Chicago CMO opens potent small molecule site

By Fiona BARRY contact

- Last updated on GMT

Regis Technologies will offer an HPAPI service
Regis Technologies will offer an HPAPI service

Related tags: Pharmacology, Manufacturing

Contract manufacturing organisation Regis Technologies has added an HPAPI (highly potent active pharmaceutical ingredient) service.

The Chicago-based company will manufacture materials for small molecule oncology drugs, and linkers and payloads for antibody drug conjugates. A Potent Compound Suite will allow cGMP manufacturing up to 1kg per batch.

HPAPI production requires specialised facilities to minimise contamination risks. The site is equipped withisolators, laminar flow hoods and local exhaust ventilation.

The facility has a containment performance target (CPT) set to 50 ng/m3, based on the occupational exposure limits (OELs) of the specific APIs to be manufactured there.

Regis already operates a 36,000 sq ft cGMP facility in Morton Grove, Illinois. As well as cGMP API manufacturing, it performs chiral separations, scale-up, and commercial manufacturing. ​ 

Related news

Show more

Related products

show more

Integrated Solutions for Accelerated Time to Market

Integrated Solutions for Accelerated Time to Market

Piramal Pharma Solutions | 08-Jun-2021 | Technical / White Paper

Facing capacity constraints? Lock in your program now! With 14 sites around the world providing diverse services ranging from discovery to drug substance...

Innovations in OSD

Innovations in OSD

Recorded the 06-Oct-2020 | Webinar

This DFE series of educational webinars looks at innovations in Oral Solid Dose Forms with the emergence of advanced technologies such as Continuous Manufacturing...

Related suppliers

Follow us

Products

View more

Webinars