In early 2020, Oxford Biomedica, a Novo Holdings portfolio company, joined a consortium to develop, scale up and manufacture a vaccine candidate for the coronavirus. Extra space at its bioprocessing facility was turned into new production lines in record time, enabling the company to produce tens of millions of doses of the Oxford-AstraZeneca vaccine. The vaccine has been approved by health authorities around the world.

Photo: Specialists at Oxford Biomedica oversee 50L and 200L production units. To accommodate the large volumes required by AstaraZeneca, processing of the vaccine against COVID-19 was scaled up to 1,000L during 2020.

COVID-19 has wreaked havoc across the globe. Social distancing and lockdowns were the first line of defence. Hopes for a long-term solution, however, hinged on developing a safe and effective vaccine ever since WHO declared COVID-19 a Public Health Emergency of International Concern.

One of the leading vaccine candidates was developed in the UK by scientists at the Jenner Institute of the University of Oxford. A consortium led by the Jenner Institute was formed to rapidly develop, scale up and manufacture the vaccine candidate, which Oxford Biomedica, a gene and cell therapy company, joined. The company was an obvious candidate, given its globally leading viral vector manufacturing capabilities as well as vicinity and close ties to the University of Oxford, from which it was spun out in 1995.

Shortly afterwards AstraZeneca, a pharmaceutical and biopharmaceutical company, took a licence to the vaccine from the University and subsequently signed the first of two supply agreements with Oxford Biomedica.

Providing access to the vaccine
Making medication of critical importance is not new to Oxford Biomedica. As an example, the company makes lentiviral vectors for Kymriah, a medication for the treatment of childhood leukaemia. Thus, when joining the Consortium, Oxford Biomedica reassured its multiple partners, including pharma giants such as Novartis, BMS and Sanofi that this would not harm their relationships. In fact, the company reassured the market that it would not detract from signing new agreements in the lentiviral space. Proof of this came in July when it signed a 3-year supply agreement with Axovant expanding an existing agreement. In August, the company signed up a new partner, Beam Therapeutics, to collaborate on next generation CAR-T therapies.

As an established clinical and commercial manufacturer of lentiviral vectors, Oxford Biomedica was in a strong position to support. The vaccine candidate, however, is adenovirus-based, thus requiring a slightly different method of production and a substantial upscale of production facilities.

The fact that Oxford Biomedica had recently completed the construction of Oxbox, its brand-new bioprocessing facility, proved to be a fortunate coincidence. The original plan had been to bring the capacity online step by step to support the partner programmes, most of which are early stage, that Oxford Biomedica is developing. Working with the AstraZeneca meant that the company will work with the vaccine for at least 18 months before several of its partners will require production capacity.

In a unique position to help
In other words, Oxford Biomedica was in a unique position to help. Roughly 100 employees were brought on, an agreement with the United Kingdom’s dedicated Vaccines Manufacturing Innovation Centre (VMIC) was struck to bring in new production equipment, processing was scaled up from 200L to 1,000L to accommodate the large volumes required by AstraZeneca, and regulatory approval was secured. Oxford Biomedica had expected to bring one production unit – technically known as a GMP (good manufacturing practice) suite – online during 2020. By October, four units were up and running.

“We are delighted that we now have all four GMP suites in Oxbox operational, more than doubling our manufacturing capacity from 2019. I want to personally thank all of those at Oxford Biomedica who have worked tirelessly to bring these suites online so quickly to enable the manufacturing scale of the vaccine candidate,” said John Dawson, CEO, Oxford Biomedica, when the regulatory approval was given.

At this point, Oxford Biomedica had one GMP suite dedicated to its cell and gene therapy work, while the three others are dedicated to the vaccine. These are running around the clock to produce batches of the vaccine against COVID-19, corresponding to doses in the tens of millions. In accordance with the agreement, Oxford Biomedica manufactures the vaccine in bulk. AstraZeneca oversees the separate fill and finish partnerships and, ultimately, manages the global distribution.

Through partnerships with manufacturers in several countries, such as the one with Oxford Biomedica, AstraZeneca announced in November that it was making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.

The Oxford-AstraZeneca vaccine was approved for use in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) on 30 December 2020. It was subsequently approved for use in Europe by the European Medicines Agency (EMA) on 29 January 2021. Health authorities in countries around the world, including Mexico, India, and Argentina, have also approved the vaccine.

Key dates for Oxford Biomedica’s COVID-19 activities

1. April 20: Oxford Biomedica joins a consortium led by the Jenner Institute, University of Oxford to rapidly develop, scale and manufacture a potential vaccine for COVID-19.

2. May 20: Oxford Biomedica signs initial 1-year clinical and commercial supply agreement with AstraZeneca at 200L scale.

3. June 20: Oxford Biomedica signs 5-year agreement with VMIC (Vaccines Manufacturing Innovation Centre) to enable the rapid manufacture of viral vector-based vaccines, providing equipment for two GMP suites in Oxbox to further scale up AstraZeneca or other viral vector vaccine candidates.

4. September 20: Oxford Biomedica signs 18-month supply agreement under a 3-year master services agreement with AstraZeneca, paying GBP 15 million capacity reservation fee and potential additional revenues in excess of GBP 35 million, scaling up to 1,000L production.

5. October 6: Oxford Biomedica receives MHRA (UK’s Medicines and Healthcare Products Regulatory Agency) approval for third vaccine manufacturing suite at its Oxbox production facility, with four suites in total now approved at the site.

Oxford Biomedica in brief | Novo Holdings’ investment
Oxford Biomedica is at the centre of the rapidly emerging gene and cell therapy sector by which life-changing and curative treatment has become a therapeutic reality. Leveraging its world-leading LentiVector® platform, the group benefits from a dual strategy, supporting its partners in the development and commercialization of their gene and cell therapy programmes while also pursuing the development of a proprietary product portfolio for later out-licensing.

In 2019, Novo Holdings invested GBP 53.5 million in Oxford Biomedica, corresponding to 10.1% of the share capital. In 2020, Novo Holdings participated in a follow-on investment of approx. GBP 4 million, bringing its total investment in Oxford Biomedica to GBP 57.5 million.