Regis Technologies, Inc.

Regis Technologies, Inc., partners with pharmaceutical and biotechnology companies to help expedite drugs to market. We offer unrivaled expertise in synthesis and separations services to advance your active pharmaceutical ingredients (API) from initial process development and scale-up development, to final validation and commercial manufacturing. From our extensive organic expertise and collegiate collaborations, we can deliver the added value of our innovative, proprietary chromatography products, especially those with a chiral emphasis. And, we continue to offer fine organic chemicals as we have for 50 years.
GMP Manufacturing Services
Regis Technologies partners with its customers to produce Active Pharmaceutical Ingredients (APIs) and intermediates. We have manufactured high value intermediates and APIs under GMP for over 20 years. This service can advance projects from initial process development, scale-up development through final validation and commercial manufacturing. RegisSEP(TM) SFC Separations Services, a superior separations technology that uses environmentally friendly carbon dioxide, is our most recent addition to our synthesis services.
Chromatography Products
Regis Technologies is a leading manufacturer of chromatography products, especially those with a chiral emphasis. We offer our proprietary Chiral Stationary Phases and HPLC columns as well as IAM Drug Discovery Columns, RAM and ISRP Direct Injection Columns, Ion Pairing Reagents and Buffers, and GC Derivatization Reagents. Our SFC separations service is an exciting addition to these capabilities.
Pharmaceutical Services
Regis Pharmaceutical Services support the filing of a Drug Master File (DMF) or Chemical Manufacturing Control (CMC) with veteran industry professionals who will collaborate with you throughout the DMF or CMC process.
Fine Chemicals
Regis Technologies has manufactured high purity fine organic chemicals according to controlled manufacturing procedures for over 50 years.
Located in Morton Grove, a suburb of Chicago, Regis Technologies, Inc., is a privately held company founded in 1956 and operated by the Glunz family. Regis continually updates and maintains a modern 36,000 square foot facility. Regis became a fully compliant GMP organization in 1993. By 2002, Regis expanded and improved every lab and manufacturing area. This included a new production facility with six dedicated reactor suites, individual kilo lab suites, an expanded quality control department and the installation of a cryogenic reactor. In 2006, we completed another multi-million dollar expansion with additional production labs, individual kilo lab suites and reactor suites.

History
Celebrating Over 50 Years of Service
Regis Technologies, Inc. is proud to have a rich history in serving the life science industry. Since its opening in 1956, Regis has earned a worldwide reputation for excellence in chromatography products and its capability to synthesize complex molecules for the pharmaceutical industry. Few companies can claim this long standing history of success and innovation while continuing to grow into the future.
As an innovator, Regis initially concentrated on custom synthetic chemistry for the emerging field of psychopharmacology. Later it moved into gas and liquid chromatography, and more recently developed expertise in synthesizing drugs for all stages of drug development. Today, Regis serves startup biotechnology companies and large, multinational pharmaceutical corporations helping to expedite new drugs to market.
Regis Technologies, Inc. continues to enjoy growth by providing expanded services for drug development, including process research, analytical method development, scale-up, validation, stability studies, and commercialization. Additionally, we are expanding our chromatographic separation capability by adding Super Critical Fluid Chromatography (SCF), an environmentally friendly technology. Now, with a dedicated staff and a new Synthetic Research Laboratory wing, Regis continues to broaden its capacity to serve the pharmaceutical industry.
Milestones
1956
Regis Chemical Company was founded on North Wells Street, initially synthesizing indole compounds for pharmaceutical research. The family-run business was based on the values of Louis Glunz I, who started a family enterprise dedicated to innovation, customer service, quality and a commitment to community.
1959
Awarded first contract with NIH; began an era of government research contracts.
1965
Relocated to North Franklin Street with expanded synthetic capabilities.
1966
Began to provide chromatography products for customers around the world. First product was a reagent kit for analyzing natural protein amino acids by gas chromatography (GC) for the first time. The line of derivatization reagents has since expanded into a full line of derivatization products built around our flagship silylation reagent: Regisil(R).
1970
Began to develop and offer HPLC columns and packings when Dr. John Perry joined Regis.
1972
Moved to Morton Grove and began offering chiral chromatography columns. Working with Dr. Pirkle, Regis developed and marketed a line of Pirkle Concept HPLC columns and packings. These chiral columns continue to offer advantages in efficiency, stability, and the useful advantage of reversing enantiomer elution.
1986
Regis' Tom Pinkerton developed Restricted Access Media (RAM) columns to permit the direct injection of serum for drug analyses.
1988
Regis' Dr. Charles Pidgeon's developed Immobilized Artificial Membrane (IAM) columns to enable the prediction of drug membrane permeability.
1993
Changed name to Regis Technologies, Inc., reflective of products and services we provide; made commitment to FDA's Good Manufacturing Practices (GMP).
1995
Manufactured clinical trial supplies of Viracept, a market leader among HIV Protease Inhibitor drugs.
1998
Opened a new GMP Production plant at the Morton Grove facility with isolated reactor bays.
2002
Doubled Morton Grove facility through adjacent warehouse acquisition
2006
Celebrates 50 years of service to government, university research laboratories, pharmaceutical manufacturers; opens a new Synthetic Research Wing
2006
New chemical research wing is opened with laboratories, adjoining offices, and conference rooms.
2007
Regis adds Supercritical Fluid Chromatography (SFC) services to its stable of separation capabilities. This environmentally friendly technique, using liquid CO2 as the primary mobile phase, is being applied at Regis in kilo quantity separations, following the GMP guidelines of the FDA.
2008
A new analytical center is opened. The facility includes laboratories, offices, company meeting rooms and locker rooms. Instrumentation is expanded to include NMR, GC-MS, and HPLC-MS.
2008
Regis opens a new Analytical Method Development and Quality Control laboratory. The expansion at the existing site adds 8,000 square feet of new laboratory space, and includes a 400 MHz Bruker NMR.
2010
Regis installs new Syspro ERP system and Unipoint Quality Management System.
2011
Regis installs GL Filtration contained Filter Drier to allow our chemists to work with more potent compounds.
2012
Regis installs Chromeleon software to contol laboratory instruments.
2013
Regis Technologies New Website Launched.
Manufacturing Facility Details


Facility Specifics
FDA Registered
Specializing in active pharmaceutical ingredients (APIs)
Site registration number 1416120
Building
Brick and concrete construction
Aggregate floor space of approximately 36,000 square feet Situated on 65,000 square feet of land
Houses offices, a technical library, an analytical laboratory, packaging and shipping departments, laboratories for bench scale chemistry, a large glassware laboratory, and a production area
Designed for the performance of all types of chemical syntheses, from bench scale through production
Safety & Pollution Controls
Laboratory safety and air pollution control equipment are incorporated throughout the building for maximum efficiency as well as personnel comfort and protection, and includes:
Efficient fume hood and production exhaust trunks
An exhaust scrubbing system where all exhausts flow through a packed column to remove contaminants prior to release into the atmosphere
An air make-up system where HEPA filtered air is fed into the production suites, minimizing the potential for contamination between laboratories
Safety showers and eyewashes
Sprinkler equipped production, process laboratory, finishing, and solvent storage areas
A waste solvent storage area separate from the rest of the facility
Production Area
Consists of seven suites containing pairs of reactors, a preparative separations laboratory, and isolated finishing areas
Individual Reactor Suites
Two 500 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 48 x 20 centrifuge.
Two 300 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 40 x 20 centrifuge
Two 200 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 40 x 20 centrifuge
Two 100 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or refluxo & Tolhurst 40 x 20 centrifuge
Two 200 gallon glass lined Pfaudler jacketed reactors, equipped with agitator and glass condenser for distillation or reflux o & Tolhurst 40 x 20 centrifuge
One 150 gallon Hastelloy reactor for running cryogenic reactions down to minus 85?C
Two 25 gallon glass lined DeDietrich jacketed reactors, equipped with agitator and glass condenser for distillation or reflux
One 50 gallon glass lined Pfaudler jacketed reactor, equipped with agitator and glass condenser for distillation or reflux & one 50 gallon DeDietrich jacketed reactor
Two 50 gallon glass lined Pfaudler jacketed reactor, equipped with agitator and glass condenser for distillation or reflux
Small and large scale glassware laboratories for development, scale-up, and small scale production.
Ancillary Production Equipment
Parr rocker type, high pressure hydrogenation apparatus (Model 4000); capacity: 500 mL; up to 400 atm. and 350?C
Aminco rocker type, high pressure hydrogenation apparatus; capacity: 1 gallon; up to 400 atm. and 350?C
Thin film distillation unit
Sparkler filter press; horizontal stainless steel plates
T. Shriver 18" polypropylene filter press
Ceramic filter funnels, 18 in. and 24 in. diameters