cGMP Manufacturing

Diosynth Biotechnology is a leading provider of cGMP manufacturing services to the biotechnology and biopharma industries.

Manufacturing Strengths People 1

Exceptional performance, meeting start and delivery times
Experience in clinical and commercial production
Technical excellence
Full compliant with both current Good Manufacturing Practices (cGMP) and with environmental, health and safety regulations

Our projects have included:

Tech Transfer to manufacturing from internal process development and from external transfer
Production of recombinant proteins/peptides for therapeutic applications
Production of recombinant vaccines

Our capabilities include manufacturing using mammalian, insect, and microbial expression systems.

We have considerable expertise in producing products from a wide range of cell types including:

CHO
NS0
SP2/0
hybridoma
E. coli
Pichia pastoris
Baculovirus Expression (Sf 9, Sf 21)

Our facilities produce products for pre-clinical, clinical, and commercial supply.

Fermentation

(140 L and 2,000 L)
(7,400 L and 14,000 L)

Cell culture

(110 L and 2,000 L)
(650 L perfusion and 25,000 L)

We employ both fed-batch and perfusion production technologies at working volume scales ranging from 14-L to 25,000-L (25m³) and our corresponding recovery and purification suites operate a wide range of recovery, high and low pressure chromatography, and filtration techniques.

Our facilities have an excellent record of regulatory compliance and have hosted inspections from the FDA, EMEA and other global regulatory authorities.

We are experts in the operation of multi-product facilities and have a long track record of efficient execution of cGMP manufacturing campaigns.

See also