• I have just spent a good 30mins listening to a webinar from Eden Biodesign. The topic of discussion was the challenges facing those developing Novel Vaccines and what Eden are doing to help overcome them.

Challenges

• Lots of vaccines are becoming “small molecule like”
• There is no platform technology for novel vaccine production everything is bespoke
• There is limited support available (regulatory and production expertise)

Dynamic Market

• mAb is a large market – in vaccines its now bigger than small mollecules
• Its a growing market
• Deep product pipeline

Novel Vaccines

• New Producs constantley emerging
• Pandemic infection preparation
• Growing markets in developing world
• Bioterrorism preparation
• Offer good economics
• Growth of therapeutic vaccines
• Still lots of interest from Big Pharma

Manufacturing changes

• Traditional techniques are still important
• Mammalian cell lines
• Microbial fermentation
• Chromatographic purification techniques

All associated with analytical challanges

Monoclonals are becoming “small molecule like”

• Mainstream technology
• Platform manufacturing is now becoming a reality
• Greater availability of expertise
• Commercial scale ready systems available
• Easily outsources production
• Regulations have matured, comparability guidelines and FDA, CDER control rather than CBER control

Challenges for novel vaccine process development

• Speed, robustness and transferability
• Cost of goods pressure
• Production expertise is limited
• Hard to characterise
• Challenging to validate and reproduce processes
• No pre-determined acceptance criteria
• No dominant production platform
• Constraints on process change
• Processes can be difficult to scale up and transfer
• Limited expert skills and knowledge available

In order to overcome these issues people are investing in dedicated facilities early on which significantly raises the financial risks associate with a programme.

How are Eden meeting these challenges

• Innovative facility design
• New analytical tools
• More platform like technologies
• knowledge management focused on product quality
• Contained facilities
• Disposable technologies
• Skid mounted unit operations (facilities that can be flexible to requirements)
• Wide range of expertise and experience in house

Important regulatory changes – FDA published a CFR that Live Vaccines can be be produced in multi product facilities.

This webinar series is ongoing so I suggest you have a look (link)

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com