Status: formerly used as an intermediate

Organizations involved:

Baxter Hyland Immuno – Manuf.; R&D; Tech.

Baxter Healthcare Corp. – Parent

Cross ref: See the entry (#781) above for Respiratory Syncytial Virus Immune Globulin (Human) or RespiGam, and the entry for a recombinant respiratory syncytial virus (RSV) monoclonal antibody (Synagis) (#245).

Description: RSV High Titer Fraction II+III Paste (For Further Manufacturing Use) is an immune globulin concentrate fractionated from pooled fractionated blood Plasma obtained from donors having high levels of respiratory syncytial virus (RSV) antibodies (from prior exposure to the virus).

This product is approved only as an intermediate for further manufacture. The use(s) for this intermediate product are unstated in available documentation. This product has been used by an undisclosed (redacted/censored from FDA documents) manufacturer as raw material for further manufacture of an unspecified product(s). This product might have been used for manufacture of RSV immune globulin (RespiGam) by the Massachusetts Biological Labs. (although the text blocks deleted in FDA documents indicate an organization with a much shorter name), formerly marketed by MedImmune, Inc. It may be used for manufacture of RSV diagnostics.

The dating period when stored at 2-20˚C (frozen) is 12 months from the date of manufacture, defined as the date of plasma teardown.

Nomenclature: RSV Immune Globulin, conc. [BIO]; RSV High Titer Fraction II+III Paste (For Further Manufacturing Use) [FDA]; Respiratory Syncytial Virus Immune Globulin, concentrate [SY]

Companies.: This intermediate product is manufactured by Baxter Healthcare Corp. (Glendale, CA), FDA CBER est. lic. no. 0140. The company (or companies) using this product for further manufacture are unknown.

FDA class: Biologic PLA

CBER class: Blood And Blood Derivatives

Approvals: Date = 19960910; first approval, PLA

Indications: product insert/labeling is not available

Status: The product was approved only as an intermediate/precursor for further manufacture of unspecified product(s). RSV High Titer Fraction II+III Paste (For Further Manufacturing Use) was exempt from FDA CBER lot release requirements.

Approval was apparently voluntarily revoked, with the product no longer appearing in CBER/FDA list of approved products, but is now listed again. With CBER/FDA no reporting.