Telix Pharmaceuticals Selects Goodwin Biotechnology as Manufacturing Scale-up Partner

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May 02, 2018, 10:14 ET

MELBOURNE, Australia and PLANTATION, Fla., May 2, 2018 /PRNewswire/ -- Telix Pharmaceuticals Limited (Telix) (ASX:TLX), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or "molecularly-targeted radiation" (MTR), has selected Goodwin Biotechnology, Inc. (Goodwin) to optimize the process for cGMP manufacturing of its renal cancer imaging antibody drug conjugate TLX-250.The product will be used in Telix's Phase III clinical study for the diagnostic imaging and staging of patients with clear cell renal cancer, and post-approval commercialization.

Goodwin Biotechnology, Inc. is a US-based, uniquely qualified and flexible full GMP Contract Development and Manufacturing Organization (CDMO) that offers a fully integrated Single Source Solution™ from cell line development, process development, scale-up, cGMP contract manufacturing, and aseptic Fill/Finish of mammalian cell-culture derived monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs) for early- and late-stage clinical trials.

CEO Dr. Christian Behrenbruch stated, "The radiopharmaceutical landscape has historically suffered from a lack of effective late-stage product development. Vendor selection is important to product development and as such we have selected Goodwin Biotechnology for manufacturing scale-up because of their track-record in antibody conjugation, including radiopharmaceuticals."

"It was clear from the start that the Telix team is an experienced group of biopharma clinicians and executives, with a passion for radiation biology and oncology'" said Karl Pinto, Chief Executive Officer at Goodwin Biotechnology. "We share their belief that the time for this technology has arrived and we are impressed by the pipeline development strategy."

"Goodwin's experience with radioimmunoconjugates makes us an excellent partner to move forward with Telix's lead program in renal cancer," noted Muctarr Sesay, PhD, Chief Scientific Officer and Vice President of Bioconjugation at Goodwin Biotechnology. "We're confident that we can optimize a robust process and scale it up to cost-effectively supply sufficient amounts of the Girentuximab Conjugate for radiolabeling in order to meet the demand for the confirmatory Phase III trial and beyond."

About Telix Pharmaceuticals Limited
Telix Pharmaceuticals Limited (Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or "molecularly-targeted radiation" (MTR). The company is headquartered in Melbourne, Australia with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information visit www.telixpharma.com.

About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a uniquely qualified and flexible CDMO that offers a Single Source Solution™ for our clients from cell line development (with a strategic partner), exploratory proof-of-concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Biologic Drug Conjugates including Antibody Drug Conjugates (ADCs) for early- and late-stage clinical trials. By working with Goodwin Biotechnology, clients can enhance the value of their product candidates with clear development and manufacturing strategies, as well as a road map to meet the appropriate quality requirements from the milligram and gram scale to hundreds of gram quantities as the product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients' lives. With over 25 years of experience as an independent and fully integrated contract manufacturer of biologics, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology has been awarded Frost & Sullivan's Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing in 2014. In addition, Goodwin Biotechnology was awarded "Best in Sector: Biopharmaceutical Contract Development & Manufacturing" at Acquisition International magazine's 2015 Sector Performance Awards. Last year, Goodwin Biotechnology received Global Health & Pharma's 2017 awards for Best for BioProcess Development & cGMP Manufacturing and Best in Mammalian Cell Culture Process Development & cGMP Manufacturing. Most recently, Goodwin received the Biologics cGMP Manufacturer of the Year 2018 award by Global Health & Pharma News. Click here to view the press releases and journal publications on Biologic Drug Conjugates! Additional information may be found at http://www.GoodwinBio.com.