Goodwin Biotechnology offers a full range of mammalian cell culture Process Development and Control Services, and cGMP manufacturing projects ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept or toxicology product material to GMP Process Development services for licensed manufacturing.
Regulatory & CMC Support
At Goodwin Biotechnology, we provide expert Regulatory Support to our clients to assist them in quickly and effectively moving their drug candidates through the regulatory application and review process. Goodwin Biotechnology provides full regulatory support services for projects beginning with process development services and initiatives in support of toxicology study materials through the preparation of Chemistry, Manufacturing & Controls (CMC) information for IND filings and amendments.
Characterization of a biologic is essential to measure levels of a drug (pharmacokinetics) in human serum, as well as to detect the presence of neutralizing antibodies typically generated by a patient’s immune system against a protein-based drug during the clinical trial. Analytical methods are essential to insure the safety, purity, and efficacy of your drug candidate.
The Analytical QC group performs product release and ICH compliant stability testing of GMP material using the qualified and / or validated methods.
An integral element of aseptic processing is the ability to monitor facilities and processes for microbial organisms. Goodwin has established procedures for evaluation of all GMP areas and processes to ensure continuous control. Sterility testing on all final vialed products is outsourced to a qualified independent safety testing lab to provide to our clients additional and objective assurance that their products are safe and have been manufactured in accordance with USP and CFR testing requirements.
It is the policy of Goodwin Biotechnology to use appropriate management systems to carry out our mission. Quality is the intrinsic focus of all management practices that make up these systems. These practices include the following elements: proper planning, performance of appropriate tasks, timely assessment, and continuous improvement of established processes. By addressing these elements in the research, development, operations, and support activities, defined goals are met and both the Goodwin Biotechnology and the client requirements are satisfied. All work is performed with dedication to excellence and with an objective of dynamic and continuous improvement.
The Goodwin Biotechnology project management approach is based on the value we have found through open communications with you and our Subject Matter Experts (SMEs) – a level of transparency that we’re sure you’ll find refreshing. This level of transparency is critical for the timely completion of your complex biopharmaceutical project.
As part of the foundation for every project, Goodwin Biotechnology assembles a Project Team with a single Project Manager (PM) as the point-of-contact. Your PM is an experienced veteran in biological manufacturing and will be the advocate for you within Goodwin Biotechnology to ensure that project timelines are met and that information is communicated, both ways, in a timely manner.
Whether you’re ready to select a CDMO or just thinking about it, talk to us. We’ll review your requirements then share our expertise and experience to design the appropriate technical, quality, chemical manufacturing and controls (CMC) and regulatory strategies for your biopharmaceutical candidate.
Cell Line Development
Goodwin Biotechnology scientists have considerable experience in the development of cell lines for cGMP manufacturing for clinical studies through commercial manufacturing. In addition, working with our partners, we can develop cell lines from cDNA that you provide. Our partners offer their own proprietary vectors to develop cell lines that can routinely produce up to 4g/L in CHO cell lines.
To learn more about how any of the Support Solutions offered by Goodwin Biotechnology