Manufacturing Manufacturing
Manufacturing

(+86) 0512-8391 9850

Fully validated & GMP compliant large-scale cell culture media manufacturing facility
280*480
01
Experienced process development & manufacturing team

(1)Process development & scale-up for more than 200 dry powder media formulations
(2)Manufacturing team with in average 8 years of on-site GMP management experience in the pharmaceutical industry;
(3) Rich experience in dry powder production technologies such as needle milling, hammer milling, one-step granulation, dry granulation, lyophilization, etc.

02
Operational continuity

(1) GMP-compliant facilities and utilities;
(2) Strict risk control policy, based on QbD principle to minimize contamination and cross-contamination while ensuring regulatory compliance;
(3) Compliant software systems, including digital warehousing and digital dosing systems, to achieve process quality assurance, traceability and operational efficiency

03
Stable & sufficient capacity

(1) GMP batch size: dry powder 1~2000 KG, liquid 1~2000 L
(2) Customizable batch size, delivery time & quality requirement;
(3) systematic confidentiality management to ensure media recipe security

04
Advanced process technologies

Dry powder processing
1) Granularity analysis, powder property analysis, tunneling electron microscopy, etc;
2) Lot-to-lot consistency & intra-lot homogeneity by rational process design;
3) Unique liposome process technologies
Liquid processing
1) Fully closed & single-use system to eliminate cross contamination;
2) Ready-to-use sterile liquid solutions with flexible sizes and packaging to meet various needs of the pharmaceutical industry

Experienced process development & manufacturing team
Operational continuity
Stable & sufficient capacity
Advanced process technologies
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8000㎡ of GMP manufacturing facility

2000㎡ clean room, including Class D (ISO 8) and Class C (ISO 7) area;400㎡ R&D Lab; Biosafety level 2 (BSL-2) Lab

Large-scale dry powder media and liquid media capacity

Powder media (Class D area)
Batch size: 1~2000 KG (50L~100,000L),Max: 20,000,000 L / year
Liquid media (Class C+A area):
Batch size: 2000 L,Max: 400,000 L / year

Media development capacity

8-10 projects / year