Contract Service Tapped to Produce COVID-19 Vaccines

A key driver of the massive effort to manufacturer and deliver COVID-19 vaccines in record time has been the development and production support provided by contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). This article, which was sourced from news reports and press releases, takes a look at announced contracts and partnerships to produce the lead vaccine candidates in recent months.

Pfizer-BioNTech mRNA-based vaccine

Pfizer will use its extensive manufacturing network to handle much of the manufacturing for its messenger-RNA COVID-19 vaccine, BNT162b2, developed with BioNTech. Raw material manufacturing will be performed at the company’s St. Louis, MO, facility; drug substance manufacturing in Andover, MA, and formulation and fill in Kalamazoo, MI. A Pfizer plant in Belgium will produce vaccines for the European market. In September 2020, BioNTech added a third manufacturing site in Germany with the acquisition of a Novartis GMP production facility in Marberg (1).

Even with expanded inhouse capacity, BioNTech contracted with contract service providers for specialized processes. Rentschler Biopharma will provide large-scale downstream processing of the mRNA vaccine drug substance at its headquarters in Laupheim, Germany (2). Siegfried agreed to dedicate a production line at its Hameln, Germany site for aseptic fill/finish and storage (3).

To accommodate the vaccine production, Pfizer reported in May 2020 that it planned to outsource production of other drugs to free up capacity for the vaccines (4).

Moderna: mRNA-based vaccine

Moderna’s messenger RNA-based COVID-19 vaccine was granted Emergency Use Authorization by FDA in December 2020 (5) and conditional marketing authorization from the European Medicines Agency in early January 2021 (6). The company has contracted with a number of contract manufacturing facilities to fill expected production demands.

In May 2020, Moderna entered into a 10-year strategic collaboration agreement with Lonza to enable larger-scale manufacture of the vaccine (7). The companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland and will manufacture the vaccine at both sites. Technology transfer began in June 2020, and the companies manufactured the first batches of the vaccine at Lonza US in July 2020.

Also in May 2020, CordenPharma was contracted to manufacture large-scale volumes of Moderna’s lipid excipients to be used in the vaccine (8). The companies have expanded their original 2016 agreement to meet the increased demand and will focus on securing a future long-term supply.

Recipharm’s drug product manufacturing facility in France will be used for formulation and fill/finish of Moderna’s vaccine supply outside of the US (9).Laboratorios Farmacéuticos Rovi was selected by Moderna in July 2020 to provide large-scale, commercial fill/finish manufacturing of the vaccine at its facility in Madrid, Spain (10). Rovi will handle vial filling and packaging capacity via a new production line and equipment for compounding, filling, automatic visual inspection, and labeling to produce hundreds of millions of doses of the vaccine outside of the US.

For the US market, Catalent will provide vial filling, packaging capacity, and additional staffing at its Bloomington, IN biologics facility to support the production of 100 million doses of the vaccine (11).

Johnson & Johnson adenovirus-based vaccine

Production of Janssen Pharmaceuticals’, a Johnson & Johnson company, adenovirus-based vaccine, was planned for the company’s facilities as well as supporting contract manufacturers. Emergent BioSolutions has been selected to provide large-scale drug substance manufacturing of J&J’s vaccine via a five-year, $480 million manufacturing services (12). Emergent will offer large-scale manufacturing at its Bayview facility in Baltimore, MD .

Catalent’s Biologics’ Bloomington, IN facility will also provide large-scale commercial manufacturing of the J&J vaccine along with accelerated availability of manufacturing capacity (13).

AstraZeneca: adenovirus-based vaccine

Three contract manufacturers announced contracts for drug substance manufacturing and fill/finish of AstraZeneca’s COVID-19 vaccine, AZD1222, co-developed with the University of Oxford and authorized for emergency supply in the United Kingdom in December 2020 (14); clinical trials are ongoing in the US.

HALIX will handle large-scale commercial manufacturing of the drug substance at its current good manufacturing practice (CGMP) facility at the Leiden Bio Science Park in the Netherlands. The company will also continue its role as one of the original partners in the University of Oxford’s consortium for the manufacturing of the vaccine (15).

Catalent has announced the company will manufacture drug substance for AZD1222 at its commercial gene-therapy manufacturing facility in Harmans, MD (16) and will provide large-scale vial filling and packaging of the vaccine at its facility in Anagni, Italy (17).

Novavax: protein-based vaccine

Phase III trials for Novavax’s NVX-CoV2373 protein-based vaccine are underway in the UK and US with contract manufacturers engaged in production and filling. Novavax contracted Fujifilm Diosynth Biotechnologies (FDB) to manufacture bulk drug substance for the vaccine, and in July 2020, FDB’s site in Morrisville, NC began production of the first batch of NVX-CoV2373 under Novavax’ $1.6 billion award by the US government as part of Operation Warp Speed. In January 2021, FDB reported that the company completed exapnasion at its College Station, TX facility to accommodate large-scale bulk drug substance production (18).

References

1. BioNTech, “BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021,” Press Release, Sept. 17, 2020.
2. Rentschler, “Joining Forces Against SARS-CoV-2,” Press Release, Oct. 8, 2020.
3. Siegfried, “Siegfried and BioNTech Sign Contract for the Aspectic Fill & Finish of a COVID-19 Vaccine,” Press Release, Sept. 14, 2020.
4. C. O’Donnell and M. Erman, “Pfizer to Outsource Some Drug Production, Focus on Coronavirus Vaccine,” www.reuters.com, May 8, 2020.
5. FDA, “FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine,” Press Release, Dec. 18, 2020.
6. EMA, “EMA Recommends COVID-19 Vaccine Moderna for Authorization in the EU,” Press Release, Jan. 6, 2021.
7. Lonza, “Moderna and Lonza Announce Worldwide Strategic Collaboration to Manufacture Moderna’s Vaccine (mRNA-1273) Against Novel Coronavirus,” Press Release, May 1, 2020.
8. CordenPharma, “Moderna Extends Lipid Supply for Coronavirus Vaccine, Press Release, May 28, 2020.
9. Recipharm, “Recipharm and Moderna Finalize Agreement for Aseptic Drug Product Manufacturing and Fill-Finish for Supply to Countries Outside the US,” Press Release, Dec. 30, 2020.
10. Moderna, “Moderna and ROVI Announce Collaboration for OUS Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate,” Press Release, July 9, 2020.
11. Catalent, “Moderna and Catalent Announce Collaboration for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate,” Press Release, June 25, 2020.
12. Emergent, “Emergent Biosolutions Signs Five-Year Agreement for Large-Scale Drug Substance Manufacturing For Johnson & Johnson’s Lead COVID-19 Vaccine Candidate,” Press Release, July 6, 2020.
13. Catalent, “Catalent Signs Agreement with Johnson & Johnson to be US Manufacturing Partner for Lead COVID-19 Vaccine Candidate,” Press Release, April 29, 2020.
14. AstraZeneca, “AstraZeneca’s COVID-19 Vaccine Authorized for Emergency Supply in the UK,” Press Release, Dec. 30, 2020.
15. HALIX, “HALIX Signs Agreement with AstraZeneca For Commercial Manufacture Of COVID-19 Vaccine,” Press Release, Dec. 8, 2020.
16. Catalent, “Catalent Signs Agreement with AstraZeneca to Expand Manufacturing Support for COVID-19 Vaccine AZD1222,” Press Release, Aug. 24, 2020.
17. Catalent, “Catalent Signs Agreement with AstraZeneca to Manufacture COVID-19 Vaccine Candidate,” Press Release, June 15, 2020.
18. Fujifilm Diosnyth Biotechnologies, “Fujifilm Diosynth Biotechnologies Begins Production of Two COVID-19 Vaccines Candidates at Texas Facility,” Press Release, Jan, 11, 2021.

Article Details

Pharmaceutical Technology
Supplement: Partnering for Bio/Pharma Success
February 2021
Pages: s29–s30

Citation

When referring to this article, please cite it as The Editors of Pharmaceutical Technology, “Contract Service Tapped to Produce COVID-19 Vaccines,” Partnering for Bio/Pharma Success Supplement (February 2021).