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Advanced Level CMC Analytical, Comparability & Stability Testing and Lab Practices for Biotechnology and Biosimilar Products

14 - 15 June 2018

Radisson Blu Edwardian Kenilworth, London

This 2-day course is designed to follow PTI's introductory level course, but may also be taken as a stand-alone class for attendees with experience in aspects of biotechnology. Details will be presented on technical issues in designing and executing specific critical analytical studies. Practical examples will be provided as illustration for key studies and ample time will be allowed for discussion designs and outcomes. Finally, tips on the suitable generation of internal study reports and the presentation of data for regulatory dossiers will be given.

All attendees will be given a USB drive containing over 200 current and draft global regulatory and quality guidance documents associated with the development and commercialisation of biotech and biosimilar products.

Currently, Dr Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.

  • Ascertain the main elements which are critical for establishing reliable and meaningful product specifications for biotech and biosimilar products
  • Hear specific examples of method lifecycle studies including what should go into written procedures for characterisation/comparability methods
  • Examine what kinds of physical and chemical forced degradation studies are applicable to biotech/biosimilar products
  • Overcome the challenges of developing and validating process-specific host cell protein assays
  • Get to grips with critical technical aspects of assessing biotechnology product comparability
  • Explore different types and uses of biotechnology reference standards and materials
  • QC release and stability analysts
  • Stability program managers
  • Product scientists and test method technical experts (R&D and QC)
  • Process analytical chemists and process development scientists
  • Quality assurance specialists
  • GMP compliance auditors
  • Regulatory affairs CMC authors or reviewers
  • Analytical and stability laboratory managers (R&D through GMP)
  • Project managers with CMC responsibilities
  • Business managers with CMC responsibilities
  • Key staff from biotech academic incubators and small start-ups
  • Contract testing labs

 

                                                                 2017 Course Reviews

"Nadine was very good and really went into a lot of detail. I really liked the fact we were given USB sticks with the course content. Excellent course!"

Tamara Mandusic Nazor, Quality Assessor, HALMED

"The trainer was very clear, interesting and an experienced trainer. The topics were very interesting, especially the HCP methods. The literature contained in the USB sticks was also very helpful."

Petra Sokol, Quality Assessor, HALMED

"The course content fitted well with our company's current challenges. I found the course content very relevant and I had also know the trainer from industry white papers."

Analytics Researcher, ILKOGEN

"The trainer was extremely enthusiastic and knowledgeable and managed to explain everything in a simple way. Nadine was also ready to stay over-time to explain and discuss any issues; she was really accommodating."

Bioprocessing Trainer, National Institute for Bioprocessing Research and Training

2016 Testimonials

The course trainer was very knowledgeable and covered topics to a good level of depth.

Scientist,

PsiOxus Therapeutics

It was great that there was real life examples and the trainer conveyed their ability to teach the class well on the topic.

Regulatory Affairs Specialist,

 Polpharma

There was comprehensive instruction about validation of method.


Celltrion

An Overview of CMC Analytical and Stability Studies Required for Biopharmaceutical Products

In around 40 minutes, this webinar covers:

  • Why developing biological/biotech/biosimilar products is so challenging
  • What world-wide regulations detail CMC analytical study requirements
  • The success factors in developing and commercialising biotech/biosimilar products

This webinar was led by Nadine Ritter, trainer for 'CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products' courses.