uip

The University of Iowa Pharmaceuticals

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.

INTERCEPT PHARMACEUTICALS RECEIVES FDA APPROVAL FOR OCALIVA®

Intercept Pharmaceuticals, Inc. received FDA approval for the orphan drug Ocaliva on May 27, 2016 – one of only 22 NMEs (New Molecular Entities) to receive approval by the FDA!  It is indicated for the treatment of Primary Biliary Cholangitis in patients with an inadequate response to UDCA or as monotherapy – PBC is a disease for which there has not been a significant new treatment in nearly 20 years.  Intercept is a long-standing client of UIP’s.  UIP’s analytical laboratory is a laboratory of record in their NDA for this drug product.

UIP HOSTS FDA INSPECTION

An FDA Inspector conducted a general cGMP and preapproval inspection of UIP in November 2015 (both the manufacturing and laboratory site were inspected). This preapproval portion of the inspection was for two different products; a generic sterile injectable solution manufactured by UIP and an oral, immediate release tablet product containing an NCE on which UIP performs finished product and stability testing. This latter product was originally formulated by UIP. The latter product is intended for the treatment of liver disease and is on an accelerated approval track. The inspector completed the inspection and did not leave a Form 483 at either site. This inspection brings to 4 the number of successful preapproval inspections UIP has hosted since 2009. This is a significant accomplishment for UIP.

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 (cGMPs) for over 40 years!
  • The facility is the only one of its kind offering the range and scope of services needed by commercial clients.
  • Virtually every type of dosage form can be produced.
  • UIP serves a broad spectrum of clients of all sizes in the pharmaceutical and biotechnology industries and has performed work for pharmaceutical companies throughout the United States and the world. Additionally, UIP has performed work for numerous government agencies, including the National Cancer Institute, Centers for Disease Control, National Institutes of Health, and Food and Drug Administration.
  • UIP is an FDA-registered facility 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.
  • UIP has produced numerous products for use in the EU and passed numerous QP audits.
  • QP release services are available 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

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...