Goodwin Biotechnology, Inc.

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Description

Goodwin Biotechnology has established a Drug Master File (DMF) with the FDA. Goodwin Biotechnology also has substantial experience in submitting type II DMF's to the U.S. FDA, and we have a broad range of experience in submitting DMF's for active pharmaceutical ingredients, Drug Products and IND's for biologic products. Goodwin Biotechnology strictly adheres to the regulations associated with the development of every new pharmaceutical ingredient, biologic product.

Goodwin Biotechnology, Inc. is well-suited to partner with you to develop your Biosimilar product candidates. Goodwin Biotechnology is a full-service and integrated CMO capable of taking a biologic (both Biosimilar and innovator) expressed in a mammalian cell line, from cDNA cell line development through to GMP master cell banking, cell culture, purification and bioconjugation process development, scale-up, GLP manufacturing for tox studies and subsequent cGMP manufacturing and fill/finish for human trials --- i.e. from bench to clinic.

Goodwin Biotechnology has established a collaboration with Coldstream Laboratories to develop and manufacture highly potent, cytotoxic antibody drug conjugates by leveraging Goodwin Biotechnology's experience and expertise in bioconjugation. Coldstream Laboratories is a specialty manufacturer of sterile injectable drugs and operates a state-of-the-art parenteral manufacturing facility in Lexington, Kentucky. They specialize in the development and manufacture of highly toxic compounds to produce safe and effective drug products.

Goodwin Biotechnology's senior operational and quality staff have decades of experience in cGMP manufacturing, which includes work at several leading biopharmaceutical companies. Therefore, our clients have the assurance of knowing that the individuals entrusted with the manufacture of their products are seasoned industry professionals with excellent track records. However, we don’t stop there. Our goal is to provide excellent service that not only meets, but exceeds our client’s expectations.

Goodwin Biotechnology maintains an ISO5 filling suite that provides customized, economical, and compliant liquid filling of client products under cGMP and non-GMP conditions. In fact, for over 20 years we've been manufacturing material and performing Fill and Finish services for a large, multi-national company that they use to test a commercial product. Our fill operation is fully validated for batch fills up to 2,000 vials and volumes of 0.5mL to 10.0mL per vial. We can also accommodate fill volumes to meet your needs.

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