生物加工重组补充剂

我们种类繁多的细胞培养辅料系列,其设计宗旨只有一个:助力您的成功。全球各地的生物制药公司都依赖我们的产品来满足细胞培养过程的基本营养需求,因为他们深知,凭借我们的优质产品和专业技术,不仅能帮助他们提高生产效率和稳定性,还能有效降低风险。
重组生长因子和转运蛋白
我们所有的重组、非动物来源(NAO)培养辅料均专为细胞培养应用而特别配制。在最先进的cGMP生产设施中进行的重组生产,不仅确保了可靠且稳定的供应,同时也简化了监管流程。您将找到行业领先的重组培养辅料和工艺酶产品系列,以满足您的特定应用需求,包括:
补充剂
- CellPrime® rAlbumin——非常适合培养基的开发、优化或补充,可作为人/牛血清白蛋白的无动物源替代品,消除血液衍生蛋白质带来的变异性,并防止意外病毒或朊病毒污染。
- CellPrime® rTransferrin——常与重组白蛋白和重组胰岛素配合使用,作为细胞培养基配方中的补充剂混合物来替代血清转铁蛋白。CellPrime® rTransferrin 消除了血液来源蛋白质带来的变异性,并防止意外病毒或朊病毒污染。
- CellPrime® rInsulin——该非动物源性(NAO)补充剂在延长各种细胞系长期存活能力的同时,还能促进细胞生长和蛋白质生产,常用于单克隆抗体(mAbs)、病毒疫苗和干细胞扩增的上游工艺。
工艺酶
- CellPrime® rTrypsin——用于在疫苗生产过程中收获时分离和重悬贴壁细胞,也可用于干细胞培养,在剥离生长在载体上的贴壁细胞的同时,保持细胞表面标志物的结构和功能完整性。其他应用包括重组胰岛素制造和一般生命科学细胞培养。
- CellPrime® rTrypsin STD——作为 CellPrime® rTrypsin 的配套产品,其放行标准符合《美国药典》(USP 43,2013)中关于结晶胰蛋白酶的规定。其比活性以 BAEE 为底物测定,对酶的 α 型和 β 型同工酶之间的分布要求较宽松。
- CellPrime® rLysozome——比动物源酶更有效,CellPrime® rLysozome 可在成本相当的情况下,更便捷、更温和地裂解细菌细胞,同时具备非动物源的安全特性。
其他补充剂
作为我们全面产品组合的一部分,我们还提供动物源性细胞培养辅料,这些产品被广泛应用于全球诊断领域及众多商业生物制药产品中。尽管从生物加工的角度来看,哺乳动物细胞的操作可能颇具挑战,但凭借我们的丰富经验和严格的产品质量控制,可助您从容应对复杂的加工和规模化生产参数。
此外,我们还生产多种适用于特定细胞培养和体外诊断(IVD)应用的配套产品。例如,牛转铁蛋白、EX-CYTE® 和牛γ球蛋白等产品,均经过专门设计和生产,旨在满足受监管环境下客户对质量和文件记录的要求。
相关文件
- Data Sheet: CellPrime® rAlbumin
CellPrime® rAlbumin is a GMP-manufactured, non-animal origin (NAO) recombinant media supplement, ensuring excellent quality, superior performance, and lot-to-lot consistency. It is expressed from a synthetic DNA insert encoding the human albumin gene sequence in the yeast Pichia pastoris, and like all recombinant CellPrime® products, it does not contain components of animal or human origin throughout its manufacturing process.
- Data Sheet: 4512 CellPrime® rInsulin
Insulin plays a critical role in mammalian cell culture biomanufacturing, enhancing cell growth, protein production, and long-term viability of various cell lines. It is a pivotal component in upstream media formulations for the production of monoclonal antibody therapeutics, viral vaccines, and various recombinant biomolecules such as coagulation factors.
- Data Sheet: CellPrime® rTrypsin
Pancreatic trypsin, a ~23 kD serine protease, has been crucial in stem cell propagation, vaccine manufacturing, and precursor maturation in therapeutic recombinant insulin production as a dissociation agent and manufacturing aid. It specifically cleaves the peptide backbone after arginine or lysine residues.
- Data Sheet: CellPrime® rTrypsin Recombinant Trypsin for Stem Cell Manufacturing
A proprietary recombinant trypsin alternative has been added to the CellPrime® portfolio to meet the increased market demand for non-animal origin cell culture reagents, ensuring a safe and sustainable supply for stem cell propagation and addressing the risk of introducing adventitious viral agents into the manufacturing process.
- Product Sheet: CellPrime® rTrypsin Recombinant trypsin
CellPrime® rTrypsin is a non-animal origin product, recombinantly expressed from a synthetic DNA construct encoding the porcine gene sequence in the yeast Pichia pastoris. It does not contain components of animal origin throughout its manufacturing process, from the Master Cell Bank (MCB) and Working Cell Bank (WCB) to the final product.
- Data Sheet: CellPrime® rTransferrin Data Sheet
CellPrime® rTransferrin AF is designed for industrial cell culture applications, aiming to facilitate extracellular iron binding and transport, thereby promoting viability and proliferation in cells grown in serum-free media. It offers the advantages of natural plasma-derived transferrin while ensuring non-animal origin compliance.
- Flyer: One-Stop-Shop Protein Recovery from Inclusion Bodies
The increasing demand for biotherapeutics as well as healthcare cost pressures have spurred an intense search for more cost effective, faster and more efficient alternative expression systems.