Regis Other Service | Cube County

Bioluminescent Reagents

Whether performing reporter gene assays, ELISA and HTS assays, ATP swabs, whole animal assays, or other imaging applications, choose Regis Technologies’ high purity D-Luciferin and Coelenterazine for a high quality product at an affordable price for in vitro and in vivo assays.

Advantages of Regis bioluminescent reagents include:

High signal and low noise, >99% Purity
Excellent reproducibility and sensitivity
Quality products, delivered in days from a trusted supplier

Our bioluminescent reagents are manufactured and tested in our FDA-inspected, GMP-certified facility for a minimum purity of 99% by HPLC and 99.5% enantiomeric purity by chiral HPLC analysis. Additional quality tests include water by titration, and identity by FTIR.

ATP Coelenterazine is commonly used for bioluminescent calcium detection and the monitoring of reporter genes in BRET, ELISA and HTS methods as well as chemiluminescent detection of superoxide anions and peroxynitrite in cells or tissues.

Coelenterazine-Native
Coelenterazine-H

High Potent API Manufacturing

Regis Technologies is announcing their entry into the oncology market with the start up of the new Potent Compound Suite (PCS). The PCS allows Regis, a Chicago-based contract manufacturing organization (CMO), to target small molecule oncologicals and linker payload projects for antibody drug conjugates. Regis is a CMO operating a 36,000 square foot, cGMP facility in Morton Grove, Illinois. The PCS addition provides for small molecule cGMP manufacturing of potent compounds up to about one kilogram per batch.

Regis’ Director of Business Development states “We see the PCS as an important asset to serve the growing oncology market as more companies look to advance their lead candidates into the clinic.” Regis’

Regis Technologies is announcing their entry into the oncology market with the start up of the new Potent Compound Suite (PCS). The PCS allows Regis, a Chicago-based contract manufacturing organization (CMO), to target small molecule oncologicals and linker payload projects for antibody drug conjugates. Regis is a CMO operating a 36,000 square foot, cGMP facility in Morton Grove, Illinois. The PCS addition provides for small molecule cGMP manufacturing of potent compounds up to about one kilogram per batch.

Regis’ Director of Business Development states “We see the PCS as an important asset to serve the growing oncology market as more companies look to advance their lead candidates into the clinic.” Regis’ Manager of Process Engineering, Dragan Ristic, supervised the design and construction of the suite. Proper handling of potent compounds requires the use of specialized facilities that are carefully designed to minimize containment risks. Regis’ new PCS includes isolators, laminar flow hoods and local exhaust ventilation appropriate for potent compound handling.

Regis worked with high containment industry consultants to choose the best laboratory and personal protective equipment for potent compound handling and conducted employee training. Regis also completed validations and cGMP qualifications for the suite. In 2015, the PCS passed the commissioning process. Safebridge Consultants, Inc. evaluated the containment performance of the facility via industrial hygiene monitoring. Based on the occupational exposure limits (OELs) of the future Active Pharmaceutical Ingredients (APIs) to be handled, a containment performance target (CPT) was set to 50 ng/m3.

The surrogate monitoring involved handling of surrogate material (naproxen sodium) in PCS by Regis’ employees, while performing the air and surface sampling by certified industrial hygienist in order to find out how much of material could escape from the containment.

The report described the testing methodology and provided an objective interpretation of the results indicating that the containment performance of the equipment is in full compliance with the Regis’ CPT. Personal and area measurements for surrogate powder handling showed that containment isolator system in the PCS1 can be used to handle a wide range of potent APIs.

The surface sampling results were found to be well below the performance-based acceptable surface limit (ASL) for SafeBridge Category 3 (Regis HHC 4) compounds. This evaluation gives further confidence that potent APIs are being handled safely at Regis Technologies, protecting employees, products, and environment.

Regis is excited to add the capabilities of the PCS to our 60 year long resume of supporting biotech and pharma customers. Founded in 1956, Regis has long been recognized as a premier partner for the clinical and commercial production of small molecule APIs. Its outstanding compliance history, technical and project management teams, and central US location have made it the supplier of choice for emerging and mid-size pharma. Please visit www.registech.com for more information.

Wet Milling - Micronization

Regis is a full-service custom small molecule API manufacturer with an excellent quality record that

offers many complementary support services including analytical development, solid state chemistry,

and impurity identification, characterization, and fate & purge studies. Our newest service is in particle

size reduction. Regis now offers wet (slurry) milling services.

Wet Milling can readily achieve particle sizes similar to jet milling (10-20 microns)
Advantages of Wet Milling vs. Jet Milling
- Does not require special containment for SafeBridge 3+ compound handling (materials are slurried in a liquid)
- Ideal choice for sensitive materials, as liquid dissipates heat from the mill
  - Little chance for form change during micronization, which can happen with jet milling
- Little or no yield loss (material loss from Jet Milling can typically be 10-20%)
- No need for separate lab and production units
  - Same unit handles lab and production runs
  - Straightforward correlation between lab and production particle sizes
- Wet Milling is a minor operation that is added to the final processing step where the slurry (API/solvent) is run through the wet mill followed by the final filtration and drying. The operation is built into the master batch record, has little/no yield loss, and no separate containment is required outside of normal operations.

Fate and Purge

Drug substances produced by chemical syntheses contain impurities (organic, inorganic, elemental,

or residual solvents) which must be controlled in order to ensure the desired product quality. The various

Regulatory Authorities require that impurities above a certain threshold be identified and tracked, and

that all mutagenic and genotoxic impurities be reported at any level. Critical Quality Attributes (CQA) of

the drug substance and all isolated intermediates need to be identified, justified, and included in the

specifications. Generation and depletion of impurities which are formed during chemical syntheses or

due to limited stability of intermediates should be investigated in a “fate and purge” study.

Services include:

Identify and Justify Critical Quality Attributes
Implement Control Strategy
Fate & Purge Studies
Determination of Carryover
Technical Assessments and Consultation
Method Development & Validation
Luminata™ Software for Tracking, Mapping Impurities and Reporting.