HLA, the FDA published a Draft Guidance with recommendations for premarket notification submissions. Read more here.

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19.09.13

World Health Organisation (WHO) continues successful collaboration with Paul-Ehrlich-Institut

WHO and PEI - eight years of successful cooperation for Quality Assurance of Blood Products and in vitro Diagnostic Devices. Read more here.

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19.09.13

EMA Guideline on Quality of biological active Substances produced by transgene Expression in Animals

In May, the Committee for Medicinal Products for Human Use (CHMP) adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. Read more.

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19.09.13

Draft Guidance with Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products

Referring to the increasing need of Cellular and Gene Therapy products, the FDA published a daft guideline "Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products". More details can be found here.

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27.08.13

EMA Guideline Guideline on the use of bovine serum in the manufacture of human biological medicinal products

The EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products will come into effect at the end of 2013. Read more here.

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27.08.13

FDA publishes Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility

Computer validation will be an important topic for blood establishments too. The US FDA published a guideline on that topic in March 2013. Read more here.

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27.08.13

FDA Scientists link transfused UVB irradiated platelets with acute lung injury

Scientists at the U.S. Food and Drug Administration (FDA) have reported that studies performed in animals provide a proof of a concept that transfused UV-light damaged PLTs can mediate lung injury. Read more.

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11.07.13

Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

Related to changes to an approved application of human blood and blood components intended for transfusion or further manufacture, the FDA published a draft guidance for comment. Read more here.

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11.07.13

FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products.

The US FDA has conducted retrospective analyses of data from a large health claims-related database as well as continued postmarketing adverse event reports of thrombosis. These analyses have strengthened the evidence for an association between the use of intravenous, subcutaneous, and intramuscular human immune globulin products and the risk of thrombosis. For that reason the authority now demands a boxed warning for the entire class of products. Read more.

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21.03.13

Safety of Blood Components for Transfusion and of Stem Cell Products: Testing for HIV, HBV and HCV

In February, the Paul-Ehrlich-Institut published a  notification on "Imposition of conditions pursuant to Section 28 (3) c AMG (Arzneimittelgesetz, German Medicines Act) for the purpose of risk prevention to assure the safety of blood components for transfusion and of stem cell products for haematopoetic reconstitution: Testing for HIV, HBV and HCV". Read more.

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21.03.13

FDA Recommendations for Syphilis Screening of Blood and Blood Components

In March 2013, the FDA published a draft guidance "Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis". For more details read here.

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21.03.13

Technical Update of Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors

The FDA updated the ongoing Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 of the Compliance Program Guidance Manual. Get more details.

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18.02.13

Starting Materials and Intermediates

In the European pharmaceutical legislation, requirements are outlined for particulars and documents that should accompany an application for marketing authorisation of a biological medicinal product. This includes information related to starting and raw materials. The draft reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products i supposed to provide information on that topic. Read more here.

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