반응형 제약 및 의료기기, GMP/제형 및 공정10 바이오시밀러 생산과정 제조공정 by 셀트리온 셀트리온에서 배포한 자료중에 자이오시밀러 생산 과정이 이미지로 간결하고 깔끔하게 잘 정리되어 공유합니다. 사실 바이오시밀러 제조 공정이지만 다른 ATMP(첨단치료 의료제품; 첨단세포의약품)도 공정이 유사한 듯 합니다. 이런저런 국내 자료를 찾아봤는데 이만큼 깔끔하고 간결하게 설명한 자료가 없네요 ㅎㅎㅎ 잘 만들었습니다. 아래 링크에서 다운받으실 수 있습니다. 원본은 아래 링크에서 다운받으실 수 있어요. 링크에서 배포하는 자료 들이, 첨부한 바이오시밀러 생산 공정 이외에도 다른 것들도 내용이 좋아서 관심있는 분들은 한 번 돌아보시면 좋을 듯 합니다. https://www.celltrion.com/ko-kr/science/technology Technology 셀트리온 홈페이지에서 허가기관 사이트로 이동합니.. 2023. 12. 7. 5 STEPS IN A COMMON FOOD, DAIRY, AND BEVERAGE CLEAN-IN-PLACE CYCLE 번역 (CIP 사이클 5단계에 대하여) Clean-in-place: 5 Steps in a Common Food, Dairy, and Beverage CIP… (csidesigns.com) Clean-in-place: 5 Steps in a Common Food, Dairy, and Beverage CIP… Clean-in-place: 5 Steps in a Common Food, Dairy, and Beverage CIP Cycle. This is a comprehensive overview of the Clean-in-place Process for systems. Learn how to ensure product quality and integrity by following the steps outlined in this guide. T.. 2022. 10. 11. (FDA)Oral Solid Dosage Forms Pre/Post Approval Issues (1/94)_내용고형제 승인 전/후 고려사항 www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/oral-solid-dosage-forms-prepost-approval-issues-194 Oral Solid Dosage Forms Pre/Post Approval Issues (1/94) GUIDE TO INSPECTIONS OF ORAL SOLID DOSAGE FORMS PRE/POST APPROVAL ISSUES FOR DEVELOPMENT AND VALIDATION January, 1994 Note: This document is reference material for investigators and other FDA perso.. 2020. 12. 1. ISPE I Wet Granulation Knowledge Brief(습식과립기에 대한 지식 요약, 2016) 번역 ispe.org/pharmaceutical-engineering/ispeak/wet-granulation-knowledge-brief Wet Granulation Knowledge Brief ispe.org 본 문서는 위의 칼럼에 대한 번역입니다.(오역/의역 있음) What is Granulation(과립): Granulation is the process of joining multiple particles or grains together, typically using a binding agent although mechanical force has been used to bond the particle together as well. This brief will provide the reader w.. 2020. 11. 20. PCR, RT-PCR, qPCR, RT-qPCR 차이/다른점 https://www.enzolifesciences.com/science-center/technotes/2017/march/what-are-the-differences-between-pcr-rt-pcr-qpcr-and-rt-qpcr?/ TechNote: What are the differences between PCR, RT-PCR, qPCR, and RT-qPCR? Basic PCR methods have further advanced from simple DNA and RNA detection. Below, we have provided an overview of the different methods of PCR and the reagents we provide at Enzo Life Science.. 2020. 6. 2. Development and Manufacture of Commercial ELISA Kits(ELISA Kit의 공통적인 개발 및 제조) Development and Manufacture of Commercial ELISA Kits The rigorous research and development process and strict manufacturing conditions of commercially produced ELISA kits offer a number of advantages for clinicians and medical research. In Europe, most diagnostic companies operate according to the internationally recognised quality assurance system, ISO13485 and the tests CE marked according to .. 2020. 5. 26. ELISA Development Guide / ELISA 개발 가이드 https://www.creative-diagnostics.com/ELISA-Development-guide.htm ELISA Development Guide - Creative Diagnostics Developing an ELISA An ELISA system consists of 4 technical elements: 1) ELISA plate-coating strategy 2) Antigen resources and Antibody pairs 3) Conjugating/labeling strategy 4) Enzyme and chromogen 1. ELISA Coating Strategy When developing a new ELISA for www.creative-diagnostics.com .. 2020. 5. 26. 연질캡슐 제조 공정(2) (Manufacture of Soft Gelatin Capsules) https://www.pharmapproach.com/manufacture-of-soft-gelatin-capsules/# Manufacture of Soft Gelatin Capsules - Pharmapproach.com Manufacture of soft gelatin capsules: This article provides an overview of the basic components of soft gelatin capsule shell as well as the various meth... www.pharmapproach.com Manufacture of Soft Gelatin Capsules Softgels are manufactured using the following methods 1... 2020. 5. 14. 연질캡슐 제조 공정(How to Make Softgel Capsules: The Complete Guide) 출처: https://www.saintytec.com/how-to-make-softgel-capsules/ How to Make Softgel Capsules: The Complete Guide - SaintyTec Today’s guide will focus on how to make Softgel capsules. It will take you through the Softgel capsules formulation, ingredients, equipment, and other processing procedures, among other critical aspects. By the end of it all, you will not only know how to www.saintytec.com 의역/.. 2020. 5. 12. Nutsche Filter(누체필터) / Filter Dryer 관련 정보(정의, 기능 및 지원설비 기본사항) 위키피디아 Filter Dryer 정의 https://en.wikipedia.org/wiki/Filter_dryer Filter dryer - Wikipedia A filter dryer is a piece of process equipment used during the filtration and drying phase of a pharmaceutical, bio pharmaceutical or chemical process for an active pharmaceutical ingredient (API) or other compounds production. Filter Dryers are designed f en.wikipedia.org A filter dryer is a piece of proce.. 2020. 3. 24. 이전 1 다음 반응형
