CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects
The latest from CDMOs, CMOs, and suppliers in supporting COVID-19 efforts featuring MilliporeSigma, Cytiva, Emergent BioSolutions, Recipharm, Kaneka, Marken, Croda, and Wavelength Pharmaceuticals.
Chemicals/Chemical API Manufacturing
Kaneka To Supply API to Fujifilm for Potential COVID-19 Antiviral
Kaneka, a Tokyo-headquartered chemical manufacturer, has reached an agreement with Fujifilm to supply the drug substance for Fujifilm’s influenza antiviral drug, Avigan (favipiravir), which is being evaluated as a potential treatment for COVID-19.
Kaneka reported on April 16, 2020 that it plans to make capital investments, personnel-allocation changes, and production-plan adjustments to begin supplying the drug substance in July (July 2020).
The Japanese government is increasing its stockpiles of Avigan, and Fujifilm has expanded its production systems and has started increasing its production of Avigan.
Source: Kaneka Corporation
Wavelength Expands Supplies Drug Ingredients for COVID-19 Patients
Wavelength Pharmaceuticals, a Petah Tikvah, Israel-based supplier of active pharmaceutical ingredients (APIs), has expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical-care patients.
Demand for these products, including midazolam, a medication used for anesthesia, cisatracurium, a muscle relaxant, and rocuronium, a muscle relaxant, has increased as a result of increased demand in treating COVID-19 patients.
Source: Wavelength Pharmaceuticals
iBio Forms Pact with IDRI for COVID-19 Vaccine Candidate
iBio, a New York-based plant-based biologics manufacturer, and the Infectious Disease Research Institute (IDRI), a non-profit global health organization, have signed two master services agreements (MSAs) and a memorandum of understanding (MoU) in support of iBio’s SARS-CoV-2 Virus-Like Particle vaccine development.
Under the MSAs, IDRI will support preclinical development and provide clinical trial oversight, and iBio will provide process development and manufacturing services to IDRI. Additionally, the MoU calls for iBio and IDRI to establish a separate, additional agreement within the next 60 days (as reported on April 9, 2020) if the company opts to include one of IDRI’s adjuvants in the COVID-19 vaccine development program (IBIO-200). The MSAs and the MoU integrate IDRI into iBio’s collaboration with the Texas A&M University System to create a partnership that brings technologies and capabilities to the task of moving IBIO-200 into the clinic.
Emergent BioSolutions Gets $14.5-M Contract for COVID-19 Treatment
Emergent BioSolutions, a specialty biopharmaceutical company and contract manufacturer, has entered into a formal partnership with the US government to expedite development of a plasma-derived therapy for patients with COVID-19.
Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March (March 2020).
COVID-HIG is a human hyperimmune product candidate being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. Emergent says COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.
Emergent and the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), have agreed to incorporate the company’s COVID-HIG product candidate into one of NIAID’s clinical studies for assessment of treatments for COVID-19 once clinical material is available, and the study begins. Emergent has already initiated plasma screening and collection of human plasma with antibodies to SARS-CoV-2 that will be further purified and concentrated through manufacturing of COVID-HIG.
Source: Emergent Biosolutions
MilliporeSigma Supports Jenner Institute in COVID 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.
Cytiva to Support Mfg of COVID-19 Vaccine Candidate
Cytiva, formerly known as GE Healthcare Life Sciences, is developing a specific prototype affinity resin for the University of Queensland (UQ) in Brisbane, Australia, who is conducting preclinical testing for a COVID-19 vaccine candidate.
Cytiva will bring manufacturing support and technology to the overall program, including supporting the making of Phase I clinical trial material at the Commonwealth Scientific and Industrial Research Organization, an Australian government scientific research group. Cytiva will also create a specific prototype affinity resin for vaccine purification at its site in Uppsala, Sweden and support scale-up with planning for Phase II material manufacturing through its center in Marlborough, Massachusetts.
In January 2020, UQ was tasked by the Coalition for Epidemic Preparedness Innovations (CEPI) to develop a vaccine for the COVID-19 virus. One month later, the team created its first vaccine candidate in the laboratory. UQ’s candidate is currently in preclinical testing.
Marken Expands Direct-to-Patient Services in Wake of COVID-19
Marken, a provider of logistic and supply-chain services for clinical trial materials and a wholly owned subsidiary of the UPS Healthcare Division, has expanded its Direct to/from Patient (DTP/DFP) and Home Healthcare (HHC) services due to shelter-in-place restrictions and reduced hospital capacity as a result of the COVID-19 pandemic disturbing traditional onsite clinical trials.
Direct to/from Patient (DTP/DFP) and Home Healthcare (HHC) services ship treatments directly to the homes of clinical trial participants.
After sponsors secured permission to include DTP services into their protocols, Marken coordinated logistics and delivery clinical drug products directly to patients participating in trials throughout Asia, Europe, the US and Latin America. All Marken staff and selected partners are trained to provide DTP services after the personnel perform risk assessments to ensure time and temperature control will be maintained for each shipment.
Recipharm Testing Erdosteine as a Potential COVID-19 Treatment
Recipharm, a CDMO of active pharmaceutical ingredients (APIs) and drug products, is testing erdosteine, indicated for the treatment of acute and chronic respiratory diseases, including chronic obstructive pulmonary disease, in a clinical study as an add-on treatment for COVID-19 patients.
Erdosteine is a proprietary API of Recipharm. Erdosteine was discovered and developed in Italy at Recipharm’s facility in Paderno Dugnano.
The clinical study, which began on April7, 2020, is being conducted in clinical centers involved in COVID-19 treatment in Milan and Bergamo, Italy. Both Milan and Bergamo are based in Lombardy, the Italian region most affected by the virus.
The study involves around 100 patients affected by COVID-19 and discharged from hospitals, and is evaluating if erdosteine improves respiratory symptoms (dyspnea, cough, asthenia) and reduces the time to reach a negative test result for SARS-CoV-2. First results from the study are expected in two months (from April 2020).
Croda Supports Sanitizer and Vaccine Development for COVID-19
Croda, a producer of oleochemicals, excipients, and other ingredients, is supporting the development of vaccines and the manufacturing of hand sanitizers during the outbreak of COVID-19.
The company is supplying additional glycerin to their customers in Western Europe. Croda has gifted enough glycerin to manufacture five million bottles of hand sanitizer.
Croda’s saponin vaccine adjuvants are also being gifted to projects working on a vaccination for COVID-19.