Biotechnology Consulting Services
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. Our focus is on being your strategic partner who will design a plan that:
- Produces a product that meets and exceeds quality and regulatory requirements
- Is time and operationally efficient
- Is cost effective
- Assures royalty and license-free, proprietary cleavable and non-cleavable linkers
- Develops processes that are amenable for scale up for clinical trials and commercial-scale cGMP manufacturing
We welcome the opportunity to serve as cGMP consultants or to partner with you as your Single Source Solution™ for process development and cGMP manufacturing of mammalian cell-derived antibodies, vaccines and recombinant proteins / enzymes, as well as Antibody Drug Conjugates (ADCs) and other bioconjugates. We also offer Biopharmaceutical consulting and CMC consulting.
As a strategic partner, our goal is to provide superior flexible service to you that will not only meet, but exceed your expectations. It is with that in mind that we feel you deserve the benefit of our experience. Ask anyone who works at Goodwin Biotechnology and you’ll find that the culture is open and all perspectives are valued. We value all of our clients equally, whether a client is a university or startups to large, multinational biomedical / pharmaceutical firms. We share our considered opinions, offer advice and counsel, but we recognize that at the end of the day, it’s your decision and we move forward accordingly.
Select Goodwin Biotechnology as Your Preferred Partner
Goodwin Biotechnology can complement your efforts to bring promising biomedical advances from the early development stage through human clinical trials. As a full-service, integrated Contract Developing and Manufacturing Organization (CDMO), Goodwin Biotechnology is one of the few CDMOs capable of taking a biopharmaceutical or biologic from cDNA cell line engineering through to GMP cell banking, cell culture, purification, bioconjugation and analytical development, GMP manufacturing and fill/finish of clinical lots — i.e., from bench to clinic.
In addition to a focus on contract cGMP manufacturing of therapeutic and diagnostic antibodies, recombinant proteins and enzymes as well as protein vaccines expressed in mammalian cell lines, one of our core competencies is the conjugation of monoclonal antibodies and other proteins to small molecules, macromolecules, chemical polymers, and radionuclides for immunotherapy and immunodiagnostics. In the area of oncology in particular, we conjugate small molecule anticancer drugs, plant protein toxins, radioisotope metal chelators to cancer-indicated antibodies, dyes, ligands and other proteins for high-potency and diagnostics immunotherapy.
What Clients Say
We work with a number of companies around the world to advance our portfolio of drug candidates, and one of our primary collaborators highly recommended Goodwin Biotechnology based on the track record they had on a number of their projects that Goodwin Biotechnology had worked on over the last six years.
The Goodwin Approach
With nearly 30 years in biopharmaceuticals, Goodwin Biotechnology is one of the most experienced CDMOs in the world. Our clients are from Eastern and Western Europe, North America and Asia, and include biotechnology startup firms, multinational biotechnology and pharmaceutical companies, research institutes, and university laboratories, as well as government institutes and centers. Our experience is based on:
- Over 500 projects involving hundreds of cell lines
- More than 150 satisfied clients
- ~90% repeat business
- More than 85 audits by clients, auditors and regulators, including the FDA
- Participated in 45+ IND filings
- One Single Source SolutionTM from cell line engineering (cDNA) to proof of concept, process development, scale up, and cGMP manufacturing
To learn more or simply discuss your project,