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We provide 

the Essential Value


We add value of your understanding of regulatory guidance on


Impurity

Extractables and Leachables

CCIT (Container closure Integrity testing)


Also, Saint-Gobain with Tubing and Bag as Single use system

SWISS BASEL, E&L SCHOOL Welcome KOREA CUSTOMER

🌐 Quality by Design Inc. - Your Trusted Partner in E&L Studies 🌐

At Quality by Design Inc., we pride ourselves on being at the forefront of the Extractables and Leachables (E&L) study landscape. Our comprehensive services cover:


🔍 Consultation on the current E&L study approach 

🔬 Critical assessment and evaluation 

📜 Extractables & Leachables study and profiling 

🧪 Identification & Toxicological evaluations 

🛡️ Risk and Safety assessments 

✅ Regulatory Registration support


Key Areas of Expertise:

  • Container closure systems like glass vials, stoppers, and related products.
  • Single-use systems and process contact materials.
  • All types of Medical Devices.

"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:

  • FDA, EMA, CHINA, KOREA, JAPAN, BRASIL, Türkiye(Turkey) and more.

Have an inquiry or need expert advice? 📩 Reach out to us at qbd@qbd.co.kr

For a more in-depth look at what we offer, visit our official website at www.qbd.co.kr

Let's navigate the complexities of E&L together! We look forward to partnering with you. 💼🌟


E&L and Pharmaceutical Regulatory Compliance AI 

의약품 인허가 관련 질문하시고 간단한 답변 받으실 수 있습니다.


E&L seminar webinarWebinar : Toxicological Risk Assessment on Extractables and Leachables

관리자
2024-02-25
조회수 1376

Toxicological Risk Assessment on Extractables and Leachables

Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals


이 Topic 에 대해 관심있으신 분은 아래 링크 로 들어가셔서 이메일  등 간략한 정보 입력하시면, 무료로 시청하실 수 있습니다. 


WATCH NOW >


As part of the Biopharma Webinar series, Dr. J. Susanne Becker, Director of Extractables & Leachables Laboratories at Intertek, and Dr. Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals present a great learning session on strategic approaches to extractables and leachables studies and key factors to be considered in a toxicological risk assessment.






[More detail before watching]

https://biopharmawebinars.com/webinars/toxicological-risk-assessment-on-extractables-and-leachables/


Toxicological Risk Assessment on Extractables and Leachables                                                                                                                                                                                              


                 16th January 2024 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Dr. J. Susanne Becker, Director of Extractables & Leachables Laboratories at Intertek |WATCH FOR FREE                 

To ensure the safety of patients, the toxicological risk assessment needs to thoroughly evaluate all potential risks that may be caused by any component present in a pharmaceutical drug product. Components to be considered include active pharmaceutical ingredient(s), excipients, impurities, as well as extractables and leachables (E&L). E&L do not contribute to the efficacy of the pharmaceutical and therefore offer no benefit. However, E&L may have a negative impact on the safety and/or quality of the drug product and thereby can reduce the benefit/risk ratio.

In consequence, the entry of E&L into the pharmaceutical product needs to be controlled and assessed. Adequate control of E&L requires an understanding of the materials used in production as well as the manufacturing process. In general, first extraction studies will guide concerns, followed by simulation studies, which are designed to mimic reality. In the end, the leachable study has to meet regulatory requirements and must cover real use conditions until the end of product shelf life, and these leachables need to be covered by a thorough toxicological risk assessment.

The webinar presentation will summarize key factors to be considered in a toxicological risk assessment. It will familiarize you with the basic underlying concepts: assessment of toxicological data to obtain a permitted daily exposure (PDE) and, in case of a lack of toxicological information, to make use of the Threshold of Toxicological Concern (TTC). Furthermore, it will be discussed how to deal with compounds of specific concern, such as nitrosamines.

Success factors for the preparation of a high quality E&L toxicological risk assessment are:

1) start early to avoid potential delays of the program and 

2) ensure continuous collaboration of CMC and toxicology functions throughout the entire development process.

Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals

Dr Clemens Günther co present a webinar on Toxicological Risk Assessment on Extractables and Leachables.

Dr. Clemens Günther received his diploma in biology and doctorate in natural sciences from the Free University, Berlin-Germany. He started his professional career in 1990 at Schering AG, Berlin-Germany. From 2000-2006 he became Head of Animal Pharmacokinetics where he also successfully supervised the generation of two doctoral theses. From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects. After the integration of Intendis GmbH into Bayer AG in 2013, he became Director of Nonclinical Safety Consumer Care and later on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals. Meanwhile, Dr. Clemens Günther gained over 30 years of experience in drug development from drug discovery to clinical phase III. His expertise includes nonclinical development and regulatory toxicology of small molecules, biologics, medical devices, and drug device combination products including assessment of impurities, extractables, and leachables. His achievements comprise the successful registration of several pharmaceutical products in various medical indications.

Followed by Dr. J. Susanne Becker, Director of Extractables & Leachables Laboratories at Intertek

 Dr. J. Susanne Becker, Director of Extractables & Leachables Laboratories at Intertek

Dr. J. Susanne Becker completed her Ph.D. at the University of Konstanz in analytical chemistry. After seven years experience in the pharmaceutical industry at Aeropharm and Baxter, she joined Intertek (Schweiz) AG in April 2016 as the Project Leader in E&L and, since 2021, is now the Head of Extractables and Leachables Labs.

Sponsored by Intertek

Helping our clients achieve Total Quality Assurance through custom, flexible, contract services, we provide regulatory-driven, phase-appropriate laboratory services in support of CMC programs for both small molecules and biologics from our GLP / GCP / GMP laboratory network. Services include method development and validation, analysis, stability studies, cGMP quality control testing. Intertek’s Switzerland testing laboratory, located in Reinach, is an advanced analytical testing facility, providing comprehensive pharmaceutical testing, materials analysis and chemical testing to clients in the pharmaceutical, medical device and drug delivery sectors. Our laboratory has specialist expertise in extractables and leachables studies and is equipped with state-of-the-art instrumentation, capable of performing chemical trace analysis, reverse engineering, complex analyses, substance identification and more. The laboratory is compliant with Good Laboratory Practice (GLP) and is on the WHO list of Prequalified Quality Control Laboratories (since 2014). The laboratory has ISO 17025 and ISO 9001 certification and holds Good Manufacturing Practice Compliant (GMP) certification and is FDA inspected.


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