Process for lyophilising a product
Assignee4D Pharma LeóN S.L.U.
InventorsChristophe Carite, Sophie Declomesnil
Life of this patent
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Abstract
The present invention relates to a process for lyophilising a product (3), comprising the steps of providing a bulk product (3) loading system in the form of a bag (1), the bag (1) having an interior and an exterior defined by a flexible wall, the bag (1) further comprising a filling port (5) providing access to the interior of the bag (1), filling a product (3) having a first moisture content into the interior of the bag (1) via the filling port (5), and exposing the product (3) in the interior of the bag (1) to a lyophilisation cycle such that the moisture content of the product (3) is reduced from the first moisture content to a second, lower, moisture content.
Claims20
A method of lyophilizing a product comprising:
- a. filling a product into an interior of a bag, wherein the product comprises pharmaceutical-grade live anaerobic bacterial cells having a first moisture content;
- and
- b. exposing the product to a lyophilization cycle in a lyophilizer via a portion of the bag which is open, wherein the first moisture content of the product is reduced to a second moisture content,
- wherein the bag has an evaporative capacity of:
- (i) at least about 0.8×10−4 kg/s/m2 when measured at −10° C. and at 150 μbars;
- (ii) at least about 0.7×10−4 kg/s/m2 when measured at −10° C. and at 60 μbars;
- (iii) at least about 1.5×10−4 kg/s/m2 when measured at 0° C. and at 150 μbars;
- or
- (iv) at least about 1.0×10−4 kg/s/m2 when measured at 0° C. and at 60 μbars.
A method of lyophilizing a product comprising:
- a. filling a product into an interior of a bag, wherein the product comprises pharmaceutical-grade live anaerobic bacterial cells having a first moisture content;
- and
- b. exposing the product to a lyophilization cycle in a lyophilizer via a portion of the bag which is open, wherein the first moisture content of the product is reduced to a second moisture content,
- wherein the bag has a global heat transfer coefficient (Kv) of:
- (i) at least about 0.007 when measured at −10° C. and at 60 μbars or 150 μbars;
- (ii) at least about 0.01 when measured at 0° C. and at 150 μbars;
- or
- (iii) at least about 0.008 when measured at 0° C. and at 60 μbars.
Dependencies are inferred from the claim text.