Section 9.4 (Part 1)

9.4   Evaluation of new fresh frozen plasma/cryoprecipitate components for transfusion

Introduction

In establishing any novel component, the development process is expected to involve three stages:

Investigation: initial intensive investigation of a range of parameters on a relatively small number of units (e.g. 10) to establish concepts. This should involve in vitro studies with serial sampling, and may also involve in vivo studies. Components produced during this phase should not be used for transfusion

Validation: operational validation on a larger number of units (e.g. 50 to 100) to establish routine operation of the technique, normally testing for those parameters listed in the current edition of the 'Red Book'. These tests may be supplemented by a limited set of assays selected from the investigational phase to allow setting of routine quality parameters. This may involve in vivo studies and normally would involve sampling at the times shown below for routine testing

Table 9.4 Evaluation of new platelet components for transfusion

Parameter	PRP or BC (single donation)	Pooled PRP or BC or apheresis	Leuco-depletion	Pathogen reduction	Extended storage	Sterile connection	New bag, additive or anticoagulant
Volume (d1)
Platelet content
Leucocyte content (d1)	?	?		?	?		?
Leucocyte subsets (%)	?	?	?	?	?		?
Morphology, e.g. Swirl test
Activation, e.g. B thromboglobulin
Lysis, e.g. Lactate dehydrogenase
Metabolic activity, eg. ATP, pH
Function e.g. Aggregation	?	?	?	?	?	?	?
Side-Effects
Cytokines/chemokines	?	?
Complement activation	?	?	?	?	?
FXIIa			?	?			?
Sterility	?		if dock on				?
PrPc and microvesicles			?
Pathogen reduction*			?

Key: = recommended. ? = optional; other tests are not excluded. * = normally undertaken by the manufacturer. Planned studies may fall into more than one category in which case all indicated assays should be performed. d1 = day 1.

Routine: ongoing routine validation using a small set of parameters selected on the basis of the above studies. This will not normally involve in vivo studies. For clarity the guidance on which tests need to be performed is as shown in Table 9.4.

Currently, FFP for direct use or as start material for cryoprecipitate production is produced either from whole blood donations or by centrifugal apheresis techniques. Novel technologies under assessment include Amotosalen and Riboflavin pathogen reduction techniques. Apheresis techniques involving filtration have been approved in the past.