Lot & Final Drug Product Release Testing

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판매자: Charles River
브랜드: Charles River

Lot & Final Drug Product Release Testing

To ensure that client biopharmaceuticals, pharmaceuticals and medical devices are produced according to the strict requirements of Good Manufacturing Practice (GMP) and that the release testing packages are carefully designed to demonstrate that compliance, we provide a full range of product release support, from addressing biosafety concerns and analyzing potency using suitable bioassays, to determining purity and other biochemical characteristics. Our commitment to providing rapid turnaround times for all testing helps minimize the period between production and release.

GMP Release Testing Services

Charles River provides release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets, and can act as a single site for your global release testing.

Submit a Sample

Our highly experienced team is committed to successful long-term relationships with our product release clients. We have gained valuable experience over the past 15 years generating data in support of more than 8,000 batches of various protein and small molecule products. Each year, we perform full specification release tests on over 500 batches of 22 final products and single tests on many more. We work closely with operational staff, offering flexibility to meet clients' manufacturing schedules.

Typical Release Testing Program

Identity Potency Purity & Impurities Physicochemical Properties Presentation Attributes Microbiology
SDS-PAGE with western blot or CE-SDS Cell-based potency assays Residual DNA/host cell protein pH determination Visual assessment Sterility testing
Isoform analysis (IEF, C-IEF) In vivo potency Size-exclusion HPLC of proteins Osmolality determination Determination of volume in syringes and vials Microbiology assays
Protein characterization Cation-exchange HPLC of proteins Determination of excipient levels LAL/monocyte activation test, in vivo pyrogenicity
Binding assays Reverse-phase (RP) HPLC of proteins General safety/ abnormal toxicity
CE-SDS, C-IEF

EU Release

All marketed products or investigational medicinal products (IMPs) manufactured outside the EU require re-testing at an EU-based facility. We can provide this service through our local European facilities. Testing programs may include differing combinations of microbial testing, biochemical analysis, purity, safety and potency testing, as required by the regulatory authority for market entry.

Technology Transfer

Controlled management of technology transfer is key to the efficient establishment of an effective lot release program at a contract research organization. Our team initiates discussions with clients regarding their methods at the earliest stages, and carefully studies how their process is actually conducted. This approach allows us to transfer and establish client methods at our facility in the shortest timeline, and maintain control of these methods throughout the life of the product. Our experience with technology transfer, our focus on communication and our rigorous generation of documentation and study performance enables us to support the client in the most effective and timely manner possible.


배송/결제/교환/반품 안내

배송 정보

기본 배송비
  • - 3,300원 (배송비 3,000원 + 부가세 300원)
  • - 10만원 이상 구매시 배송비 무료
  • - 도서산간 및 제주를 포함한 일부 지역 추가비용 발생
교환/반품 배송비
  • - 상품 별로 상이
착불 배송비
  • - 착불 적용 상품에 개별 부과 (상품 별로 상이)
  • - 착불 상품의 경우 판매처마다 배송을 할 수 있기 때문에 중복으로 착불비가 발생 가능
  • - 일반 상품과 함께 구매하더라도 해당 판매업체의 구매 금액에 따라 착불 배송비 발생 가능
교환/반품 배송비
  • - 상품 별로 상이

결제 및 환불 안내

결제 방법
  • - 신용카드
  • - 실시간 계좌이체
  • - 연구비카드 결제 (결제링크 이메일 전송)
  • - 무통장 입금 (기업은행 033-502993-01-019)
취소
  • - 취소 접수 후 3 ~ 5일 이내 환불 처리
반품
  • - 반품 접수 후 3 ~ 5일 이내 환불 처리
환급
  • - 회사는 회원이 구매신청한 상품 등이 품절 등의 사유로 인도 또는 제공할 수 없을 때에는 지체 없이 그 사유를 회원에게 통지하고,
      사전에 상품 등의 대금을 받은 경우에는 대금을 받은 날로부터 3영업일 이내에 환급하거나 환급에 필요한 조치를 취합니다.

교환 및 반품 접수

교환 및 반품 접수 기한
  • - 상품 수령일로부터 7일 이내
교환 및 반품 접수가 가능한 경우
  • - 제품의 하자는 없지만, 다른 상품으로 교환하거나 반품 원하는 경우
     (배송비 고객 부담)
  • - 상품자체 불량 및 하자에 의한 경우
  • - 상품 오배송에 의한 경우
교환 및 반품 접수가 불가능한 경우
  • - 상품 수령 후 7일을 초과한 경우
  • - 개별 포장 상품의 포장을 훼손한 경우
  • - 고객의 고의적인 귀책으로 상품가치가 훼손된 경우
  • - 주문제작을 통해서 제품을 생산하는 경우
  • - 주문 당시 재고가 없어서 해외를 통해 제품을 수입해서 구매하는 경우

교환 및 반품 신청

교환 절차
  • - 상품 불량/오배송/상품파손
  • - 전화(02-585-1342) 또는 info@cacheby.com에 상품교환 접수
반품 절차
  • - 반품할 품목을 확인 후 info@cacheby.com로 반품 신청 (수령 후 7일 이내 가능하며 이후 불가)
  • - 전달드린 주문번호와 함께 반품 상품을 포장
     (포장을 꼼꼼하게 해주셔야 반품 상품 손상에 따른 불이익이 없습니다.)
  • - 택배회사 방문 시 반품 상품 전달
     (택배사의 반송장은 상품 교환이 완료될 때까지 보관해주시기 바랍니다.)

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