(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.
(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
(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
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