Biologics CDMO: Four Critical Aspects of Clinical Development, Manufacturing & Analysis

Scorpius BioManufacturing discusses the importance of selecting the right CDMO for your next clinical biologic campaign. During this webinar, they will cover the top four attributes to uncover in due diligence conversations through evaluating analytical integration and new technologies to look for that will mitigate risk and speed up your drug’s manufacturing timelines.

Register Free: https://www.biopharminternational.com/bp_w/four-critical-aspects

Event Overview:

Are you ramping up for clinical development, and deciding which CDMO to outsource your biologic? Learn more about how to efficiently qualify a new biomanufacturing partner organization for their fit with your timelines, budgets, and regulatory needs. This webinar will cover new innovations that help mitigate risk, discuss how analytical support integration can speed timelines, and much more.

• Learn four critical attributes you need to evaluate when outsourcing your clinical candidate with a biologics CDMO.
• Gain insights on due diligence questions when selecting the right CDMO to accelerate your clinical candidate, for timing, capacity, technical expertise, international regulatory compliance, and collaboration.
• Discover how to create an effective RFP for evaluating CDMO fit for your biologic program’s needs

Don’t miss this event and ask your questions as you develop your approach to CDMO partnering selection.

Key Learning Objectives

• Importance of right fit: How to conduct successful due diligence on prospective CDMOs and key ‘asks’ to require from your CDMO partner
• Innovation: How new innovations for biomanufacturing and analytical support can mitigate your biologic’s risks and reduce timing delays
• Power of an integrated CDMO: How time can be harnessed by selecting a CDMO partner that supports biomanufacturing and analytical testing from the same facility

Who Should Attend

Outsourcing (purchasing) management, CMC leads, program management, bioprocess management, analytical heads, process development management, operations management, executive staff, manufacturing science and technology personnel.

Speakers

Mike Fiske
Vice President, Manufacturing Sciences
Scorpius Biomanufacturing

Mike Fiske is Vice-President of Manufacturing Sciences at Scorpius BioManufacturing, responsible for managing the operation of a multi-use, cGMP-compliant, contract manufacturing facility designed for the development and manufacture of advanced therapies. He has more than 30 years in the biotechnology industry as a protein chemist, analytical biochemist, process development scientist, and cGMP operations manager. Mike has an extensive background in cGMP compliance, including biomanufacturing facility design, construction, and validation. He also has considerable experience in biologics process development, analytical test method development, and validation as well as cGMP manufacturing and QC release testing of clinical-grade biologics. Mike holds a Master of Science in Biochemistry from SUNY Binghamton.

As Vice-President, Mike provides leadership for all aspects of ongoing biomanufacturing operations, including technology transfer, process and analytical methods development, and the manufacture and testing of cGMP-compliant, clinical-grade biologics, including recombinant therapeutic proteins, monoclonal antibodies, whole cell and subunit-based vaccines, and cell therapy products. He also assists clients with preparation of CMC regulatory documentation and interactions with regulatory agencies.

Brian O’Mara
Senior Director, Manufacturing Science and Technologies
Scorpius Biomanufacturing

Brian O’Mara is the Senior Director of Manufacturing Science and Technology at Scorpius BioManufacturing responsible for process implementation and all aspects of cGMP biomanufacturing at Scorpion’s multi-use, cGMP-compliant contract biomanufacturing facility. Brian has more than 20 years of industrial biotechnology experience in downstream process development of early and late-stage protein therapeutics from mammalian and microbial expression systems. He also has extensive experience in the development of protein conjugates, including antibody drug conjugates, bi-specifics, and PEGylated molecules. He has experience in scale-up and technology transfer, CDMO management, process characterization, preparation, and oversight of PPQ campaigns and associated CMC regulatory filings.

As Senior Director, Brian manages the cGMP-compliant manufacturing-related activities of biologics products, including technology transfer, process characterization, facility fit, process validation, and manufacture of clinical-grade materials.

Autumn Stroud
Principal Scientist, Protein
Chemistry, Analytical Sciences
Development Group
Scorpius Biomanufacturing

Autumn Stroud is a Senior Scientist in the Protein Chemistry Analytical Development Group at Scorpius BioManufacturing. She is responsible for developing analytical methods in support of process development, process characterization/process validation, in-process testing, QC release testing, and stability testing.

Autumn has more than 15 years in the biotechnology industry as an accomplished analytical biochemist, process development scientist, supervisor, and operations manager. She has extensive experience in the development, validation, and commercialization of human and veterinary clinical diagnostic test kits, the development of cGMP-compliant processes for the manufacture of recombinant protein and monoclonal antibody ancillary materials as well as the management of cGMP manufacturing and QC release testing of components for use in various clinical diagnostic platforms.

As a Senior Scientist at Scorpius Autumn manages all aspects of protein-based analytical methods tech transfer, method development, phase-appropriate validation, and transfer to Quality Control supporting the biomanufacturing of cGMP-compliant biologics, including recombinant therapeutic proteins, monoclonal antibodies, whole cell and subunit-based vaccines, and cell therapy products.

Register Free: https://www.biopharminternational.com/bp_w/four-critical-aspects