CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs and suppliers in COVID-19 efforts featuring Seqens, Catalent, MilliporeSigma, Recipharm, Fujifilm Diosynth, AMRI, and Ajinomoto Bio-Pharma.
Chemicals/Chemical API Manufacturing
Seqens Supports Potential COVID-19 Treatment
Seqens, a CDMO of pharmaceutical synthesis services and a provider of specialty ingredients, is supporting the development and manufacturiing of hydroxychloroquine, a potential COVID-19 treatment and now approved for treating malaria and certain autoimmune diseases.
Three of the company’s European sites (Aramon and Limay in France, Lahr in Germany) have been mobilized to enable the production of more than 150,000 kg annually of hydroxy novaldiamine (HND), an important component of producing hydroxychloroquine. Development occurred at the Seqens Lab, the company’s innovation center, to set up a complete industrial infrastructure to enable the start of the first industrial production for the end of the second quarter of 2020. The company also addressed the scarcity of precursors to HND due to the availability of material, the closing of borders in the main producing countries (India, China) and price inflation. In early April (April 2020), Seqens made the decision to internalize these precursors and in particular, chloropentanone and AB-lactone. The Seqens Lab successfully optimized its existing process of chloropentanone at its site in Germany and adapted it to the production capabilities at the company’s production site in Bourgoin-Jallieu, France. At the same time, the development team at its English site in Middlesbrough studied the internalization of AB-lactone.
In addition, Seqens participates on the INOVA COVID-19 platform, a platform for coordinating the efforts and achievements of global players fighting against the coronavirus.
Recipharm Secures Supply of Chloroquine for COVID-19
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has secured supply of the active pharmaceutical ingredient (API), chloroquine phosphate, a drug already approved for treating malaria, lupus and rheumatoid arthritis and a potential COVID-19 treatment for its drug, Klorokinfosfat RPH Pharma, which is marketed in Sweden by Astimex Pharma, and commenced manufacture of the product.
In addition to manufacturing Klorokinfosfat RPH Pharma, Recipharm has also initiated the development of a new product with hydroxychloroquine as the API. This will allow the company to potentially offer a product containing the other form of chloroquine in case of possible future demand.
While chloroquine products are not currently indicated for treatment or prevention of COVID-19, a number of clinical studies involving chloroquine and hydroxychloroquine have recently been initiated.
AMRI Increases Production of Hydroxychloroquine for COVID-19
AMRI is increasing production of the active pharmaceutical ingredient, hydroxychloroquine sulfate, at its manufacturing facility in Rensselaer, New York to meet demand resulting from potential effectiveness of the product in treating COVID-19 symptoms.
AMRI’s active Type II drug master file for hydroxychloroquine sulfate is available. The US Food and Drug Administration authorized emergency use of hydroxycholorquine sulfate to treat some hospitalized patients with COVID-19.
Catalent, Arcturus Enter Pact to Mfg mRNA-Based COVID-19 Vaccine
Catalent and Arcturus Therapeutics, a clinical-stage messenger RNA (mRNA) medicines and vaccines company, have entered a pact to support the expected manufacture of Arcturus’ COVID-19 mRNA vaccine candidate (LUNAR-COV19), intended to protect against SARS-CoV-2, the virus that causes COVID-19.
LUNAR-COV19 uses Arcturus’ self-transcribing and replicating mRNA (STARR) technology and the company’s LUNAR lipid-mediated delivery to produce a low-dose, potential single-shot COVID-19 vaccine.
The partnership will combine Arcturus’ STARR mRNA vaccine technology with Catalent’s cGMP manufacturing capabilities to produce millions of doses of LUNAR-COV19 mRNA in 2020 and potentially hundreds of millions of doses annually for worldwide use The manufacture of LUNAR-COV19 at Catalent’s drug-substance biomanufacturing facility in Madison, Wisconsin will support human clinical studies and, if successful, commercialization of the vaccine. Preparations for this program have already begun at the Madison facility. Technology transfer will be completed this month (May 2020) and manufacture of the first cGMP batches of LUNAR-COV19 mRNA are expected to be completed by June 2020.
Source: Catalent and Arcturus Therapeutics
Fujifilm to Reserve Mfg Capacity for COVID-19 Therapies
Fujifilm Diosynth Biotechnologies, a biologics CDMO and part of Fujifilm Corporation, announced it will reserve manufacturing capacity for a future COVID-19 therapy for the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the global pandemic.
The Therapeutics Accelerator is working to accelerate drug development and identify a COVID-19 therapeutic candidate based on efficacy and safety data demonstrated in clinical trials as currently there are no established therapies for the treatment of COVID-19.
This agreement will allocate manufacturing capacity in Fujifilm Diosynth Biotechnologies’ large- scale biologics production facility in Hillerød, Denmark. The company will work with a selected pharmaceutical partner in supporting the manufacture and supply for patients with COVID-19 in lower-income countries. Under the agreement, production volumes are secured for 2021 with options for a number of years thereafter.
Fujifilm Diosynth Biotechnologies’ Hillerød cGMP facility is equipped with 6 x 20,000-L bioreactors for the manufacture of cell-culture-derived biologics for clinical and commercial use. The agreement also anticipates that Fujifilm Diosynth Biotechnologies will support drug product and assembly, label, and packaging requirements.
Source: Fujifilm Diosynth Biotechnologies
MilliporeSigma Supports Jenner Institute in COVID-19 Vaccine Mfg
MilliporeSigma and The Jenner Institute, a medical research institute at the University of Oxford in the UK, have initiated production of the institute’s COVID-19 vaccine candidate, ChAdOx1 nCoV-19. Patients are enrolled for clinical trials of this vaccine candidate.
MilliporeSigma previously provided plans to manufacture Jenner’s COVID-19 vaccine candidate. Developing the manufacturing process would normally take at least six months to a year, but that was reduced to two months. Over the last two years, MilliporeSigma’s collaboration with The Jenner Institute has led to the development of a scalable manufacturing platform using disposable technologies for the institute’s adenovirus platform. While the initial work was developed with a rabies vaccine candidate, the platform was then validated with different adenovirus constructs with the aim of accelerating future vaccine development and manufacturing. The organizations first announced their partnership to develop more scalable vaccine manufacturing processes in April 2018.
Formulation Development-Drug Product Manufacturing
Ajinomoto Bio-Pharma Services Forms Mfg Pact for COVID-19 Drug
Ajinomoto Bio-Pharma Services, a CDMO of small- and large-molecules and drug products, has entered into a manufacturing services agreement with CytoDyn, a Vancouver, Washington-based biopharmaceutical company, for the supply of CytoDyn’s investigational new drug, leronlimab, which is currently being used in clinical trial protocols for treating mild-to-moderately ill and severely ill COVID-19 patients.
Ajinomoto Bio-Pharma Services provides drug-product aseptic fill–finish services for CytoDyn. Leronlimab, a l CCR5 antagonist with the potential for multiple therapeutic indications, is being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND) application granted by the US Food and Drug Administration as part of Phase I, Phase II and Phase IIb/III clinical trials. CytoDyn is currently enrolling patients in two placebo-controlled randomized clinical trials for Phase II and Phase IIb/III.
Source: Ajinomoto Bio-Pharma Services
Quotient Sciences Partners for Potential Treatment for COVID-19
Quotient Sciences, a Nottingham, UK-based CDMO, and CytoAgents, a Pittsburgh, Pennsylvania-based biopharmaceutical company focused on viral infectious diseases, have entered into a collaboration to support the development of CytoAgents’ COVID-19 drug candidate, GP1681, a small-molecule inhibitor of cytokine release in activated human immune cells, for Phase I and II clinical trials in 2020.
Under the agreement, CytoAgents will access Quotient’s formulation and manufacturing services to develop and supply drug product for Phase I and II testing in 2020. In parallel, Quotient will work to develop a scalable solid oral dosage form for larger patient trials and commercialization. The program will be conducted at Quotient’s facility in Garnet Valley, Pennsylvania, which has specialized drug handling and containment suitable for highly potent drug candidates.
Scientific consensus is building that severe illness caused by COVID-19 and other infectious diseases is triggered by a phenomenon known as “cytokine storm,” an excessive immune response that attacks the body. GP1681 has been shown to modulate the natural immune response by tamping down various cytokines, according to information from the companies.
Source: Quotient Sciences and CytoAgents