Final Revised Version of BioPhorum Extractable Testing Recommendation Part 1


18th May 2020 | 10:00 am EST | Frances Sexton, Carsten Worsøe, Ken Wong, and Satish Kumar |WATCH FOR FREE

Since the first publication of BioPhorum (previously known as BPOG) Extractable Testing Recommendation in 2014, the combined team of end-users and suppliers has collaborated to examine all improvement opportunities to the original extractable testing recommendation since 2017. During this webinar, the presenters will highlight all the changes to the final revised version of BioPhorum Extractable Testing Recommendation. Specifically, the output of a data review of 26 extractable data sets spanning wide varieties of single use components, which has  led to the changes to be made in the original recommendation, will be presented.

The revised extractable testing recommendation will be presented to highlight:

  1. End-users and suppliers collaboration set up;
  2. Specific updates to the extraction study recommendation;
  3. Specific areas of flexibility when implementing the protocol;
  4. Updates to the analytical test method system suitability.

To facilitate a harmonized extractable data reporting to end users, the presenters will introduce the newly designed BioPhorum Extractable Data Summary (BEDS) template. Some levels of details with regards to what specific information or format of templates are compulsory and what are flexible for supplier to tailor to their own preferences will be detailed during the webinar. How end users can gain access to these extractable summary reports from suppliers, including subsuppliers, will be addressed.

Additionally, several FAQs questions will be presented to clarify some common questions. The webinars will end with 30 minutes of a panel discussion for participants to seek clarify of all presented information.

Presented by

Frances Sexton – TS/MS Bioprocess Chemist – Materials Management, Eli Lilly 

Frances Sexton is a TSMS Bioprocess Chemist working in the Materials Management group of Eli Lilly Kinsale, Ireland. Within her role Frances is the subject matter expert (SME) for the biotech drug substance manufacturing E&L approach. She represents Eli Lilly globally on the BioPhorum E&L workstream.

Carsten Worsøe, Principal Scientist, Extractables and Leachables ,Novo Nordisk

Carsten Worsøe has worked with Extractables & Leachables (E&L) for more than 20 years within the pharmaceutical company Novo Nordisk. Within his role at Novo Nordisk Carsten Worsøe has built internal E&L strategies for container closure systems (drug substance and product), production equipment (single use (SUS) and multiple use (MUC)) and devices. Being a quality expert Carsten Worsøe has worked with colleagues in packaging materials, production, devices, analytical, toxicology, formulation and regulatory to perform risk assessments and documentation for E&L testing in development and life cycle management (LCM) projects. That work has involved different administration forms such as inhalation, parenterals (cartridges, vials and prefilled syringes) and solid oral dosage forms and their subsequent production and delivery devices.

In addition to his work at Novo Nordisk Carsten Worsøe is an acknowledged industry expert within E&L and a frequent chairman (15+), advisory committee member (15+) and presenter at various E&L conferences as well as general pharmaceutical conferences (40+). In addition, Carsten Worsøe has held several meetings with health authority persons in regards to E&L. Finally, Carsten Worsøe is an active member of the international E&L working groups; BioProcess Operation (BPOG) Extractables and Leachables Single Use (SUS) and Extractables and Leachables Safety Information Exchange (ELSIE). Within ELSIE Carsten is a member of the executive committee, as well as the leachables and ICH subteams.

Ken Wong, Deputy Director at Sanofi Pasteur

Ken Wong is a Deputy Director of Process Technology Platform at Sanofi Pasteur. Serving as the Swiftwater site extractables and leachables (E&L) SME but also provide E&L supports to all global sites. His 19-year in biopharma professional career has ranged from R&D to development and commercialization to cGMP manufacturing support. For the last 17 years, he has specialized in E&L in wide range of packaging systems (including lyophilized powders, oral liquids, creams, ophthalmic solutions, transdermal, bio-surgical delivery systems, injectable devices, and inhalation devices for aerosol, solutions and powders). In the last 10 years, he has been heavily involved with Single-Use Technology and actively participating in Disposable workstreams of BioPhorum Operations Group (BPOG), the USP <665> Expert Panel and the ELSIE material working group.

Satish Kumar Mohanvelu – Senior Marketing Manager Emprove® Program, Merck

Satish Kumar Mohanvelu – Senior Marketing Manager Emprove® Program, Millipore Sigma, based at Bedford, Massachusetts, USA.

Responsible for implementing the Emprove® Program with a specific focus on Filtration and Single Use Portfolio of Products. Through this program comprehensive product documentation in the form of dossiers are created to support Biopharmaceutical customers globally.

Satish is a Postgraduate in Biochemistry with about 20 years of experience in the Biopharmaceutical Industry. He has held various positions within the organization with significant time spent in the past managing the Filter Validation Services and laboratories.

 

 


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