cGMP Manufacturing Services
The challenge of finding a partner to support your cGMP manufacturing solutions is overcome through Goodwin’s integrated range of services as illustrated in the following:
Single Source Solution™
This Single Source Solution™ includes a broad array of biologics manufacturing services such as Analytical Method Development, Cell Banking, Process Development, clinical cGMP Contract Manufacturing, as well as Purification, Bioconjugation, and Aseptic Fill and Finish– All with the requisite Regulatory and CMC Support.
Goodwin Biotechnology offers you a full array cell banking services for research or manufacturing use. Manufacturing banks include seed, master, working, and post production. All of these banks are GMP compliant and are tested based on the current Points to Consider for cell bank testing. Goodwin works closely with our clients and with our qualified contract testing organizations to assure acceptability of all testing. Banks are prepared using a controlled freeze rate system and are stored in the vapor phase of liquid nitrogen (-196 C) in cryogenic storage chambers. All bank inventories are secured and controlled by Goodwin Biotechnology’s Quality department. Short- or long-term storage of cell banks is provided.
- Research Cell Bank – Research cell banks can be made at Goodwin Biotechnology to carry out non-GMP process development activities.
- GMP (Master and Working Cell Banks) – Goodwin Biotechnology produces Master Cell Banks (MCBs) and Working Cell Banks (WCBs) in compliance with cGMP requirements.
Goodwin Biotechnology will manufacture cGMP material for you using:
- Stainless steel, stirred tanks, 200L and 500L
- 50L disposable WAVE bioreactors
- 200L Single-Use Bioreactor (with 500L and 2,000L SUB available in second half of 2021)
- XCell™ ATF 6 System for Perfusion, Fibracell disk immobilized bed perfusion bioreactors, which provides10,000 Liters or more of cell culture harvest in a small footprint.
The scale of the bioreactor selected depends on the productivity of the cell line and the requirement for GMP material. Once the GMP material is produced, Goodwin Biotechnology performs in-process and release testing as well as QA review of the GMP manufacturing documentation. In addition, Goodwin Biotechnology offers stability studies, viral clearance studies, and creation of a reference standard to meet regulatory compliance needs.
Meet the Upstream cGMP Manufacturing Technical Leadership
Profile of
Andrew Majdoch
Associate Vice President, Technical Operations
Andrew has over 20 years of experience in manufacturing biologics and biopharmaceuticals. Prior to joining Goodwin Biotechnology, Andrew was the Senior Manager – Clinical Manufacturing and Process Development at Alkermes plc where he worked for 13 years in manufacturing (commercial and clinical) and process development. Andrew has experience developing drug candidates in the large molecule design space focusing on recombinant therapeutic proteins. Andrew began his career with Abbott Laboratories where he worked for 7 years moving up through the ranks to become the Rare Reagents Manufacturing Supervisor overseeing the mAb production suite. At Goodwin, Andrew is responsible for all manufacturing operations including GMP and non-GMP upstream and downstream manufacturing as well as associated support activities such as Fill / Finish. Andrew earned his Master’s of Science degree in Engineering and Technology Management from Oklahoma State University and a Bachelor’s of Science degree in Biology from the University of Wisconsin.
cGMP Purification Manufacturing Services
As the product proceeds through its clinical evaluation, Goodwin Biotechnology conducts a Pre Performance Qualification (PPQ) by developing and optimizing the purification process including the testing and establishment of parameter limits. When the product reaches Phase III clinical testing, Goodwin Biotechnology will have developed a fully characterized process that can be transferred for commercial manufacturing and ready for qualification (PPQ) runs in Goodwin’s new commercial facility.
- Develop product quality, process economics, and scalability
- Resin-reuse (e.g., Protein A column)
- Product safety and compliant (e.g., viral inactivation and removal)
Goodwin has extensive experience with an array of purification capabilities to meet your cGMP production needs. Purification suites at Goodwin are segregated and customized with equipment to specifically meet the requirements of each client process in a campaign mode. Purification personnel are experts with multiple chromatography and purification techniques including the use of the ÄKTA process 10mm Skid with gradient function capabilities and ÄKTAready for process scale up, through to large scale processing of operating flow rate of up to 500-600L/h of clarified harvest feed stream, tangential flow filtration and bulk drug substance filling. Viral clearance studies are managed by Goodwin Biotechnology using a contract biological safety testing organization. Viral Clearance Studies for early stage clinical trials require two model viruses. For late stage clinical trials, four model viruses are required.
Goodwin Biotechnology can perform the necessary scale down validation to assure that the process transferred to the testing organization is representative of the full-scale process. Goodwin Biotechnology can provide an onsite scientist at the testing organization to assure that your process is run according to its requirements to avoid comparability questions on the results. The scale-down validation and viral clearance studies are assembled into one package for submission to regulatory agencies or other manufacturers.
Meet the Downstream cGMP Manufacturing Technical Leadership
Profile of
Garth Cole, MBA
Senior Manager, Downstream Manufacturing Operations
Garth has over 25 years of experience in biopharmaceutical manufacturing focusing on managing downstream purification departments at companies such as Baxter Bioscience, Amgen, and Lonza where he has managed, trained, and coached purification teams in purifying commercial and clinical products to satisfy production objectives. Over the last 3 years, he has managed the Downstream Manufacturing Operations at Goodwin Biotechnology. Garth earned his MBA at the Keller Graduate School of Management and a Bachelor’s degree in Technical Management at DeVry University.
What Clients Say about Goodwin’s cGMP Manufacturing Services
Goodwin has significant experience in working with companies like ours and the capabilities to provide the scale-up needed for a late-stage clinical trial. Goodwin’s competencies in process and product implementation, quality assurance, and GMP manufacturing make it ideally suited as a manufacturing partner for Actinium as we look forward to launching this pivotal phase 3 trial later this year.
cGMP Manufacturing – Bioconjugation
Whether the conjugate is a Class III or lower drug toxin (small molecule cancer drugs, plant protein toxins), chelating agents for radio isotopes labeling (diagnostics and therapeutics), adjuvants such as Aluminum Hydroxide-Antibody drug conjugate, or other antibodies, Goodwin has the ability to develop and perform them at GMP compliant manufacturing scales for clinical applications. In fact Goodwin’s fully integrated solution is positioned to support the life cycle of developing to cGMP manufacturing of the bioconjugate.
The development group fully understands the issues involved with these processes such as incorporation levels, active site masking and isotope uptake and stability. The manufacturing group has utilized these processes in the production of multi-gram lots of conjugated antibodies that have been administered in clinical trials throughout the world. Goodwin has both the expertise and experience in protein modification utilizing either chemical conjugation or enzymatic digestion. Antibody modification through enzyme digestion is another Goodwin staff specialty. The production of Fab and F(ab’)2 fragments and their subsequent purification can be achieved to a client’s specifications. These processes are GMP compliant and scalable to multi-gram lot sizes for clinical applications.
What Clients Say about Goodwin’s cGMP Phase III Bioconjugation Manufacturing
Vendor selection is important to product development and as such we have selected Goodwin for manufacturing scale-up because of their track-record in antibody conjugation, including radiopharmaceuticals.
Goodwin’s Experience with Late Stage Clinical Manufacturing
Over the past 28 years, Goodwin has had the privilege of cultivating long term client trust that has facilitated our journey from early stage to late stage clinical manufacturing.
