Personalized Medicines: Advances in Genetics and Bioinformatics

Register Free: https://www.biopharminternational.com/bp_w/bioinformatics

Event Overview:

Personalized medicines use advances in genetics and bioinformatics to target specific patient groups and treat previously untreatable diseases. These small patient groups and novel medicinal products result in new challenges for the bioprocessing industry. Find out about the challenges of manufacturing personalized medicines and the lessons learned from the pandemic with a vaccine developer and process equipment manufacturers.

• Key development steps in of formulation-fill-finish processing for lentiviral vectors
• Defining the vector journey on the road to personalized medicine development
• Ensuring sterility with single-use solutions

Key Learning Objectives:

• Design considerations for a bioprocessing system with personalized medicines in mind
• Understanding the role of customer/supplier relationships
• Develop a functional understanding of the FPC60 fill/finish system

Who Should Attend:

• Manufacturing engineers
• Operations managers
• Engineering managers
• Design engineers
• Systems engineers

Speakers

Sade Mokuolu
Global Regulatory and Validation Services Manager
Watson-Marlow Fluid Technology Group

Dr. Sade Mokuolu is global regulatory and validation services manager at Watson-Marlow Fluid Technology Group (WMFTG). She is listed as a co-author on Biophorum’s single-use user requirement (SUUR) guide and has published a number of articles on validation and qualification of single-use systems. Prior to joining WMFTG, she was employed at Pall Biotech as European technical manager for analytical chemistry, providing technical direction on extractables and leachables (E&L) studies of single-use systems. She has presented at international conferences on E&L testing on behalf of the Bio-Process Systems Alliance (BPSA) as well as delivered training to the Australian regulatory agency (TGA), and European GMP inspectors. Additionally, she has extensive pharmaceutical manufacturing experience gained whilst employed by SAFC and Aesica Pharma as a senior process, research, and development chemist. She holds a bachelor of science degree in chemistry from the University of Sussex and a doctorate in organometallic chemistry from the University of Nottingham. Her first ever post was a postdoctoral research fellow at the University of Leeds.

Leslie Southam
QA Manager, Projects
Oxford Biomedica

Leslie Southam (BSc Hons) has seven years of experience working in QA for two ATMP manufacturers and 13 years of experience working in QA within the pharmaceutical industry as a whole. Southam’s current role is QA manager, projects, for Oxford Biomedica—a clinical and commercial stage manufacturer of lentiviral vectors used in both in-vivo and ex-vivo gene/immunotherapy applications including Kymriah (the world’s first commercial cell therapy product) and AZD1222 (Oxford University/AstraZeneca COVID-19 vaccine). In this role, he is the quality lead on the project for the design, construction, and qualification of a new state-of-the-art 7200m2 GMP manufacturing facility and on-site manufacturing start-up activities for AZD1222. This is the second facility design and construction project Southam has been involved in during his time at Oxford Biomedica. Prior to this, Southam worked in various roles within QA at Oxford Biomedica, supporting in-house and contract manufacturing operations. Southam has also been the QA Manager for a start-up cell therapy company who are using innovative technologies to develop the next generation of immunotherapy products. In that role, he was primarily tasked with creating and implementing the company’s quality management system to enable the company to advance its products into early phase clinical trials.

James Drinkwater
Head of Aseptic Processing Technologies & GMP Compliance; Chairman
Franz Ziel GmbH; Pharmaceutical and Healthcare Sciences Society

James Drinkwater is based in the UK with a global support role at Franz Ziel (Germany), a manufacturer of technologies for environmental control in sterile pharmaceuticals and advanced therapy medicinal products (ATMP) manufacturing. Together with the role at Franz Ziel, Drinkwater is the elected head of the not-for-profit Pharmaceutical and Healthcare Sciences Society (PHSS) aseptic processing and ATMP special interest group and co-lead of the EU GMP annex 1 and contamination control strategy (CCS) focus group. His working experience includes 10 years in radio pharmaceutical manufacturing and more than 30 years working in sterile medicinal product manufacturing support—where increasingly aseptic processing applies to ATMPs, particularly gene and cell therapies. Drinkwater is a subject matter expert in barrier technology (isolators and restricted access barrier systems [RABS]) and bio-decontamination with hydrogen peroxide vapor (H202-VHP). Drinkwater is also a member of ISPE and The Pharmaceutical Quality Group (PQG) UK.

Peter Birch
Global Business Development Manager, Biopharmaceutical Equipment
Watson-Marlow Fluid Technology Group

Peter Birch is global business development manager, biopharmaceutical equipment, at Watson-Marlow Fluid Technology Group (WMFTG). Birch has extensive experience in global sales and business development, developing strategic relationships, and collaborating with customers to build effective alliances. Before joining WMFTG, he worked as associate sales director, global key accounts, for Thermofisher Scientific, where his role covered key business areas including medical devices, single-use technology, and cell culture media. Birch has more than 30 years of experience in the biopharmaceutical sector—beginning his career as a research and development scientist at Copenhagen University Hospital before moving on to roles with Hans Buch+Co and Sartorious Stedim Biotech. He holds a bachelor of science/analytical chemistry from the University of Copenhagen.

Register Free: https://www.biopharminternational.com/bp_w/bioinformatics