Based on its recent analysis of the mammalian contract manufacturing services market, Frost & Sullivan recognises Goodwin Biotechnology with the 2014 Global Frost & Sullivan Award for Customer Value Leadership. Goodwin Biotechnology's reputation as one of the most trusted providers of mammalian contract manufacturing and development services has been built on more than 20 years of experience in the bioprocess development and cGMP manufacturing of mammalian cell culture-derived monoclonal antibodies (mAbs), vaccines, and recombinant proteins, and more than 10 years pioneering the field of bioconjugation.
Goodwin Biotechnology championed the concept of 'full integration' in the biopharmaceutical contract manufacturing space. It is a one-stop shop, offering its partners a comprehensive range of services from cell line development and proof-of-concept projects to bioprocess development and the manufacture of material for preclinical / Tox studies as well as early to late phase clinical trials.
Goodwin Biotechnology strives to be a highly flexible partner with its clients by finding customized solutions for the distinctive needs of every project and ensuring smooth implementation all throughout the lifecycle of an engagement. Furthermore, it has enhanced its brand value on a global basis by maintaining high levels of transparency and responsiveness while focusing on quality, and working within budgets and timelines.
The core services offered by Goodwin Biotechnology include cell line development through collaborations, cell culture and purification process development, cell banking, process scale-up, engineering runs for toxicology study materials, and strict adherence to current good manufacturing practices (cGMP) for manufacturing and providing Fill / Finish services for biopharmaceutical candidates used in human clinical trials. The company has also established best-in-class processes for the production of antibody drug conjugates (ADCs), cytotoxic ADCs (CADCs), antibody-chelator conjugates (for radioimmunoconjugates) and other bioconjugates.
"These core services are fully complemented and enhanced by the company's analytical and formulation development capabilities as well as its quality assurance, quality control, regulatory and project management capabilities," said Frost & Sullivan Senior Research Analyst Aiswariya Chidambaram. "The complete and fully-integrated services offered by Goodwin Biotechnology reduce the supply chain complexities and timeline for clients to efficiently meet their preclinical and clinical needs."
"We at Goodwin Biotechnology are honored to be recognized for such a prestigious award, which showcases our orientation towards providing our clients with the best overall value proposition," noted Karl Pinto, CEO of Goodwin Biotechnology. "It is a testament to the company's rich and distinguished history, coupled with its innovative, state-of-the-art technologies, and highly skilled scientists that enables us to meet the expectations of customers across the globe and at various stages of their respective product development cycles. Having addressed challenges pertaining to the manufacturing of complex biological molecules, such as monoclonal antibodies, recombinant therapeutic proteins, vaccines and cytotoxic ADCs (CADCs), Goodwin Biotechnology helps our clients formulate a strategic approach with particular emphasis on critical protein product characterization, process development, and cGMP manufacturing for regulatory compliance."
"Goodwin Biotechnology's time-tested expertise with various host cell types and process optimisation techniques enables seamless technology transfers between R&D and GMP manufacturing for clinical studies," added Chidambaram. "It is one of the few contract manufacturing organisations to have installed capabilities for a number of robust and reproducible cell cultivation technologies, including disposable bioreactors such as, WAVE, perfusion, and stainless steel tank bioreactors."
At the start of every project, Goodwin Biotechnology focuses on optimising and refining the processes to maximize productivity and ensure seamless scale up. Towards that end, the company has hands-on experience in several chromatographic techniques including affinity, ion exchange, hydrophobic interaction, mixed mode, and size-exclusion chromatography. In addition, its ultrafiltration/diafiltration (UF/DF) processes use tangential flow filtration (TFF) technologies in both flat-plate and hollow-fiber formats.
Goodwin Biotechnology also addresses complex issues associated with antibody drug conjugates, including linker design, drug payload selection, and antibody stability in the production of multi-gram lots of conjugated antibodies used globally in clinical trials. Apart from its rich and varied expertise in protein modification through chemical conjugation and enzymatic digestion methods, Goodwin Biotechnology also offers unique specialties such as the production of Fab and F(ab')2 fragments and their subsequent purification as per client specifications.
Each year, Frost & Sullivan presents this award to the company that has demonstrated excellence in implementing strategies that proactively create value for its customers with a focus on improving the return on the investment that customers make in its services or products. The award recognises the company's inordinate focus on enhancing the value that its customers receive, beyond simply good customer service, leading to improved customer retention and, ultimately, customer base expansion.
Frost & Sullivan Best Practices awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.
About Goodwin Biotechnology
Goodwin Biotechnology (GoodwinBio.com) is a world-class CMO that offers a Single Source Solution™ through partnerships with clients for cell line development or exploratory proof of concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs) and other Biologic Drug Conjugates for early and late stage clinical trials. By working with Goodwin Biotechnology, our clients can enhance the value of their product candidates with clear development and manufacturing strategies as well as a road map to meet the highest quality product requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical approval pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients' lives. With over 20 years of experience as an independent contract manufacturer, 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.
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Contact: Goodwin Biotechnology, Inc.
Robin McCallum, MSc
Manager of Business Development
P: 954-327-9656 - E: Info[.]GoodwinBio.com.