September Fall Special Edition 2021

Goodwin Biotechnology, Inc. — Enhancing the Value of Complex Biopharmaceuticals through its Single Source Solution™


“Goodwin Biotechnology was founded with the main objective of enabling cutting-edge science & technologies to be translated into commercial reality.”

Goodwin Biotechnology, Inc. is a fully integrated, customer-focused cGMP Contract Manufacturing Organization (CMO) of innovative & biosimilar monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs), and other complex biologics. In addition, the company delivers a Single Source Solution™ with a full range of mammalian cell culture development and manufacturing services ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept or toxicology product material to cGMP processes for clinical and licensed, commercial manufacturing.

Goodwin Biotechnology was founded in 1992 and is headquartered in Plantation, Florida, near Miami.

Karl Pinto, Chief Executive Officer of Goodwin Biotechnology, Inc., spoke exclusively to The Silicon Review. Below is an Excerpt.

Q. Have you always been passionate about science and technology?

I am an engineer by education and have always believed that science is a crucial tool in man’s pursuit of happiness. Over my career, my work has always been underpinned by science and technology, ranging from biotechnology to semiconductors and software technologies and, most importantly, their application to the real world. Science ensures a better understanding of what makes the world (and us).

Being a critical contributor to developing a highly complex biologic or biopharmaceutical drug that promises to make a significant impact on people’s lives is a strong driving force for me and the highly skilled scientists and staff at Goodwin Biotechnology. Nearly 30 years ago, we started as a Contract Development and Manufacturing Organization (CDMO) with monoclonal antibodies, recombinant proteins, and vaccines. Since 2001, we also have been developing Antibody Drug Conjugates (ADCs) and have seen important strides in addressing the treatment needs for various cancers, infectious diseases, autoimmune and other diseases.

Q. Tell us what inspired the foundation of Goodwin Biotechnology?

As the science of genetics progressed during the 70s and 80s, it became increasingly clear that moving the science from laboratories into clinical trials was challenging. Goodwin Biotechnology was founded in the early 1990s with the main objective of enabling cutting-edge science & technologies to be translated into commercial reality. There is a huge gap and journey to be traversed between discovering something life-saving and actually saving lives. Goodwin’s mission is to make this journey as efficient and predictable as possible within a strong regulatory environment so that society can benefit from safe and effective drugs.

Q. Given that Goodwin is a pre-eminent provider of high-quality, cost-effective, flexible, and timely cGMP-compliant manufacturing solutions, do you think the company is raising the bar in this segment?

Yes, unlike large CDMOs that may not be as flexible and don’t undertake products that are at a smaller scale (usually, these are also the more complex ones), Goodwin is small and agile, and we partner with our clients in every step of the process to bring the drug at the appropriate scale, compliant and meet the regulatory requirements, to the clinic and eventually towards the market. Goodwin is your partner for the life of your product manufacturing life cycle.

Q. What are your focus areas? And what can you tell us about Single Source Solution™?

Goodwin is client-focused, and we strive to meet our clients’ needs through leveraging the talented scientists that we employ. Some areas of expertise include bioconjugation of recombinant proteins (and antibodies) to various small molecules, production of Extracellular Vesicles from mesenchymal stem cells, developing scalable production processes for complex biologics including fusion proteins, monoclonal and multi-specific antibodies, and more. Our platform Single Source Solution™ provides our clients with unique access to a partner that can take their product from proof of concept to a vialed drug product that is commercially viable all under one roof. The breadth of our capabilities ensures that we can greatly simplify our clients’ supply chains, which is becoming more and more valuable.

Q. Will your company be expanding, bringing on any new products or services that we should be aware of?

Goodwin has launched a significant expansion effort leveraging investment from our Private Equity investment partners. This expansion is catered to our current client base, many of whom will be moving their products from late stage clinical trials to commercialization by Q4 2022. It will enable us to scale our service offerings to cater to our existing and new clients from drug substance to drug product (including vials & syringes) who seem to be under-served by our industry.

Q. Approximately 30 percent of Goodwin scientists have Masters and Ph.D. degrees with experience working at many of the largest global Biopharma and CDMOs. With that said, how did you form your dream squad?

Building a team is paramount in enabling a company like ours to be successful. As we are in a very specialized field, we often need to attract our best senior executives from outside Florida. We have managed to put together a team second to none, due to the impact and influence that professionals can have within a small company environment like ours, the flexible, attractive & multi-cultural work environment we provide, and frankly, the vision and growth opportunity that we have as an organization, in which success they also directly partake. Being based in the beautiful state of Florida also helps! This is a continuous process as we continue to build our team with relevant capabilities & experience, both from within and out of state.

Q. Where do you stand as a company in the current market landscape? And what are you doing to stay ahead of the curve?

Goodwin is a unique CDMO when considering other options in the market. As a smaller, client-focused organization, we are able to cater to each client’s needs whereby quality, timeline, and budget targets are optimized. The current market landscape is primarily controlled by larger organizations that are burdened with the logistical complications of being spread out across the globe with multiple service channels which increases complexity, costs and delivery risk.

We work closely with our client partners to understand their future paths. We leverage this relationship to expand our capabilities so that we can continue to support them for the life of their product.

Q. How do you plan to transform your company into a future that is unfolding before you?

Currently, Goodwin is in the midst of a major expansion that will increase its capacity and efficiently meet regulatory compliance. Its new and increased Fill & Finish capacity, will enhance its current filling capacity by a factor of four and will also support late-stage clinical and commercial product manufacturing. At the same time, Goodwin is aligning and expanding its manufacturing capacity from 500L to 2,000L single-use bioreactors, which will be in place in 2022. Also importantly, Goodwin’s regulatory compliance, Quality Systems and other business systems are continually being expanded and upgraded, with an eye to supporting our much-increased business scale in the very near future.

About | Karl Pinto

Karl Pinto serves as the Chief Executive Officer of Goodwin Biotechnology, Inc. He is an entrepreneurial, seasoned executive whose career spans over 28 years in executive management and international business development in the USA and Asia.

“Our platform Single Source Solution™ provides our clients with unique access to a partner that can take their product from proof of concept all the way to a vialed drug product that is commercially viable, all under one roof.”