Pitch for biomanufacturing strategy and bioprocessing facility enters critical phase

Public-private partnership

A proposal to help reverse the yawning trade imbalance in pharmaceutical products is entering a critical phase, as efforts ramp up to secure the public and private investment required for full implementation. The Canadian Bioprocessing Initiative (CBI) needs approximately $300 million over five years to establish a national biopharmaceutical manufacturing institute, a pilot cGMP-compliant biomanufacturing facility and five distributed networks.

Tentatively called the Centre for Biopharmaceutical Manufacturing, the institute and associated manufacturing facility would be located in Ottawa. The suggested locale — a former portion of the Central Experimental Farm now owned by the National Capital Commission — seems to be the proposal’s only major point of contention.

But aside from those who argue for Montreal or Toronto, the initiative has garnered strong support from the relevant industry players as well as within academia and government. CBI would provide a major shot in the arm to Ottawa’s fledgling life sciences cluster and help to tie together the various institutional strengths already located in the region.

The institute would be independent but would likely forge alliances with organizations such as the National Research Council (NRC) and Agriculture and Agri-Food Canada.

The CBI strategy is slated for release this fall and until then its backers are reluctant to discuss specific financing requirements. Instead, they emphasize the urgent need to tackle the transformative changes taking place in the manufacturing landscape for pharmaceuticals, particularly the shift towards biologics and away from chemical synthesis. They argue that massive public and private funding of biotechnology R&D in recent years places Canada in a strong position to establish global presence in biomanufacturing but only if strategic investment decisions are made quickly.

“We’re leaving the value of products off the table because we’re not manufacturing them. If products are manufactured elsewhere they never come back (to Canada),” says Ken Lawless, president & CEO of the Ottawa Life Sciences Council and a key driver behind the initiative. “We want to fill the gap in the pipeline. That includes opening the tap to allow more customers for the CMO (contract manufacturing organization) industry and creating larger opportunities for Canadian-based brand name companies to pick up more global product mandates.”

As CBI’s executive director since 2002, Rick Norland is directing his immediate attention towards finalizing the public-private partnership that’s central to driving the strategy forward and completing the five national networks (see chart).

Each of the national networks has an advisory committee of approximately 15 experts drawn in equal measure from industry, government and academia. The committees have facilitated timely feedback on various aspects of the initiative, which has evolved over time to meet the requirement of the various stakeholders.

“This has to be globally relevant. It’s about Canada’s position in the world,” says Norland. “It’s not just about developing capacity. A key issue is highly qualified personnel (HQP). There are regulatory requirements and we need HQP expertise for this.”

Over its three-year gestation, CBI has identified a gap in Canadian capacity between Phase I and Phase II clinical trials for biopharmaceutical products. That’s the stage where firms are compelled to use foreign facilities to advance product development, allowing value-added to slip across the border.

A not-for-profit bioprocessing facility — complemented by regulatory expertise, a training component and international linkages to other clusters of biopharmaceutical manufacturing activity — is considered the best approach to ensuring that Canadian firms have a level playing field.

“We need to get small- and medium-sized businesses to clinical trials in a timely fashion and shorten the time to market and to revenue,” says Lawless. “This is a key link in the commercialization agenda and making investments is critical if we want to be a global player.”

FIVE CORE ELEMENTS

The CBI strategy has five core elements and Lawless asserts that all must be implemented to enhance its chances for success. In addition to targetting the gap between Phase I and Phase II clinical trials, the strategy also calls for the training of HQP, a doubling of bioprocessing R&D to more than $60 million annually, regulatory foresight and international collaboration and leadership.

The facility itself will focus primarily on the production of therapeutic proteins and will have multiple platforms for mammalian cell, microbial fermentation, viral and transgenic plants and animals. The estimated time for completion could stretch to seven years from concept and design development to commissioning and process validation. It could also be linked with other bioprocessing facilities in Canada, including those at the Alberta Research Council, NRC’s Biotechnology Research Institute in Montreal and NRC’s Ottawa-based Institute for Biological Sciences in Ottawa and the Institute for Chemical Process and Environmental Technology (also in Ottawa).

One biotech insider says the CBI has emerged as an extremely solid initiative that reflects a comprehensive planning and consultation process.

“They’re taking an aggressive approach and they’re confident moving forward to provide a national centre for bioprocessing. There’s a high demand by industry,” he says. “But it’s legitimate for government to say ‘What’s the exit strategy if this thing goes belly up?’ Will they be back for more money in two years if the business case doesn’t work?”

For Lawless and Norland, the question of risk doesn’t detract from the need for CBI. They contend that Canada has no choice but to participate in the massive re-tooling for bioprocessing now taking place in the pharmaceutical sector. A national strategy and pilot facility are also essential, they say, to give Canada’s smaller biopharmaceutical firms assistance in bridging the divide between promising products and the marketplace.

“Canada is number two in terms of the number of biotech firms and there are approximately 115 products in the clinical trials process,” says Norland..

The CBI strategy also has a strong international component. Plans are underway to join forces with bioprocessing players in Sweden, the UK and Raleigh NC, with each contributing their own unique capabilities. It’s also hoped that CBI will help to attract expatriate Canadians to return to Canada to add their expertise to the initiative.

“We hope to repatriate those who already have experience and deploy these people to ensure a strong complement of HQP to build the industry,” says Lawless.

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