The Significance of GMP Manufacturing
Good Manufacturing Practice (GMP) is an aspect of quality assurance consisting of processes, procedures, and documentation. GMP ensures medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use for humans or animals.
A stable and reliable supply of GMP-grade biologics is vitally important to all phases of a product’s lifecycle, including preclinical, phase 1, phase 2, phase 3, and commercial stages.
Keywords: cGMP manufacturing, cGMP production, large-scale production in cGMP facility, biologics manufacturing under cGMP standard, microbial fermentation, bacteria fermentation, yeast fermentation, purification
Application: Biopharmaceutical industry, human medicine, animal medicine, vaccine, recombinant large molecule biologics, biologics, biological reagent
GMP Manufacturing Services of Yaohai Bio-Pharma
GMP Manufacturing Capacity
- 140L, 500L, 1000L, 2000L stainless steel stirred fermenters.
- Corresponding centrifugation, high-pressure homogenization, and low/medium/high-pressure chromatography equipment.
- Quality Control (QC) and Quality Assurance (QA) for drug substance on site.
- Deliverables including all relevant documentation and GMP-grade drug substance supporting Investigational New Drug (IND)/ Clinical Trial Application (CTA) and Biologics License Application (BLA) / Marketing Authorization Application (MAA) filling, clinical study and commercial supply.
Types of Organisms
Bacteria (Escherichia coli)
Yeast (Pichia pastoris, Saccharomyces cerevisiae, Hansenula polymorpha)
Other Microorganisms that require Biosafety Level 1 (BSL-1) or Biosafety Level 2 (BSL-2) laboratories.
Types of Products
Recombinant subunit vaccines, virus-like particle (VLP) vaccines, nanobodies/ single-domain antibodies (sdAbs), antibody fragments, peptides, cytokines, growth factors, enzymes and other proteins, plasmid DNA (pDNA).
Service Details
| Services |
Services Details |
| Technology Transfer |
Document transfer |
Process, formulation, analytical methods, and quality standard |
| Technical and compliance evaluation |
Evaluation of Man-Machine-Material-Method-Environment- Measurement; Evaluation of process, formulation, analytical methods, and quality standards. |
| Technology transfer implementation |
Manufacturing process and analytical transfer |
| Process validation |
1~3 engineering batches to evaluate and confirm the process is robust. |
| Microbial Fermentation |
Confirmation before fermentation |
Evaluation of Man-Machine-Material-Method-Environment- Measurement |
| Preparation of fermentation system |
Preparation of culture medium and solution |
| Seed tank and fermenter sterilization |
| Fermentation manufacturing |
Seed cultivation |
| fed-batch fermentation |
| Induction and cooling |
| Crude Purification |
Confirmation before crude purification |
Evaluation of Man-Machine-Material-Method-Environment - Measurement |
| Manufacturing preparation |
Solution preparation |
| Crude purification of the product |
Collection and concentration of culture supernatant - optional |
| Collection and homogenization/lysis of microbial cells - optional |
| Collection and washing of inclusion body - optional |
| Purification |
Confirmation before purification |
Evaluation of Man-Machine-Material-Method-Environment - Measurement |
| Preparation of filtration and chromatography system |
Buffer solution preparation |
| Filler preconditioning |
| Purification manufacturing |
Inclusion body denaturation and renaturation - optional |
| Ultrafiltration, chromatography, enzyme digestion, modification or conjugation |
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