세포치료제 등급 Biolaminin 521 CTG (CT521)

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세포치료제 등급 Biolaminin 521 CTG (CT521)

BIOLAMINA사의 Biolaminin 521 CTG는 세포치료제 등급의 Biolaminin 521입니다. 동물유래 성분이 없고 모든 공정에 대한 추적이 가능하여, 임상 세포치료제 생산시 supplement로 사용할 수 있습니다.

프린트 제품 문의

특징

Biolaminin 521 CTG는 줄기세포의 미세환경을 그대로 구현하는 Biolaminin 521의 세포치료제 등급으로, 임상에 적용되는 세포치료제 생산시 supplement로 이용될 수 있습니다.
ISO9001:2015 quality management system에 맞추어 생산되었습니다.
ISCT Animal-Free Origin Survey Results-Summary 기준에 따라 animal-free secondary level로 , 제조 공정에 사용된 모든 물질은 모두 추적이 가능합니다.
균질하고 유전적으로 안정적인 hPSC 배양에 이용됩니다.
Automation에도 적용할 수 있습니다.
단편화된 라미닌 제품과 달리, full length 라미닌은 integrin, dystroglycans 및 syndecans을 포함한 모든 관련 세포 표면 수용체와 결합할 수 있습니다. 특히, 성장 인자를 포함한 다양한 미세환경 요인과도 상호 작용할 수 있습니다.

Biolaminin 521 LN / MX / CTG 비교

Product name	Biolaminin 521 LN	Biolaminin 521 MX	Biolaminin 521 CTG
Catalog number	LN521	MX521	CT521
Product claims	Research grade	Research grade	Cell therapy grade
Declaration	For research use only	For research use only	For research use or non-commercial manufacturing of cell, gene, or tissue-based products
	Human recombinant laminin 521. A trimeric protein of total 774 kDa (400 kDa, 196 kDa, 178 kDa, respectively).	Human recombinant laminin 521. A trimeric protein of total 774 kDa (400 kDa, 196 kDa, 178 kDa, respectively).	Human recombinant laminin 521. A trimeric protein of total 774 kDa (400 kDa, 196 kDa, 178 kDa, respectively).
Manufacturing	Human, adherent cell line	Human, suspension cell line	Human, suspension cell line
Animal origin-free¹⁾	Primary level*	Secondary level	Secondary level
Quality control	• Appearance (clear colorless solution) • Concentration 0.10 mg/mL • Authenticity • Protein purity • Mycoplasma (PCR) • Endotoxin <50 EU/mL (EndoLISA) • Potency	• Appearance (clear colorless solution) • Concentration 0.10 mg/mL • Authenticity • Protein purity • Mycoplasma (PCR) • Endotoxin <50 EU/mL (EndoLISA) • Potency	• Appearance (clear colorless solution) • Concentration 0.10 mg/mL • Authenticity • Protein purity • Mycoplasma (qPCR)‡ • Endotoxin <10 I.U./mL (LAL Kinetic)‡ • Potency • Retroviral RT activity (Q-PERT)‡ • Virus testing‡
Documentation	CoA & Animal Origin statement (AO)	CoA & Animal Origin Free statement (AOF)	• CoA & AOF statement • Extensive QC report (under CDA)
Formulation	PBS buffered saline, 10% glycerol, 0.02% NaN3, pH 7.2	20mM HEPES, 0.25M NaCl, 10% glycerol, pH 7.5	20mM HEPES, 0.25M NaCl, 10% glycerol, pH 7.5

1) ISCT guidance document “ISCT Animal-Free Origin Survey Results-Summary”

* FBS used in early seeding phase. Due to the dilution effect in the production process, the theoretical proportion of serum left in the final product is <0.2 PPM (parts/million). This value is calculated under the assumption that no serum is lost during the purification process, hence the actual concentration is likely to be considerably lower.

‡ According to European and US Pharmacopoeia standards.

적용 사례

Application note 015: Cell therapy grade Biolaminin 521 CTG (내용보기)
Features of the Biolaminin CTG product designed for clinical use
Application note 022: BioLamina products in research and manufacturing – Biolaminin® matrices for all steps and scales (내용보기)
Clinically adaptable Biolaminin cell adhesion coating for higher yield in bioreactor systems
Application note 018: Large-scale cell production (내용보기)
Clinically adaptable Biolaminin cell adhesion coating for higher yield in bioreactor systems
Application note 020: Efficient gene editing on Biolaminin® 521 substrate (내용보기)
Efficient gene editing on Biolaminin® 521 substrate
Application overview 008: Full-length laminin proteins are crucial for stem cells (내용보기)
Full-length laminins are crucial components in creating the stem cell niche in vivo and in vitro