Method for detecting infectious parvovirus in pharmaceutical preparations

1. A method for producing a pharmaceutical product containing a pancreatic enzyme preparation having a porcine parvovirus (PPV) viral load below a threshold level comprising:

a. obtaining a sample from a pancreatic enzyme preparation;

b. detecting the load of porcine parvovirus in the sample comprising:

i. extracting the sample at least two times with chloroform prior to precipitation producing a clarified sample with an upper phase and a lower phase;

ii. precipitating an aliquot of the upper phase from step i) with polyethylene glycol (PEG);

iii. suspending the product from step ii) in a buffer;

iv. precipitating the product from step iii) with PEG;

v. suspending the product from step iv) in an aqueous solution;

vi. optionally extracting the product from step v) with chloroform producing a clarified sample with an upper phase and a lower phase; the upper phase forming a purified solution; and

vii. determining the load of porcine parvovirus in the solution; and

c. producing a pharmaceutical product with the remainder of the pancreatic enzyme preparation if the porcine parvovirus viral load measured in step b) is below a fluorescence focus infectious dose (FFID 50 ) PPV viral load of about 10 5 FFID 50 .

2. The method of claim 1 , wherein the PEG is PEG 8000.

3. The method of claim 1 , wherein the pancreatic enzyme composition is pancrelipase or pancreatine comprising various ratios of at least three enzymes selected from the group consisting of lipase, amylase, and protease.