Goodwin Biotechnology was Selected by Panacea Pharmaceuticals
News May 28, 2015
Goodwin Biotechnology, Inc. was selected by Panacea Pharmaceuticals, Inc. to complete a novel Fill / Finish project, as well as Quality Control release and stability testing for a therapeutic, nanoparticle cancer vaccine based on the Human Aspartyl (Asparaginyl) β‐Hydroxylase (HAAH) tumor‐specific protein to support Phase I clinical trials in patients with various solid tumor cancers.
“Over the last year, we partnered with Goodwin Biotechnology on a bioconjugation project and have found them to be extremely responsive and flexible. They had an innovative approach to address some rather significant challenges in an effort to move our project forward,” noted Dr. Steven A. Fuller, Ph.D., Chief Operating Officer at Panacea Pharmaceuticals.
Dr. Fuller continued, “When we identified the need to select a company for our Fill / Finish project that involves a unique injector cartridge filling procedure for our other lead compound, we evaluated Goodwin’s capabilities and we were pleased to find out that their approach to niche Fill / Finish projects was just as flexible and solutions oriented. When coupling that with the sophistication of their quality system they’ve put in place and the technical expertise of their staff, the decision became obvious.”
“We are pleased to have Panacea Pharmaceuticals work with us on their two lead compounds,” said SooYoung S. Lee, Ph.D., Chief Operating Officer at Goodwin Biotechnology. “While being selected for a Bioconjugation or Cell Culture‐based project is typical, based on the many years of successful track records and our commitment to bring advances to those fields, it is more rewarding to know that our investment to build and offer the comprehensive infrastructure required to deliver ready‐for‐clinical‐trials, Final Vialed Product (FVP) and provide integrated solutions to meet specific and unique requirements of our clients has been helpful for Panacea. Our staff takes great pride in their respective skill sets and, as a team, we all place a great level of emphasis on quality and being responsive to our client’s needs to enhance the value of our clients’ drug candidates.”
Goodwin Biotechnology operates an ISO5 cGMP filling suite that can accommodate liquid filling of a wide range of configurations to meet specific and unique clients’ requirement. For more than 20 years, Goodwin Biotechnology has been manufacturing Bulk Drug Substance and performing Fill / Finish services for small startup ventures to large, multi‐national companies as well as government agencies and medical institutions.
Goodwin has successfully completed numerous traditional Fill / Finish and Drug Product manufacturing projects, as well as customized, specialized Fill / Finish projects for small volume fills, light sensitive products, and extremely fragile biological drugs for which large‐scale, automated fill systems are not appropriate.
H7N9 Influenza Vaccine Clinical Trials CommenceNews
Two new clinical trials testing an experimental vaccine to prevent influenza caused by an H7N9 influenza virus are now enrolling volunteers at sites across the United States. The Phase 2 studies will test different dosages of the inactivated influenza vaccine candidate as well as different vaccination schedules. The studies also will evaluate whether an adjuvant boosts the immune responses of people receiving the vaccine.
Study Extends Potential of Personalized Cell-based ImmunotherapiesNews
New methods developed for the study could be applied to devise personalized, cell-based immunotherapies for epithelial ovarian cancer or other types of tumorsREAD MORE
Hope for Hot Flushes: New Class of Menopause Drugs Reduces SeverityNews
A new class of experimental drugs reduces hot flushes in menopausal women by almost three-quarters in just three days. The new analysis, published in the journal Menopause, also revealed sleep and concentration significantly improved in the three-day window.