GMP Services to Support Commercial Development
Expedite your development with our comprehensive suite of GMP services specifically designed to streamline regulatory and get you to market faster.
Reliable and Consistent Manufacturing
Robust QMS
Products and services are governed by strict adherence to an ISO 13485:2016-certified quality system and GMP guidelines.
Complete GMP Solution
Formulate, test, qualify, validate, and manufacture GMP media and other critical lab solutions — a true end-to-end solution.
Proven Expertise
Receive top-quality support from trained scientists with years of experience in cell culture and the production of liquid laboratory solutions.
GMP Services to Support Your Media Needs From Design to Commercialization
Consistent, GMP-compliant raw materials are crucial as you transition to the clinic. Prepare your cell culture media and critical laboratory solutions for regulatory approvals, scale-up, and downstream manufacturing. With a comprehensive services offering, we can support your transition from development to commercialization.
Accelerate Scale-up and Scale-out
Accelerate your development and path to manufacturing with our Process Development Services. Our solutions support full-scale GMP manufacturing and compliance with global regulation:
- Raw material testing
- Filter scale-up work
- Shelf-life studies
- And more!
Ensure Your Products Meet Quality Demands
Our team of experts can help set you up for success. We can assist with a number of integral qualification and validation processes related to the production and delivery of your product including:
- Establishing fill protocols
- Validation of shipping conditions
- And more!
Streamline and Accelerate Regulatory Compliance
Ensure quality throughout the development and manufacturing process with our Quality and Regulatory Services. Our solutions to help simplify your regulatory processes include:
- Creating manufacturing protocols
- Generating test methods
- Producing batch record documentation
- And more!
Committed to Your Project Goals and Success
State-Of-The-Art Facilities
Our state-of-the-art facilities feature multiple manufacturing sites to support your cell culture needs. Our facilities contain over 7,000 square feet of manufacturing space and are outfitted with a total of 7 cleanrooms to produce liquid and powder media.
Project Management
With a dedicated project manager, we provide a structured and transparent process with regular updates, fast communication, and detailed scopes of work specific to your requirements.
Service Menu
Our robust, defined menu of services is designed to specifically expedite and streamline the most common challenges in testing, qualification, validation, and regulatory considerations that require GMP-quality methods and procedures.
Flexible Solutions
Often, the best items are actually off-menu. With years of expertise in producing GMP-quality laboratory liquids, we can help with almost any project. Bring your requests to us and get a specialized scope of work uniquely crafted for your project and needs.
Let Us Design Your Formula
Formulation of a cell culture media designed specifically to meet your critical attributes should be the first step in your journey to an efficacious GMP therapeutic. At Nucleus Biologics, we are experts in creating media with the qualities important to your cell culture. Learn how our formulation services team can help optimize your media and prepare you for GMP scale-up.
FAQs
Are you limited to the services offered on your menu?
Can you perform process development and validation on products other than cell culture media?
Yes. We have experience with a number of common laboratory solutions from buffers and balanced salts to water for injection (WFI) and Ficoll. Bring your ideas and we will do our best to assist your project.
How many cleanrooms do you have and what classifications are they?
We have a total of 7 cleanrooms — a combination of ISO 7 and ISO 8 — that can manufacture liquid and powder (pods) cell culture media.
Are your Formulation Services and GMP Services complementary or stand alone?
Both. Depending on where you are in your development, we will evaluate needs and recommend services that can include media formulation and optimization. Regardless of your stage of development, we can support your project.