Contract
Manufacturing

Service

Ajinomoto CELLiST Korea具备基于优秀医药品生产及质量管理标准(cGMP)的生产设备和管理体系。我们根据客户的要求,从工艺特殊的氨基酸混合物到商业生产用培养基及补料产品,提供多种粉末剂型产品的生产服务。

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.

生产流程

从毫克到公斤,使用通过校验的称量设备,准确称量指定的原料。
为了得到均匀而稳定的粒度而实施粉碎。 使用微粉碎机均匀粉碎产品原料。 根据生产规模进行捣碎混合,以保证混合均匀。 根据原料的特点和生产规模,在整个生产过程中采用了分离的预混合工序。
以1毫米、2毫米规格进行过筛,以防止异物混入。
最终混合已完成过筛工序的原料。
利用自动填充设备按要求数量进行包装并贴标签。
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