Contamination & Impurity Testing
From preclinical lots through routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of your biologic before it is released for use in animals and humans. The characterization of the purification process and testing for possible impurities are also key parts of the chemistry and manufacturing controls (CMC) section of regulatory filings.
Contamination Detection Assays & Impurity/Residual Testing Services
Charles River offers a portfolio of compendia assays for the detection of mycoplasma and bacterial contaminants and also in vivo, in vitro and biochemical viral detection assays. Our experts can design and develop the appropriate testing plan for your biologic, with a selection of available and customized assays that suit your specific needs.
In support of “quality by design” for any process, testing of residual process impurities is an integral step. We support testing of all process stages for impurities such as residual Protein A, DNA, Tween, IPTG, TRIS, PEI, endotoxin and host cell proteins. In addition to generic methods, we offer transfer or method development and validation for customized, product-specific methods.
|기본 배송비||교환/반품 배송비|
결제 및 환불 안내
교환 및 반품 접수
|교환 및 반품 접수 기한|
|교환 및 반품 접수가 가능한 경우|
|교환 및 반품 접수가 불가능한 경우|
교환 및 반품 신청
Charles River의 다른 상품들
To ensure that client biopharmaceuticals, pharmaceuticals and medical devices are produced according to the strict requirements of Good Manufacturing Practice (GMP)
Protein, peptide, vector and plasmid products are particularly sensitive to environmental factors.
The drive to develop new prophylactic vaccines has resulted from the increase in impact of emerging diseases, bioterrorism and resistance to existing antimicrobials, as well as the apparent increased virulence of some viruses, such as influenza.
Potency determination is necessary for regulatory submission and lot release of all biopharmaceutical products
From preclinical lots through routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of your biologic before it is released for use in animals and humans. The characterization of the purification ...