Leveraging Government support and global partnerships to increase

biologics manufacturing capacity

Leveraging Government support and global partnerships to increase biologics manufacturing capacity

What is BPA’s mission?

• fill key national capability gap in biologics development • deliver key element to Smart State 10 year biotech strategy• devise business model • raise funds to support the model• identify commercial partner• design and build facility to commercial partner’s specs

The capability gap Leveraging Government support and global partnerships

to increase biologics manufacturing capacity

The Business Model

• partner with Contract Manufacturing Organisation (CMO) • public funded capital infrastructure : industry attraction • design and build to CMO’s user requirement• landlord-tenant relationship• CMO has full autonomy in commercial operation• BPA has transitional support function for 2-3 years

Leveraging Government support and global partnerships to increase biologics manufacturing capacity

Q - Why a CMO model? A - a clear market trend over 5+ yrs

• Time-to-market pressure• Offset risk – test the market first• Spare capital during clinical development• Allow developers to focus on areas of strength

• IP generation• Clinical trials• Marketing and distribution

Leveraging Government support and global partnerships to increase biologics manufacturing capacity

BPA’s partnering methodology

• develop value proposition• leverage complementary clinical development providers• invite expressions of interest from CMO’S worldwide• request for proposals from selected group• evaluation of bids against set criteria• offer Terms Sheet to DSM Biologics

Leveraging Government support and global partnerships to increase biologics manufacturing capacity

Strategic investment in biopharmaceutical manufacturing – a Queensland case study

Why DSM Biologics?

• Track record• Financial stability• Commercial focus• No product IP – 100% customer service focus• Technology and commercial differentiators

Quick history

• Dec 2009 - BPA signs Terms Sheet with DSM Biologics• 2010 - concept design underway; negotiation of lease• 2010 - building shell underway• 2011 - completion of facility design and tender package• Jan 2012 - internal fit out underway

Snapshot of the future

• 2012 - complete fit out; procure process equipment• Jan 2013 - commissioning and qualification• Operations commence – July 2013

Leveraging Government support and global partnerships to increase biologics manufacturing capacity

Leverage other service providers:AIBN key linkage