Raw materials suit molecular diagnostics manufacturing

SAFC, which we reported last week had a manufacturing suite in its St. Louis facility certified in the safe handling of potent APIs, has entered the molecular diagnostics market by providing regulatory-compliant and custom-manufactured raw materials.

The new line combines four product groups, the company says: molecular-grade raw materials tested on key contaminants, Proligo Reagents raw materials, molecular products for polymerase chain reaction and other applications, and custom synthesized oligonucleotides. Primary growth areas in the market, according to the company, include blood bank testing; infectious disease testing; cancer identification, susceptibility and therapy monitoring; pharmacogenics; and gene/chromosome testing.

The raw materials suit both traditional in vitro diagnostics manufacturers working in molecular diagnostics and dedicated molecular diagnostics companies. Products are produced in ISO 9001 facilities, the company says.

Separately, IVAX Diagnostics subsidiary Diamedix has amended its distribution agreement with IMMCO Diagnostics, a provider of autoimmune diagnostic services, giving Diamedix rights to distribute IMMCO products in the U.S. The deal also provides Diamedix with strategic initiatives related to the U.S. and Canadian markets.

- see the SAFC release
- here's our potent API handling coverage
- and here's the Diamedix release

Suggested Articles

Teva will produce its new migraine drug at a plant in Israel and more news of note.

The shortage of childhood cancer drug vincristine was front and center during the Senate hearing for Stephen Hahn, nominee for FDA commissioner.

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.