GMP News - Blood / Biologics and ATMP

17.02.20

Final Guideline on GCP for ATMPs published

The European Commission has now published the final Guideline GCP for ATMP as a further building block of its growing guidance package on  the requirements for Advanced Therapy Medicinal Products.

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06.11.19

General requirements for Plastics in Pharmaceutical Engineering

The main material used in plant engineering is stainless steel. The variant 316L is regarded as standard; material incompatibilities of steel with the product play almost no role. This is different for plastics. Beside the leach-out, ageing and surface finishing, other quality features are often specified. Now, what are the general requirements for plastics in pharmaceutical plant engineering?

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16.10.19

Japanese Pharmacopoeia - Draft Chapter of alternative Endotoxin Testing

The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.

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08.10.19

Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

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08.10.19

FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis

In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers".

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08.10.19

ATMP from Third Countries - New Q&A Paper on Batch Release published

With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

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07.08.19

FDA's promotion for cell and tissue products - the TRG Rapid Inquiry Program (TRIP)

With an additional program to support manufacturers of cells, tissues and cell-based products, the FDA is trying to accelerate its promotion of the development of regenerative therapies.

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17.07.19

Do liquid, sterile medicinal products have to be particle-free?

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

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09.07.19

FDA keeps an eye on use and marketing of cell and tissue products

The FDA publishes an Untitled Letter to a manufacturer of stem cell products that are used to treat various diseases and are not expected to meet regulatory requirements.

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09.07.19

ATMPs in combination with a medical device - QP task on release

With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.

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09.07.19

How to handle possibly lifesaving OOS batches of ATMP - A question that concerns manufacturers and authorities

In the context of a Q&A document, the European Medicines Agency (EMA) offers assistance and information on when an Advanced Therapy Medicinal Product (ATMP) can be approved for treatment even in the case of an out-of-specification batch.

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09.07.19

Transmission of multiresistant microorganisms during transplantation

Following incidents involving the transmission of multi-resistant germs during the use of faecel microorganisms for transplantation, the FDA has established additional measures to minimise the risk of transmission.

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25.04.19

FDA issues Warning Letter to Manufacturer of Human Cells, Tissue or Cell based Products

The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.

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25.04.19

FDA publishes Inspection Report for Cells, Tissues and Cell Products

The US FDA published its regular inspection report on Human Cell, Tissue and Cell based Products (HCT/Ps), which also includes current data from 2018.

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03.04.19

ICH M10 - Draft Guideline on Validation of Bioanalytical Methods published for public Comments

On 13 March, the Euroepan Medicines Agency (EMA) published a the draft ICH Guideline M10 on bioanalytical method validation for public comments.

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