Company Profile

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Company Profile

1st Chinese cell culture media company supporting the commercialization of Chinese new drug

CelluPro, Ltd., headquartered in Yantai, China, specializes in the development and production of GMP-grade serum-free culture media for mammalian cells, and is committed to providing serum-free culture medium products and professional technical services at all stages from early development to commercial production process.

Beyond delivering premium-quality cell culture media, we offer comprehensive solutions including custom formulation development and contract manufacturing services. Our products outperform market alternatives in quality and technical support, earning acclaim from biopharmaceutical enterprises across China.

First Chinese cell culture media company supporting submissions of U.S. FDA BLA and EU MMA

Supported the commercialization of 2 new drugs

Product titer up to 15g/L

50+ media optimization projects successfully delivered

Production capacity of 20,000 liters per batch

Qualifications & Certificates

EXCiPACT Certification - GMP certification for pharmaceutical excipients (industry-leading quality standard)

In accordance with pharmaceutical cGMP standards:

ISO 13485 - Medical Devices Quality Management System

ISO 9001 - Quality Management System

Global Compliance & Sustainability Commitment:

ISO 14001 - Environmental Management System (ESG commitment)

ISO 22301 - Business Continuity Management System

ISO 45001 - Occupational Health & Safety Management System

EXCiPACT

ISO 9001

ISO 13485

ISO14001

ISO22301

ISO45001

Factory Scale

CelluPro has a cGMP-standard manufacturing facility with stable and sustainable supply capacity. Our internationally advanced automated pin mill production system can achieve a mixing accuracy of one in 100,000, with low-temperature nitrogen protection throughout the process to help ensure the activity of media components and product consistency. The MES system ensures precise feeding of each material.

Our fully automated CIP system uses Water for Injection (WFI) for cleaning and is operated under strict biopharmaceutical manufacturing standards. We have supplied cell culture media for the commercial production of marketed drugs. Our stable and reliable production processes can meet customer requirements for development, scale-up, commercial production, and OEM manufacturing.

Factory & Equipment Display

R&D Capability

Advanced experimental equipment and a highly experienced R&D team provide strong support for technological innovation. The R&D team has more than 10 years of experience in biopharmaceutical process development and cell culture media formulation. The team has extensive expertise in understanding the interactions among media components, cell growth and metabolic characteristics, as well as the productivity and quality of target biologics.

Based on this expertise, CelluPro provides effective custom media development and optimization services. Supported by a highly qualified team, diversified R&D capabilities, and rigorous development processes, CelluPro is committed to developing high-quality cell culture media solutions tailored to customer needs.

Development History

2018

Founded and achieved long-term strategic supply partnership with RemeGen

2019

Business expanded overseas

2020

Powder media production line reached to annual output of 1 million liters

2021

Supported commercialization of 2 new drugs
Passed ISO9001 and ISO13485

2022

Declared as technology SME

2023

Declared as high-tech enterprise

Products filed in FDA DMF

Products supplied in USA market

2024

Strategic cooperation with international medium giants

2025

Leads Development of Industry Standard for Serum-Free Mammalian Cell Culture Medium

2026

Complete regulatory support for U.S. FDA and EU EMA submissions

2026

First Chinese Cell Culture Media Supplier to pass EXCiPACT certificate

Resources

Biotechnology Learning Center

OEM Questionnaire

Support

To gain more bio process information

+86 535 3573 396

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