uip

The University of Iowa Pharmaceuticals

UIP Chosen as Vendor for NCATS Drug Product Development, Manufacture, and Stability Studies

The University of Iowa Pharmaceuticals (UIP) is very excited that it has been chosen as a vendor for the NCATS (National Center for Advancing Translational Sciences) Request for Proposal (RFP) No. N01TR-17-2003, “CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies”.  NCATS at the NIH (National Institutes of Health) studies translation on a system-wide level as a scientific and operational problem to accelerate the development of treatments and preventive strategies for a wide range of diseases.  Within NCATS, the Division of Pre-Clinical Innovation (DPI) plans, conducts, and uses both internal and contract resources to advance collaborative research projects across the pre-clinical phases of the translational science spectrum.  The goal of NCATS in selecting UIP as a vendor is to obtain contract research services to support the development, manufacturing, and stability studies of dosage forms of experimental therapeutics.  The UIP application for this contract also included faculty from the UI College of Pharmacy that participate in the UIP Development Consortium (UIPDC).  UIPDC is a formal connection between UIP and faculty in the College of Pharmacy where faculty can work with UIP and/or their students on pre-clinical drug development activities.

This project has been funded in whole or in part with Federal funds from the National Center for Advancing Translational Sciences, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN271201700019I.

 

UIP & Fervent

UIP will be working with Fervent Pharmaceuticals to develop its treatment for hot flashes and other vasomotor symptoms.  UIP involvement will be focused on formulation development aspects of the Fervent program, and UIP will manufacture development-scale clinical batches for its upcoming Phase II trial.  Fervent CEO George Royster is excited about the partnership: “UIP offers Fervent the perfect blend of drug development expertise and experience. They’ve been practicing cGMP-compliant formulation development and product manufacturing for 40 years. I’ve been extremely impressed by their capabilities and their facility, which is the only one of its kind offering the range and scope of services needed by commercial clients like us.”  For more information go to:

http://ferventpharma.com/university-of-iowa-pharmaceuticals-added-to-growing-list-of-fervent-strategic-partners/

http://ferventpharma.com/

 

UIP TO PARTICIPATE IN NIIMBL VIA NIPTE

U.S. Secretary of Commerce Penny Pritzker announced on December 16, 2016 an award of $70 million to the new National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), the eleventh institute in the Manufacturing USA network.  This is the first institute with a focus area proposed by industry and the first funded by the U.S. Department of Commerce (DOC).  UIP is part of NIIMBL through the UI College of Pharmacy via NIPTE (National Institute for Pharmaceutical Technology and Education).  NIIMBL will help to advance U.S. leadership in the biopharmaceutical industry, foster economic development, improve medical treatments and ensure a qualified workforce by collaborating with educational institutions to develop new training programs matched to specific biopharma skill needs.

UI BREAKS GROUND ON NEW PHARMACY BUILDING

On September 29, 2016 UI officially broke ground on a new $96.3 million pharmacy building that will feature cutting-edge research laboratories, innovative technology, and collaborative learning spaces.  The lower level of this new building will be home to UIP’s new sterile products manufacturing area.  This new sterile manufacturing area will be approximately 16,000 square feet and include two complete isolator lines, each with its own lyophilizer.  This will increase UIP’s batch size capacity approximately 5-fold to 20,000 vials/batch.  UIP will continue to retain its ability to make small, IND enabling batches for clinical supplies with this facility.

The University of Iowa Pharmaceuticals

OVERVIEW

The University of Iowa Pharmaceuticals (UIP) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States. UIP has been developing formulations, manufacturing products, and conducting analytical testing in compliance with current Good Manufacturing Practices (GMPs) for over 40 years!

The facility is the only one of its kind, offering the range and scope of services needed by commercial clients, including those within the EU. By being able to produce virtually every type of dosage form, UIP can serve a broad spectrum of clients of all sizes in the pharmaceutical and biotechnology industries, and can perform work for international pharmaceutical companies.

University of Iowa Pharmaceuticals has performed work for numerous government agencies, including:

  • The National Cancer Institute
  • Centers for Disease Control
  • National Institutes of Health
  • Food and Drug Administration

UIP is an FDA-registered pharmaceutical manufacturing facility and is:

  • Compliant with 21 CFR parts 11, 210, and 211,
  • Licensed by the DEA to handle controlled substances (Schedules I - V), and
  • Capable of handling most potent/cytotoxic materials.

In addition to meeting US FDA regulations, UIP has passed numerous QP audits. We can offer QP release services through Russell Thomson of TPQ Consultancy.

CONTACT US

Please call or send an e-mail to discuss project needs, schedule a visit and tour, or audit our facilities and procedures. For more information please contact either of the following contacts:

Mickey L. Wells, Ph.D.,
UIP Director
E-mail: mickey-wells@uiowa.edu

Randy R. Yeates, R. Ph., M.B.A.,
Director, Business Development
E-mail: randhall-yeates@uiowa.edu

Visits & Directions

OTHER NEWS & EVENTS

August 2017: UIP chosen as NCATS vendor...Read More...

April 2017: UIP and Fervent begin working together to advance one of Fervent's development programs...Read More...

December 2016: U.S. Secretary of Commerce Penny Pritzker announced on this day an award of $70 million...Read More...

September 2016: UI officially broke ground on a new $96.3 million pharmacy building...Read More...

June 2016: UIP has added two Waters ACQUITY QDa detector equipped LC systems to our analytical laboratory...Read More...

May 2016: Intercept Pharmaceuticals, Inc. received FDA approval for the orphan drug Ocaliva... Read More...

March 2016: UIP is in the process of adding 3 Manufacturing Specialists in the Non-Sterile Processing area... Read More...

Oct 2015: UIP has added additional staff including 3 chemists in the analytical laboratory and Ramprakash Govindarajan, Ph.D. who will be heading up our Preformulation/Formulation Development Group... Read More...

July 2015: UIP has added a second Waters ACQUITY UPLC H-Class System to our analytical laboratory... Read More...

June 2015: UIP has installed an additional 1120 cubic feet of frozen storage space... Read More...

April 2015: UIP has added a Waters ACQUITY UPLC H-Class System to our analytical laboratory... Read More...

July 2014: UIP has received and is in the process of qualifying a new FP Developments Model 1270-2017 Semi-Automatic Vial Inspection Machine ... Read More...

June 2014: UIP has completed renovation of an approximately 300 square foot space ... Read More...

March 2014: UIP has purchased and received a new 225 gallon stainless steel mixing tank ... Read More...

December 2013-January 2014: In another round of new hiring UIP has hired four additional employees. New personnel include two... Read More...

December 2013: UIP has received and qualified two new Distek Symphony 7100 Dissolution Units with ... Read More...