Request information

First name(Required)

Last name(Required)

Email address(Required)

Phone number

Company name

Country(Required)

Country

State(Required)

State

Message(Required)

Consent

hCaptcha(Required)

This field is for validation purposes and should be left unchanged.

53756

Request a quote

First name(Required)

Last name(Required)

Email address(Required)

Phone number

Company name

Country

State

Message(Required)

Untitled

hCaptcha(Required)

Comments

This field is for validation purposes and should be left unchanged.

5619

Our Commitment to Quality

We are dedicated to manufacturing and delivering top-quality, consistent products and services in order to facilitate the speed of scientific breakthroughs.

Supplier and Raw Material Management

Quality and consistency of our products begin with the initial qualification of critical suppliers and control of raw materials. We develop quality agreements with our suppliers, confirm we have full traceability of our raw material, and actively ensure the resolution of any nonconformance.

Two Scientist Looking at the Computer Monitor stock photo

Electronic QMS

Our quality system documentation is controlled using a software platform that is 21 CFR Part 11 compliant and production processes are executed by trained personnel using approved protocols and reports.

Equipment and Process Control

Critical equipment used for GMP manufacturing goes through standard IQ/OQ/PQ procedures and are routinely scheduled for preventive maintenance and calibration. Production processes are validated with approved protocols and reports.

Quality Manual

Quality Manual is designed to meet the requirements of:

ISO 13485:2016 Medical Devices
Title 21 US CFR Part 820 Medical Devices
ISO 9001: Quality Management Systems
EXCiPACT: Certification Standards for Pharmaceutical Excipient Suppliers (GMP)
EXCiPACT PAMs: Application of EXCiPACT GMP Standards to Pharmaceutical Auxiliary Materials
IPEC: The International Pharmaceutical Excipients Council & Pharmaceutical Quality Group, The Joint GMP Guide
USP <1078>: GMP of Bulk Pharmaceutical Excipients
NSF/IPEC/ANSI 363: GMP for Pharmaceutical Excipients

Certifications

ISO 13485:2016

Nucleus Biologics is ISO 13485:2016 certified for the manufacture and distribution of media for the cell and gene therapy industry.

Download now

ISO 9001:2015

Certified for manufacturing quality control testing, quality assurance, and distribution of media, buffers, and reagents for the cell and gene therapy industry.

Download now

EXCiPACT

Certified for the manufacture, quality control testing, and distribution of cell culture media, human serum albumin, media supplements, buffers, and saline solutions as pharmaceutical excipients and pharmaceutical auxiliary materials (PAMs).

Download now

“As the rapidly growing cell and gene therapy industry matures, we must put tools in the hands of therapy developers that allow them to formulate, order, track, and manufacture media with transparency, quality, therapeutic potency, and cost in mind. We are committed to changing the paradigm.”

David Sheehan, Chief Executive Officer

Our Facility

With multiple manufacturing facilities, we provide a vertically integrated solution from powder processing to complete liquid media manufacturing. Our products are manufactured under GMP or Excipient GMP conditions and governed by strict adherence to ISO 13485, ISO 9001, and EXCiPACT certified quality systems.