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Manufacturing

Service

Ajinomoto CELLiST Korea is equipped with large-scale production facilities and management systems in compliance with the current Good Manufacturing Practice (cGMP). We provide customized manufacturing services of various powder formulations according to customers’ needs, from specifically-customized amino acid mixture supplements to bulk production of commercial growth and feed media.

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What We Can Offer

  • Flexible small to large scale media or supplement production
  • Provide prototype media or supplement usually in 10 business days after order in a non-GMP environment
  • Provide media or supplement usually in 6-12 weeks after order in a cGMP environment
  • Offer competitive price

Overall Process

Supported Items

Powder Media/Supplement: powder lots to 10 kg (non-GMP), to 1,000kg (cGMP)

Container (L) 5L 10L 20L 80L 250L 1,000L 2,000L
non-GMP ~2kg ~5kg ~10kg
cGMP ~10kg ~50kg ~100kg ~450kg ~1,000kg

Annual maximum production capacity: 200 ton (1 ton x 200 batches)

Various kinds of formulas includes:
      Customer-developed formulas       Classical formulas with or without modifications (e.g. DMEM with low NaCl)

Media are packaged in aluminum pouch or plastic pail by weight

Aluminum pouch 6L Plastic drum 20L Plastic drum 60L Plastic drum
Amount(kg) ~0.050kg ~3kg ~10kg ~20kg
Amount(L) ~1L ~50L ~500L ~1,000L

Quality Control Testing

Product quality are evaluated by the following tests

  • Appearance (powder, after dissolving)
  • Loss on drying
  • pH (after dissolving)
  • Osmotic pressure (after dissolving)
  • Cell culture test
  • Endotoxin test
  • Microbial limit testing (TAMC: NMT 100cfu/g, TYMC: NMT 20cfu/g)
  • Mycoplasma

Result of Analysis is available for prototype.

Testing includes Appearance, Solubility, pH and Osmolality.
TAMC/TYMC, Endotoxin, Mycoplasma and Cell culture are optional, requiring more lead-time to the delivery.

Manufacturing Flow

Weighing is a process to measure the designated ingredients precisely with appropriate scales, which are periodically calibrated.
Pulverizing is a process to make uniform and stablesize of particles. Use specific pulverizer/mill for pulverizing process based on the characteristics of ingredient (e.g. trace elements) and scale of production. Mixing processis crucial for ensuring uniformity of intermediate products. According to characteristics of ingredients and to production scales, separated pre-mixing procedures are employed in the overall process.
Sieving process is a technique for prevention of foreign material contamination according to size. 2 mm- and 1 mm- sized sieves are used sequentially.
Final mixing is a process to assure the uniformity of products.
Packaging is done according to the requested quantity and packaging volumes, by using automatic filling equipment. Also labelling is proceeded.
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