Pharmaceutical Technology Editors

Johnson & Johnson announced on March 8, 2022 that a landmark agreement between Janssen Pharmaceuticals and manufacturer Aspen SA Operations, based in South Africa, will enable the first COVID-19 vaccine to be manufactured by an African company for people living in Africa. The company’s goal is to increase COVID-19 vaccination rates across the continent.

Under the terms of agreement, Aspen will manufacture and provide the Johnson & Johnson COVID-19 vaccine under its own brand name, making the vaccine available to the public sector in Africa, including all 55 Member States of the African Union. The agreement moves forward the goal to ensure equitable, global access to COVID-19 vaccines.

According to a press release, approximately 12% of people in Africa are fully vaccinated, which does not meet the World Health Organization’s target of 70% for all countries. Expanding global vaccination is crucial to reducing the risk of a new SARS-CoV-2 variant emerging.

“With the conclusion of this agreement, our vision for Africa’s own vaccine has become a reality,” said Stephen Saad, Aspen Group chief executive, in a press release. “This has been achieved through tremendous teamwork and collaboration between Johnson & Johnson and Aspen. Through this agreement and their earlier actions, Johnson & Johnson has demonstrated its commitment to our continent. Initially by choosing Aspen, located in Africa, as a core manufacturing partner, and then by showing resolve and dedication to a technical transfer process during the most stringent lockdown periods of the COVID outbreak.”

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Johnson & Johnson have announced a landmark agreement to enable the manufacturing and availability of its COVID-19 vaccine in Africa by an African company.

Johnson & Johnson COVID-19 Vaccine to be Manufactured in Africa

G-CON, a leader in off-site prefabricated, flexible cleanroom solutions, announced on March 8, 2022 that it will be manufacturing and delivering its signature standardPOD cleanrooms in Europe.

standardPODs are off-the-shelf prefabricated cleanrooms that improve drug manufacturing and support development of cell therapies, formulation and filling, and drug substance. standardPODs are available as of March 2022 across the Europe, the Middle East, and Africa (EMEA) market and may be delivered to clients within three months of ordering.

PODs have become a popular design due to their prefabricated and accessible nature, along with their prequalified turnkey benefits. The standardization of PODs allows them to be purchased at a set price and delivered promptly to clients.

"G-CON continues to expand its global product portfolio of pre-engineered standardPODs to help further reduce the time and cost for installing the highest quality cGMP [current good manufacturing practice] cleanroom infrastructure for its clients,” stated Dennis Powers, VP of business development and design consulting for G-CON, in a press release. "Standardization will drive efficiencies as the industry increasingly adopts pre-fabricated modular construction."

G-CON’s signature standardPOD cleanrooms will now be available in Europe.

G-CON’s standardPOD Cleanrooms Available in Europe

Oculis, a global ophthalmology company, announced on March 2, 2022 that it has formed a licensing agreement with Accure Therapeutics, a private translational neuroscience R&D company, granting Oculis exclusive global rights to develop and commercialize ACT-01, a drug candidate for glaucoma and other eye diseases.

ACT-01, which is being renamed OCS-05, is a therapy that protects and prevents damage to the optic nerve and retina. The therapy has the potential to be disease-modifying and aid in the treatment of various eye diseases, such as glaucoma, acute optic neuritis, and geographic atrophy. It works by activating the trophic factor pathways such as IGF-1 and BDNF, which can protect nerve axons.

The license agreement between the two companies will strengthen Oculis’ goal to become a leader in global ophthalmology and develop breakthrough innovations focused on retina, dry eye, and glaucoma.

“We are excited about this agreement as it combines Oculis’s ophthalmology expertise with Accure’s unique neuroprotective approach to help transform the treatment of neurodegenerative diseases in ophthalmology,” stated Riad Sherif, M.D., CEO of Oculis, in a press release. “At Oculis, our focus is on building a highly innovative and differentiated pipeline providing life changing treatments for ocular unmet medical needs, and OCS-05 is a perfect fit for that ambition. Glaucoma is a leading global cause of irreversible blindness, and despite IOP lowering treatments, a significant proportion of patients still go blind. With OCS-05, we have the potential to bring to market the first neuroprotective for glaucoma and other optic neuropathies.”

Oculis has gained exclusive global rights to neuroprotective drug candidate for glaucoma through a licensing agreement with Accure Therapeutics. 

Oculis and Accure Therapeutics Form Licensing Agreement for Glaucoma Drug Candidate

Moderna announced on March 7, 2022 that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to utilize the country as the location of its first messenger RNA (mRNA) manufacturing facility in Africa. The Memorandum of Understanding was achieved with the assistance of the US Government.

The facility will be used for manufacturing drug substances and is expected to expand to include fill/finish and packaging capabilities. Moderna is investing up to $500 million in the new facility, focusing on manufacturing drugs for the continent of Africa. The company’s goal is to produce up to 500 million doses of vaccines per year, with plans to fill doses of its COVID-19 vaccine in Africa as early as 2023.

"Battling the COVID-19 pandemic over the last two years has provided a reminder of the work that must be done to ensure global health equity. Moderna is committed to being a part of the solution and today, we announce another step in this journey—an investment in the Republic of Kenya to build a drug substance mRNA manufacturing facility capable of supplying up to 500 million doses for the African continent each year," said Stéphane Bancel, CEO of Moderna, in a press release. "With our mRNA global public health vaccine program, including our vaccine programs against HIV and Nipah, and with this partnership with the Republic of Kenya, the African Union, and the US Government, we believe that this step will become one of many on a journey to ensure sustainable access to transformative mRNA innovation on the African continent and positively impact public health."

"We are pleased to partner with Moderna in the establishment of this mRNA manufacturing facility to help prepare the country and our sister states on the continent through the African Union to respond to future health crises and stave off the next pandemic," added His Excellency Uhuru Kenyatta, President of the Republic of Kenya. "This partnership is a testament to the capabilities of our community and our commitment to technological innovation. Moderna's investment in Kenya will help advance equitable global vaccine access and is emblematic of the structural developments that will enable Africa to become an engine of sustainable global growth."

Moderna has announced that it has entered a Memorandum of Understanding with the government of the Republic of Kenya to establish its first mRNA manufacturing facility in Africa.

Moderna to Establish its First mRNA Manufacturing Facility in Africa

McGill University announced on Feb. 15, 2022 that university researchers used the Canadian Light Source (CLS) at the University of Saskatchewan to advance a novel method for growing synthetic bone tissue. The breakthrough comes after more than 30 years of the scientific community’s work on developing a synthetic alternative to bone grafts for repairing diseased or damaged bone.

Bone tissue engineering, a rapidly growing field, is focused on growing bone cells in the lab on scaffolds, then transferring these structures into a person’s body to repair bone damage. Like the bone it mimics, the scaffolds need an interconnected network of small and large pores that allow cells and nutrients to spread and help generate new bone tissue.

The McGill research team developed a way to modify the internal structure of a material, known as graphene oxide, to make the material more conducive to regenerating bone tissue. Graphene oxide is an ultrathin, extra-strong compound increasingly used in electronics, optics, chemistry, energy storage, and biology. Because of the material’s unique properties, stem cells tend to transform into bone-generating osteoblasts when placed on the graphene oxide.

The research team is a multidisciplinary group, comprising researchers from McGill’s Departments of Mining and Materials Engineering, Electrical Engineering, and Dentistry. The team found that adding an emulsion of oil and water to the graphene oxide, then freezing it at two different temperatures, yielded two different sizes of pores throughout the material.

When the now-porous scaffolding was “seeded” with stem cells from mouse bone marrow, the cells multiplied and spread inside the network of pores, which is a promising sign that the new approach could eventually be used to regenerate bone tissue in humans.

“We showed that the scaffolds are completely biocompatible, that the cells are happy when you put them in there, and that they’re able to penetrate all through the scaffold and colonize the whole scaffold,” said Marta Cerruti, a materials engineering professor at McGill University, in a company press release.

The researchers used the BioMedical Imaging and Therapy–bend magnet beamline at the CLS to visualize the different sized pores inside the scaffolding as well as the growth and spread of the cells.

“To our knowledge, this is the first time that people have used synchrotron light to see the structure of graphene oxide scaffolds,” said lead researcher Yiwen Chen, who works under Cerruti.

Widespread clinical application of this new approach may still be many years away, but the work could enable other researchers to learn more about how stem cells morph into bone cells, according to Cerruti in the press release.

“Maybe this will lead to a better understanding of the biology of bones that we wouldn't understand otherwise,” Cerruti said in the press release. “Perhaps in the shorter term we can use the methods in the lab to better understand bone and perhaps develop new drugs.”

Researchers at McGill University have made advancements with a novel method for growing synthetic bone tissue.

Researchers Make Progress with New Method of Rebuilding Bone Tissue

Bio-Rad Laboratories launched a range of anti-daratumumab antibodies that are specific for daratumumab (Darzalex) in February 2022. These antibodies inhibit the binding of daratumumab to its target, CD38. Because of their high specificity and high-affinity these recombinant antibodies are suitable for bioanalysis and drug monitoring of daratumumab and its biosimilars.

Bio-Rad’s portfolio of antibodies are generated using the Human Combinatorial Antibody Libraries and CysDisplay, a proprietary method of phage display, along with guided selection methods to obtain highly targeted reagents, according to the company in a Feb. 14, 2022 press release. The anti-daratumumab antibodies are approved for 

 research purposes and for commercial applications providing 

testing services to support preclinical and clinical drug development.

Daratumumab, an anticancer drug that binds to the CD38 protein that is overexpressed in multiple myeloma cells, leads to immune-mediated apoptosis of the tumor cell. The new range of anti-daratumumab antibodies comprises three fully human immunoglobulin G1 inhibitory antibodies that have varying levels of affinity. The antibodies can be used as surrogate positive controls in anti-drug antibody assays as well as for the development of pharmacokinetic bridging enzyme-linked immunoassays to measure free drug.

“We are pleased to continue the expansion of our range of anti-idiotypic antibodies to support researchers developing novel treatments,” said Amanda Turner, Bio-Rad product manager, Life Science Group, in the press release. “Our recombinant production methods result in batch-to-batch consistency, so researchers can rely on our antibodies to deliver reproducible results over the lifecycle of their bioanalytical assays.”

Bio-Rad has launched a range of antibodies specifically for daratumumab that inhibit the binding of the drug to the target antigen, CD38, which allows for highly specific bioanalysis and drug monitoring.