Stability Testing

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판매자: Charles River
브랜드: Charles River

Stability Testing

Protein, peptide, vector and plasmid products are particularly sensitive to environmental factors. Charles River performs stability studies to evaluate client biopharmaceutical products under various environmental conditions over a specific timeframe, recommend suitable storage and shipment conditions for drug substances and products, and determine the appropriate shelf life or retest period.

GMP Stability Testing Programs

For more than 20 years, our team has helped clients develop and implement cGMP study plans that fulfill worldwide regulatory requirements. We provide a transparent, controlled and clearly documented course for every study we run, with thorough recordkeeping and reporting during and after study completion.

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Stability Study Design

Our team bases all study designs on the International Conference on Harmonisation (ICH) guidelines Q1A(R2): Stability Testing of New Drug Substances and Products and Q5C: Quality of Biotechnological Products – Stability Testing of Biotechnological/Biological Products. Where possible, we apply bracketing and matrix designs in accordance with ICH document Q1D.

Shelf life is commonly estimated using results from both real-time stability and accelerated stability tests. In real-time stability testing, a product is stored at recommended storage conditions and monitored until it fails product specifications. In accelerated stability testing, a product is stored at elevated stress conditions (e.g., high temperatures and/or humidity). Degradation at the recommended storage conditions can then be predicted using known relationships between the acceleration factor and the degradation rate.

Charles River also supports forced degradation programs with studies that use extreme storage conditions in order to increase the rate of degradation. Due to the non-linear nature of protein degradation kinetics, these studies have limited value in shelf-life prediction for biopharmaceutical products. However, because they provide information on product breakdown and degradation pathways, forced degradation studies are particularly useful in early drug development to improve formulation and assist with the determination of storage conditions to control product stability.

For biopharmaceutical products, long-term stability studies are conducted under the intended storage conditions, with shorter duration studies performed at higher temperatures to support in-use stability and shipping conditions. Lower temperature conditions are often included in the program to provide baseline non-stressed values and to prevent delays if the intended storage condition proves to be unsuitable.

Advanced Analytical Methods

Our team is skilled in a wide range of stability indicating analytical techniques using the latest instrumentation including:

  • 1D and 2D SDS-PAGE
  • Western blot
  • Isoelectric focusing
  • Peptide mapping of proteins and peptides using reverse-phase HPLC with UV and/or mass spectroscopy detection
  • Stability-indicating chromatography (e.g., reverse-phase, size exclusion ion exchange and hydrophobic interaction chromatography)
  • Sulfhydryl analysis
  • N- and O-linked glycosylation/carbohydrate analysis
  • Capillary electrophoresis including cIEF ,CE-SDS and CZE
  • Protein content/concentration
  • Spectrophotometric analysis (e.g., UV-Vis, fluorescence and circular dichroism)
  • Determination of pH, dissolution, appearance and color
  • Formulation-specific testing (e.g., subvisible particulates, moisture content)
  • Total active ingredient determination by ELISA or immuno-ligand assay
  • Potency assays including cell-based, in vivo models, ELISA and binding by SPR
  • Container closure integrity
  • Endotoxin, microbial enumeration and sterility testing

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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