OBN BioTuesday: 'What's New in Protein Expression - Taking New Therapeutic Drugs to the Clinic', kindly sponsored by Lonza
Over the past few years the number of recombinant proteins used for therapeutic applications has increased exponentially. The technology involves complex glycoproteins and antibodies with relatively high production needs. These requirements have driven the development of a variety of improvements in protein expression technology, particularly involving mammalian and microbial culture systems. Therapeutic protein drugs are an important class of drugs particularly in areas of unmet need. Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, infectious disease, autoimmunity/inflammation, and genetic disorders. The latest advances in protein-engineering technologies have allowed drug developers and manufacturers to refine and exploit desirable functional characteristics of proteins of interest while maintaining or enhancing product safety or efficacy or both.
Manufacturing recombinant therapeutic proteins at an industrial-scale is more than having large steel tanks, large plastic bags, or even high productivities. To be successful you need : 1. To produce a therapeutic drug with the required cGMP quality attributes: potency or strength, identity, safety profile, quality, and purity – collectively, these attributes are described by the acronym SISQP. 2. Production of the required mass of product to service the patient populations and simultaneously satisfy the needs of SISQP testing. 3. Time from discovery to clinic or to market needs to be considered. 4. Cost-of-goods becomes important for a new therapeutic drug as payers increasingly require both competitive pricing & proven value. Initially, speed trumps this fourth point (cost-of-goods), but the risks of fast but less information need to be balanced with the impact of more certainty and longer timelines
Choice of the right expression and production platform upfront reduces the likelihood and impact of risks associated with these four points, alongside early identification of negative characteristics of the protein molecule, and increases the probability of a successful transition from Phase 1 to approval.
Programme & Speakers
17:30 Registration & Networking
18:00 Welcome by John Harris, CEO, OBN
18:05 Keynote from Andy Racher, Director, R&D IP Strategy at Lonza
18:25 Keynote from Hari Kumar Experienced Pharma Executive | Independent Board Member | ex- CEO of Adheron Therapeutics - 'What to consider when moving therapeutic proteins from development to first in human trials'
18.50 Company Insight from Tom Mander, COO, Domainex, who will address 'Combinatorial Domain Hunting: A proven, high throughput approach to overcome challenges in protein expression to enable structure-based drug design'
19.05 Company Insight from Richard Hart, Director of Business Development, Leaf Expression Systems
19.20 Company Insight TBA
19.35 Audience Q&A with all speakers
20:00 Drinks & Networking
21:00 Event Close
OBN Members: One Complimentary
OBN Member Additional Ticket: £25.00 plus VAT
PHD Students & Research Scientists: Complimentary
Non Members, Non R&D Companies: £50.00 plus VAT
Kindly Supported by: