지원되지 않는 브라우저를 실행하고 있습니다. 브라우저를 업그레이드하세요. 닫기

이메일 구독

Never miss the latest news and offers - subscribe now!

Never miss the latest news and offers - subscribe now!

개인정보 취급 방침 및 쿠키

By browsing this site you accept cookies used to improve and personalize our services and marketing. Learn more about our Data Privacy Policy, including cookies, by clicking the Policy button.

By browsing this site you accept cookies used to improve and personalize our services and marketing. Learn more about our Data Privacy Policy, including cookies, by clicking the Policy button.

Single-Use Technologies In A 1000 Liter Plus Monoclonal Antibody Process

How to confirm that single-use manufacturing is feasible for mAb processes at a 1,000-liter plus scale? Pall helped Rentschler to find the answers.

The Challenge

Rentschler Biotechnologie GmbH, is a contract development and manufacturing organization offering full services in development and production of biopharmaceuticals. Subsequent investments have led to a facility with bioreactor capacities up to 2,500 L and nine state-of-the-art suites for GMP production as well as three GMP filling lines and more than 600 fully trained employees.

 

Those facilities have been successfully used for manufacture of various recombinant biotechnology proteins as well as antibody products for many clients. But Rentschler recognized that introducing single-use SU systems could potentially offer significant benefits over our stainless steel upstream and hybrid systems downstream. Rentschler therefore embarked on a concept study to assess the suitability of its processes for conversion to a complete SU system. Afterward, the company prepared and proceeded with a project plan for implementing a single-use upstream and downstream process for generic antibody manufacture.

 

The Solution

Rentschler’s concept study focused on development of two 1,000-L manufacturing lines in an existing building with fully disposable upstream and downstream unit operations. In 2010, the company successfully implemented a single-use bioprocessing line as part of its development plan. The concept study identified several beneficial features, as listed in the “Single-Use Benefits” box.

 

The concept study showed that many restrictions inherent to stainless steel systems could be removed by replacing them with SU technology. Results also suggested that successful implementation would require reconstructing part of an existing building. Also, many of Rentschler’s clients were specifying disposable technologies. So, it was clear that SU manufacturing systems should be a fundamental part of Rentschler’s business strategy for the future.

 

Existing Process for mAb Manufacture

Rentschler’s SU development program was based on the process diagrammed in Figure 1. With a working capacity of ≤3,000 L, the process was based on a hybrid system using mainly stainless steel, cleanable equipment typically associated with MAb production but some SU components in downstream processing. As a contract manufacturer, Rentschler’s requirement for multiproduct capabilities for each line demand thorough and fully validated CIP/SIP procedures. Those were especially important to eliminate cross-contamination and the need for dedicated lines when processes use media containing animal components in their seed trains.

 

Additional checks were needed for performance and integrity after repeated cleaning and regeneration of reusable components such as ultrafiltration (UF) cassettes, ion- exchange chromatography resins, and virus filters. All these and other factors  were important drivers in evaluating SU technology.

 

Read the full article at:
http://www.bioprocessintl.com/manufacturing/monoclonal-antibodies/implementing-a-fully-disposable-mab-manufacturing-facility-331156/

유전자 치료제를 위한 확장 가능한 (Scale-up) 바이러스 벡터의 업스트림 공정개발

Genethon과 Pall® Biotech가 협력하여 바이러스 벡터 생산 플랫폼으로서 iCELLis® 고정상(Fixed-Bed) 바이오리액터의 장점을 입증했습니다.
Genethon과 Pall® Biotech가 협력하여 바이러스 벡터 생산 플랫폼으로서 iCELLis® 고정상(Fixed-Bed) 바이오리액터의 장점을 입증했습니다.
더 알아보기

크로마토그래피 레진의 활용성 향상

Pall과 CMC Biologics는 다중 컬럼 크로마토그래피 기반 다운스트림 공정을 통해 새로운 길을 개척합니다.
Pall과 CMC Biologics는 다중 컬럼 크로마토그래피 기반 다운스트림 공정을 통해 새로운 길을 개척합니다.
더 알아보기

첨단 여과를 통한 고점도 Blow-Fill-Seal 최적화

제균여과 처리량과 관련하여 어떤 문제를 경험하셨나요? 스페인의 CMO Unolab은 Pall의 PES 멤브레인 필터로 까다로운 문제를 해결했습니다.
제균여과 처리량과 관련하여 어떤 문제를 경험하셨나요? 스페인의 CMO Unolab은 Pall의 PES 멤브레인 필터로 까다로운 문제를 해결했습니다.
더 알아보기

1,000리터 이상 단일클론 항체 (mAb) 공정의 Single-Use 기술

1,000리터 이상 규모의 mAb 공정에서 single-use 방식의 실현 가능성을 어떻게 확인할 수 있을까요? Pall은 Rentschler와 협력하여 해답을 찾았습니다.
1,000리터 이상 규모의 mAb 공정에서 single-use 방식의 실현 가능성을 어떻게 확인할 수 있을까요? Pall은 Rentschler와 협력하여 해답을 찾았습니다.
더 알아보기

컬럼팩킹 (Column Packing) - 예술에서 과학으로

한 다국적 백신 기업은 표준작업절차서(SOP)의 실행과 작업자의 실수가 생산성에 큰 영향을 미친다는 점에 주목했습니다. 62%의 컬럼 패킹 성공률을 더 향상하고 인건비를 절감할 수 있을까요?
한 다국적 백신 기업은 표준작업절차서(SOP)의 실행과 작업자의 실수가 생산성에 큰 영향을 미친다는 점에 주목했습니다. 62%의 컬럼 패킹 성공률을 더 향상하고 인건비를 절감할 수 있을까요?
더 알아보기