What is a Biopharmaceutical CDMO?

A Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) also known as a Contract Manufacturing Organization (CMO), is a company that serves others in the pharma and biologics industry by providing services on a contract basis from development of a process for the candidate biologic molecule through to cGMP manufacturing.

cdmo pharma

This enables biopharmaceutical companies to outsource those aspects of the business, which can help with process development in an effort to generate a manufacturing process that can be efficiently scaled up economically and compliant in order to meet the needs of early- and late-stage clinical trials, as well as licensed manufacturing of the marketed product.

A CDMO helps partner companies to derisk the development and manufacturing process economically through the utilization of of highly skilled and experienced scientists from the CDMO. Working with a CDMO also limits the financial risk of the biopharmaceutical company by eliminating the need to build and staff dedicated manufacturing facilities for candidate drugs that may or may not become successful marketed products.

Bio pharmaceutical CDMOs typically offer services such as upstream and downstream process development, stability studies, method development, protein characterization, reference standard creation, scale-up, cGMP manufacturing and aseptic Fill Finish of pre-clinical and clinical supply material for early- and late-stage clinical trials as well as registration batches and commercial production. Overall, it is critical that a CDMO is operated in a highly regulated environment and complies with current Good Manufacturing Practices (cGMP) that are based on the demands of regulatory bodies such as the Food and Drug Administration (FDA) and European Union (EU) regulatory agencies and other regulatory agencies world wide.

In recent years, the concept of a comprehensive single-source provider from drug development through commercial manufacturing has become popular and valuable primarily because of the complexity of transferring manufacturing processes from one facility to another and the costs associated with changing providers. The best-positioned CDMO pharma service provider offers a significant level of experience in biological and promotes end-to-end continuity, efficiency, cost effective and timely project completion for their customers who elect to outsource.

Biopharmaceutical Contract Development and Manufacturing from Goodwin Biotechnology

Since 1992, Goodwin Biotechnology, Inc. (Goodwin) has been a uniquely qualified and flexible, US‐based Contract Development and Manufacturing Organization (CDMO) that offers a Single Source Solution to enhance the value of complex biopharmaceuticals for its clients. Based on this experience as an independent, fully integrated CDMO, Goodwin has partnered with clients from cell line development (with strategic partners), exploratory proof-of-concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, multi-specific antibodies, fusion and recombinant proteins, exosomes, and since 2002, Biologic Drug Conjugates including Antibody Drug Conjugates (ADCs) and vaccine conjugates for early- and late-stage clinical trials. Further, Goodwin will be completing a commercial expansion leveraging a growth capital fund raise that is slated for completion in 2023.

By working with Goodwin, clients can enhance the value of their product candidates with clear process development and manufacturing strategies, as well as a road map to meet the appropriate quality requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients’ lives. Goodwin has worked as a strategic partner with companies worldwide of all sizes from small university spin-offs to major research institutes, government agencies, virtual, small and large, established and multi-national biopharmaceutical firms.

Based on the impressive track record, Goodwin has received numerous industry awards for over a decade that span from the Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News to most recently recognized by PharmaTech Outlook as one of the Top 10 CMOs to watch in 2021.

The Mission Of Goodwin Biotechnology

Goodwin Biotechnology eliminates the manufacturing risk for companies developing complex biologic therapeutics by being the pre-eminent provider of high-quality, cost-effective, flexible and timely cGMP-compliant manufacturing solutions, from pre-clinical development through commercial product supply.

In the biologics CDMO pharma niche, Goodwin Biotechnology was the first to engineer the concept of “full integration”, which enables them to work with clients from Proof of Concept through the manufacture of preclinical and clinical trial products. It is a process termed “GMPnization”. In other words, Goodwin begins every project with the end product/process in mind. Regardless of whether a client is working on a proof-of-concept project or needs a partner to manufacture material for clinical studies, Goodwin employs cGMP quality from the initial production step of developing the genetically engineered “production” cell line all the way through scale up and vialing of the final pharmaceutical drug product.

Goodwin has an enviable reputation for regulatory compliance and, throughout our history, they have provided superior service for their clients that not only meets, but exceeds their expectations. Goodwin looks forward to helping clients realize the promise of their protein!

Why Goodwin Biotechnology?

Goodwin recognizes that one cannot understate the importance of selecting the right Contract Development and Manufacturing Organization (CDMO), because biologics manufacturing is a technologically complex, yet highly regulated process. Large complex protein structures are sometimes fragile and labile and have a low tolerance for error. The best product can fall short or even fail if it experiences substantial delays in the development and manufacturing processes, and the slightest delay can lead to high opportunity costs from lost sales.

Goodwin understands these issues and truly respects the significance of a client’s decision, first to outsource, then to select the best CDMO which can have huge implications of the future success of the organization.

Selection criteria for consideration in selecting a CDMO:

CDMO Pharma Experience

Goodwin Biotechnology has 30 years of experience as an independent contract development and manufacturing organization (CDMO) and 20 years in pioneering Antibody Drug Conjugates (ADCs) including participation in the filing of over 50 INDs.

Delivering On Time

The expertise of highly skilled scientists have proven time and time again to provide solutions by anticipating and addressing challenges before they occur. This, coupled with our project management transparency and efficiencies, help ensure that timelines are maintained.

Delivering On Budget

Goodwin has expertise with over 150 clients and almost 500 different biologic projects assures the delivery a client’s project on time and on budget with no surprises!

Plus, The Value of Flexibility and Trust

It is imperative that your CDMO pharma partner needs to be flexible and trustworthy. One constant in cell culture manufacturing of biologics is certain level of potential change in the product profile and/or process. Therefore, a valuable consideration is to select a strategic partner who can anticipate the unexpected and proactively develop plans to address, or at least rapidly and cost-effectively overcome the challenges. At Goodwin Biotechnology, our staff has not only learned flexibility, but they honed their skills with over 200 years of industry experience combined.

Recognizing the challenges of manufacturing complex biopharmaceuticals, Goodwin Biotechnology stands ready to help formulate a customized strategic approach to your project with an emphasis on critical and key process parameters during process development and manufacturing, assessing critical quality attributes and regulatory considerations.

CDMO Pharma Single Source Solution for Biologics Contract Manufacturing

Goodwin offers a Single Source Solution with a full range of mammalian cell culture process development and cGMP manufacturing services that include the creation of upstream and downstream processes sufficient for the manufacturing of proof of concept or toxicology product material to processes for licensed biopharmaceutical manufacturing.

Goodwin occupies one facility of over 38,000 sq. ft. that is designed and utilized for process development, scale-up, cGMP manufacturing, as well as QA and QC labs and support services. Manufacturing equipment are monitored 24-hour via a computer controlled alarm system. Goodwin is equipped with emergency backup generators in the event of a power loss. Goodwin has a facility staff on site to aid in monitoring and maintenance of manufacturing equipment and its associated utilities.

The challenge of finding a partner to support cell culture manufacturing solutions is overcome through Goodwin’s fully integrated range of services:

Cell Line Development with Strategic Partners

GMP Cell Banking

Analytical Method Development

Antibody and Biologics Characterization Services

Clinical cGMP Manufacturing

Upstream Cell Culture

Downstream Purification

Bioconjugation

Stability Testing

Aseptic Fill / Finish

Services and Support Solutions

Goodwin offers a full range of Services that support the creation of upstream and downstream processes and IND enabling activities sufficient for the manufacturing of proof of concept or toxicology product material to GMP Process Development services for licensed manufacturing.

Goodwin also Delivers Unique Antibody Applications and Other Solutions

Goodwin has many highly skilled scientists who thrive on challenges that, when solved, may develop into a biopharmaceutical candidate that addresses a significantly unmet clinical need.

Learn how to enhance the value of your biopharmaceutical candidate and deliver the promise of your protein. Contact Goodwin Bio to discuss your biopharma project and CDMO pharma needs.

About the Author
Dr. Muctarr Sesay, Ph.D.
Dr. Sesay is the Chief Scientific Officer of Goodwin and has been with the company for 20 years.