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Declaration 12 4.2017 relating to the experimental study of D07 (B1)

Declaration 23.11.2017 relating to an experimental study relating to example 3 of D2 (B1)

Declaration Piers Acland QC relating to experimental study relating to example 3 of D2 (B1)

EMA Guidelines: Notes for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses, 14 February 1996 (1996-02-14), (B1)

EP-A2- 0 934 748 (B1)

Exhibit 1: experimental study relating to example 3 of D2 (B1)

JOHNSTON ADCOCK;: Biotechnology and Genetic Engineering Reviews, vol. 17, 2000, (B1)

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Pharmacia LKB Biotechnology AB, 1991. Ion exchange chromatography principles and methods (3rd edition) Pharmacia, Uppsala, Sweden (B1)

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CAMERON et al.: "the removal of model viruses poliovirus type 1 and canine parvovirus", Biologicals, vol. 25, 1997, pages 391-401, (B1)