Goodwin will Prioritize any Project Addressing the Coronavirus Pandemic
To help combat the novel coronavirus (SARS-CoV-2) pandemic, Goodwin Biotechnology is prioritizing and staffing any biologics development or manufacturing project aimed at addressing this global healthcare crisis. There is a critical need to fast track the development of such projects as highlighted by the United States’ Operation Warp Speed initiative.
Goodwin’s Fully Integrated Services Stand Ready
Goodwin provides resources that can be leveraged to move a biologics vaccine, monoclonal antibody development, and other critical projects forward that include:
- Quick stable CHO Pools yielding mg to grams of antibody or recombinant protein starting from sequence in 8 weeks
- Research Cell Bank to clinical ready material in 5 to 6 months or from sequence in 9 to 10 months
- Prioritization of Upstream and Downstream production and analytics
- Bioconjugations
- Formulation studies
- Fill and Finish services
- Scale-up services for TOX and GMP compliant biologics
- Regulatory support for fast track approval of your project with the FDA
Goodwin Biotechnology is a fully integrated Single Source Solution™ provider and is FDA registered, worked with over 150 clients on almost 500 different products (Ph-I/II/III) and helped file over 45 INDs. Reach out to us and find out how we can help you win the race to beat COVID-19!
Goodwin Challenges the Project Timeline for COVID-19
The world is faced with a challenge of bringing life saving treatments addressing COVID-19 infection to the patient without risk. Let’s discuss how Goodwin can release cGMP compliant biologics in less than six months after receipt of the gene sequence such as displayed in the following example:
The following helps to illustrate the work flow of a typical project:
- Generation of Material for PK studies in NHP available: week 12
- Completion of intermediate RCB (iRCB): week 12
- Completion of IND enabling activities: week 16
- Completion of GMP manufacturing run: week 18
- Completion of MCB/ testing: week 27
GigaGen and Goodwin Initiate Large-Scale Manufacturing of First-in-Class Recombinant Hyperimmune Drug for COVID-19
Goodwin Biotechnology, Inc. and GigaGen, Inc. are working together on an exciting project to manufacture GigaGen’s GIGA-2050, a first-in-class recombinant hyperimmune drug that has demonstrated an enhanced therapeutic potential for the treatment of COVID-19 infection.