CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Catalent, Recipharm, BD, and LakePharma.
Akston Biosciences, LakePharma in Mfg Pact for COVID-19 Vaccine
Akston Biosciences, a Beverly, Massachusetts-based company that develop and manufactures biologics, including autoimmune disease therapies, insulins, and vaccines, and LakePharma, a San Carlos, California-based biologics contract research, development and manufacturing organization, have entered into a manufacturing pact for Akston’s adjuvated COVID-19 vaccine candidate, AKS-452.
Under the agreement, LakePharma will manufacture commercial quantities of AKS-452, which is scheduled to begin Phase I/II clinical testing later this month (January 2021).
AKS-452 is a COVID-19-specific Fc fusion protein vaccine and is engineered to induce or boost a Th1/Th2 mixed immune response in patients against the receptor binding domain of the SARS-CoV-2, the virus that causes COVID-19, spike protein.
Akston has engineered AKS-452 to use conventional antibody manufacturing techniques, such those with multiple batches over one year; a single 2,000-liter production train would be capable of producing over one billion doses.
Formulation Development/Drug-Product Manufacturing
Recipharm, Moderna in COVID-19 Vaccine Drug Product Mfg, Fill-Finish Pact
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, and Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, have formed an agreement to support formulation and fill–finish of Moderna’s COVID-19 vaccine supply outside of the US.
Subject to regulatory approval of the vaccine in relevant countries outside of the US, it is anticipated that supply will commence in early 2021. The activity will be performed in Recipharm’s drug-product manufacturing facility located in France.
Catalent, Novan in Pact for COVID-19 Program
Catalent and Novan, a Morrisville, North Carolina-based biopharmaceutical company, have entered into an agreement under which Catalent will support chemistry, manufacturing and control (CMC) activities and the development of an intranasal formulation of berdazimer sodium for Novan’s COVID-19 program.
Novan initiated in vitro assessments of its proprietary Nitricil platform against SARS-CoV-2, the virus that causes COVID-19 by targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells. The Nitricil platform stores gaseous species on large polymers, which allow nitric oxide to be applied as timed-release chemical entities. Based on the scientific literature and data available to date (as reported on December 21, 2020) with berdazimer sodium and Novan’s product candidate SB206, Novan believes that nitric oxide may inhibit viral replication by disrupting protein function critical for viral replication and infection through generation of reactive intermediates.
Following the completion of preclinical studies, Novan is targeting filing a potential investigational new drug application with the US Food and Drug Administration and, subject to obtaining additional funding, and initiating human clinical trials in the second half of 2021.
BD Increases Injection Device Orders for COVID-19 Vaccines
Becton, Dickinson and Company (BD), a Franklin Lakes, New Jersey-based medical technology company, has received orders for needles and syringes totaling more than 1 billion injection devices to support global COVID-19 vaccination planning efforts.
The company says this milestone reflects commitments from governments globally, including the US, Australia, Belgium, Canada, Germany, Netherlands, Saudi Arabia, Spain and the UK, among several others, as well as non-governmental organizations supporting vaccine deployment for developing countries.
BD says shipments are underway and more than 300 million injection devices have been delivered globally to date (as reported on December 16, 2020), with the remaining orders to be delivered between now and the end of 2021 to support vaccine administration. These devices are being shipped to governments or appointed distribution partners where they will then be distributed to healthcare facilities based on each country’s individual distribution and allocation strategy. BD continues to be in discussions with governments and non-governmental organizations on the need to place orders immediately for delivery later in calendar year 2021 and 2022.