Tuesday, May 19, 2015
Highly Specialized Fill and Finish
For more than 20 years, Goodwin Biotechnology has developed into a uniquely qualified CDMO that provides a Single Source Solution™ for clients by offering cell line development, exploratory proof-of-concept projects through Process Development and cGMP manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and biologic drug conjugates including antibody drug conjugates (ADCs) for small startup ventures to large, multi-national companies as well as government agencies and medical institutions for early and late stage clinical trials. As part of their integrated services offerings, Goodwin Biotechnology operates an ISO5 cGMP filling suite that can accommodate liquid filling of a wide range of configurations to meet specific and unique client requirements.
Goodwin Biotechnology 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.
Most recently, Goodwin Technology was selected to complete a novel Fill/Finish project, as well as Quality release and stability testing for a cancer vaccine that is based on the Human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH) tumor-specific protein. This was geared towards enabling Phase I clinical trials in patients suffering from various solid tumor cancers. Panacea Pharmaceuticals, which partnered with Goodwin in this project, described the Goodwin Biotechnology staff as extremely responsive, flexible, and solutions oriented. It is easy to see why many companies prefer to work with Goodwin Biotechnology on their biological projects.
Goodwin Technology has a fill operation that is fully validated for batch fills up to 2,000 vials per shift and volumes of 0.5mL to 10.0mL per vial. Additional features offered include:
· Utilization of a programmable pump and manual fill nozzle (semi-automation) to provide improved yields for small lot sizes.
· Vial stoppering immediately after filling by a second operator before removal from the fill room.
· Fill checks that are performed at predetermined levels. For all acceptable fill volumes, this semi-automated process has consistently met all set standards.
· Observation and environmental monitoring of all fill operations by Quality personnel.
· Monitoring of sealing and fill checks by Quality personnel.
What’s more, Goodwin Biotechnology has lyophilization capabilities for small- to mid-scale runs for both GMP and non-GMP projects, and can accommodate a wide range of vial sizes and configurations. In addition, Goodwin Biotechnology has successfully provided lyophilization services for a multinational company to supply GMP material to test a commercially available product.
Goodwin Biotechnology has an impressive track record of providing solutions that are customized and tailored to meet specific client needs. It has in place a comprehensive infrastructure that is required to deliver quality solutions, such as ready-for-clinical-trials, Final Vialed Product (FVP). On top of the infrastructure, the team members at Goodwin Biotechnology are highly skilled and experienced, and as a team, place a great level of emphasis on quality and being responsive to clients’ needs in an effort to enhance the value of their drug candidates.