Biosimilars by Design

Biologicals represent the fastest growing segment of the pharmaceutical market and over 30 branded biological with sales in excess of $50 billion are facing patent expirations. That yields a significant business opportunity to develop Biosimilars and Biobetters.

Manufacturing biologics can be a challenge. With nearly 20 years of experience as a biological contract manufacturing organization, GBI has worked on a number of innovative biologics for companies of all sizes from large multinational pharmaceutical firms to small entrepreneurs.

To help you make an impact in this market, We are dedicated to partnering with you on your project.

We Will Design Your Analytical Approach

We have a wide array of analytical assays to demonstrate adequate comparability, in addition to full characterization, safety, and stability studies that are essential in testing and stability through freeze/thaw cycles, essential in testing of biosimilars and biobetter compounds. Based on our findings, We’ll provide a side-by-side comparison of the reference protein and your follow-on compound. It must be recognized, however, that there may be a need for additional preclinical or even clinical work if there are differences between the two.

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We Will help Design your Regulatory Strategy

We work with you to develop a strategy to gain regulatory approval of your biosimilar / biobetter, including an IND and BLA filing in accordance with the requirements of the relevant agency (i.e., FDA, EMEA, WHO, etc.).

Consider Us Counselors / Advisors

But most importantly, our Clients call Us Partners. Whether you’re ready to select a CMO or just thinking about it, talk to us. We’ll review your requirements then share our expertise and experience to design the appropriate manufacturing, analytical and regulatory strategies. Our focus is on being your strategic partner who will design a plan that:

• Produces the highest quality material that meets appropriate quality and regulatory requirements
• Is time and operationally efficient
• Is cost effective

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Or Contact Us

Goodwin Biotechnology
Telephone: (954) 327-9639
E-mail: info@goodwinbio.com