The BLA is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2), and is regulated under 21 CFR 600–680. A BLA is submitted by any legal person or entity who is engaged in manufacture, or an applicant for a license who takes responsibility for compliance with product and establishment standards.
WHEATON and Irvine Scientific have collaborated to introduce a high yield, small-scale solution for bioproduction. This solution consists of a WHEATON® CELLine™ bioreactor flask paired with Irvine Scientific’s BalanCD™ CHO Growth A animal component-free, chemically-defined medium. Now, small-scale antibody and protein production can be quickly set up and performed while decreasing the cost per milligram produced.
WHEATON CELLine Bioreactors separate cells from the bulk growth medium by a dialysis membrane that regulates the flow of nutrients and waste products to and from the cell chamber. The lower side of the cell chamber is made of a gas permeable membrane allowing continuous exchange of oxygen and carbon dioxide.
Irvine Scientific's BalanCD CHO Growth A medium, in combination with the CELLine bioreactor, yields antibody levels higher than conventional methods without the use of a mechanical shaker or agitation.
This bundled product is now available through WHEATON and its extensive distributor network.
For more information, please visit WHEATON.com, email CELLine@WHEATON.com, or call 800.225.1437 (USA)/856.825.1100 (International).
Norovirus Monoclonal Antibodies
ViroStat has released two new sets of MONOTOPE™ monoclonal antibodies to the major capsid protein of the GI and GII noroviruses. These new antibodies function in ELISA and lateral flow applications for rapid detection of these viruses. Noroviruses are single-stranded RNA viruses that possess a non-enveloped protein capsid. Norovirus is the leading cause of food-borne illness in the United States.