Downstream Protein Purification
Goodwin has decades of experience and proven track record in the development of robust and scalable protein downstream purification processes for purification development to generate non-GMP materials for animal (e.g., non-Human Primates) proof-of-concept studies and product characterization. Goodwin also has performed the manufacturing of mammalian cell culture derived biologics for use in Toxicity and animal safety studies, and First in Humans (FIH) through to late Phase human clinical trials. Goodwin is currently upgrading its GMP manufacturing facility and capabilities (e.g., installing a 2000L Single-use manufacturing suite) and anticipates to be ready for commercial manufacturing by the end of 2021.
Our development teams work closely with the manufacturing, QA/QC/RA and Project Management teams to define and document all new processes in order to generate a reproducible, robust, scalable, and cost-effective processes in a flexible manner.
Full Downstream Antibody and Recombinant Protein Purification Capabilities
Goodwin Biotechnology’s downstream protein purification capabilities include downstream process development and cGMP purification services. Goodwin has a broad range of experience with the following types of biologics:
- Monoclonal Antibodies, Antibody Fragments (including IgG, IgA, and IgM subclasses)
- Complex biologics such as antibody Fusion proteins and Bispecific antibodies
- Recombinant Proteins and Fusion proteins
- Growth Factors, Cytokines, Exosomes
- Antibody Drug Conjugates
- Radiolabeled Antibodies
- Other Bioconjugates
Goodwin Biotechnology is an expert in resin screening and multiple chromatography techniques including but not limited to affinity, ion exchange, hydrophobic interaction, mixed mode, MEP chromatography, charged membrane, and other processes. Our experience includes UFDF processes using TFF technologies in both flat plate and hollow fiber formats. Viral clearance techniques employed include low pH and other chemical inactivation, nanofiltration for virus removal, process, and product characterization. We work closely with viral filtration media providers to develop a filtration process that works within the confines of your process and product requirements and provides the necessary viral removal.
Meet the Downstream Process Development Technical Leadership
Joandiet Castaneda, M. Sc.
Joandiet leads the downstream development team at Goodwin Biotechnology as the Manager of the Downstream Process Development department. He manages the development and optimization of downstream protein purification processes and their technical transfer, scale up, and technical support for the downstream cGMP manufacturing group. In this role, Joandiet provides technical expertise in addressing scientific and technical problems related to process purification technology in cGMP manufacturing. His group constantly evaluates emerging technologies in purification process for the production of biopharmaceutical candidates. He has hands on experience with chromatography based processing methods, virus filtration and tangential flow filtration techniques.
Joandiet earned his Bachelor’s degree in Chemical Engineering at The Higher Polytechnic Institute of Havana “Jose Antonio Echeveria” and a Master’s of Science degree in Chemical Engineering and Processes from the Roviri i Virgili University in Tarragona, Spain.
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