Aspen Pharmacare’s Gqeberha manufacturing facility already plays an important role in the fight against the novel coronavirus. Dexamethasone, a corticosteroid given to patients with severe Covid-19, is made here, as well as medicine used when patients need ventilation.
Now, the hi-tech sterile production facility will also produce the Johnson & Johnson/Janssen vaccine against Covid-19. The plant was equipped with sterile facilities to enable it to manufacture eyedrops about 20 years ago.
The Gqeberha facility now provides the most significant sterile capabilities on the African continent. Recent investments of more than R3-billion in a second sterile production site were made to allow for the production of anaesthetics, but less complex, production-type vials, ampoules and cartridges, and sterile emulsions, can also be produced.
The facility also has lyophilisation capabilities. Lyophilisation is the process by which medicines in liquid form are freeze-dried to extend their stability and shelf life. The Johnson & Johnson vaccine will not be lyophilised, but other vaccines might be.
Aspen CEO Stephen Saad said: “The new sterile facility contains high technology, state-of-the-art pharmaceutical equipment and systems that will be used to manufacture advanced sterile medicines, including vaccines.”
Aspen is the only manufacturing site on the African continent and in the southern hemisphere selected by Johnson & Johnson to compound, fill, finish and package the Covid-19 vaccine, Saad said.
This means that the ingredients for the vaccine will be combined, the vials will be filled and sealed and the vaccines will be packaged at the Gqeberha facility. In short, Aspen will build and assemble the final product.
“We are very proud and grateful to have the opportunity to partner with one of the world’s largest and most technologically advanced healthcare companies which (has) committed to ensuring equitable access to Covid-19 vaccines.
“This, they have demonstrated through their actions… and was fundamental in our own considerations of whom to partner [with at this time],” Saad said.
He said project teams from Aspen and Johnson & Johnson, responsible for the technical transfer process at the new sterile facility, “worked tirelessly ensuring collaboration in keeping to the ambitious goals and even beating timelines”.
“The majority of the vaccines manufactured at this facility in 2021 will be supplied to South Africa and the member states of the African Union,” Saad said.
“The South African government has an agreement with Johnson & Johnson to deliver 30 million doses of [their] vaccine to South Africans, with the first deliveries being made in April 2021.”
President Cyril Ramaphosa said on Monday (29 March) that of the total 250 million vaccine doses to be manufactured at the facility, 220 million will be made available to the rest of Africa. The other 30 million doses will be for South Africans.
Saad said the plan was to eventually provide up to 400 million doses of the vaccine to the African Union.
“This is a watershed moment for Aspen as we continue to implement our strategic vision of delivering quality, affordable medicines — using high technology pharmaceutical equipment — that contribute to improved health outcomes.
“We are particularly proud that this vaccine manufacture is taking place in Africa. Our sterile capacity is a big step forward to ensuring that Africa has both the capacity and capabilities to reduce its reliance on other countries in addressing the healthcare priorities on the continent,” Saad said.
“We hope that our success will inspire and give confidence to others to further invest in our continent.”
He said the goal was to make one liquid vaccine dose for every African person.
He explained that the agreement with Johnson & Johnson was to compound, fill, finish and package the Janssen (a J&J company) Covid-19 vaccine.
“During this time, the Aspen project team has strengthened its technical competencies, complementing the capabilities of these highly skilled Aspen employees and enhancing a knowledge base in South Africa that will contribute to further solving future public challenges,” Saad said.
“Our sterile capacity is a big step to ensuring that Africa has both the capacity and capabilities to reduce its reliance on other countries in addressing its healthcare priorities.
“The manufacture of the Janssen vaccine builds on the global contributions we have made with both our anaesthetics portfolio and dexamethasone supply. We are particularly proud that this vaccine manufacture is taking place in Africa,” Saad said.
“We have set ourselves a further target to become the pandemic solution for Africa. Security of supply for Africans is best achieved through African facilities.
“Aspen intends to assist with this goal by targeting further enhancement of capacities on the existing sterile footprint to ensure that we have the capabilities to give one liquid dose of vaccine per African person,” Saad said.
While the details of the agreement between Aspen and Johnson & Johnson were confidential, the company said it could produce 300 million doses of the vaccine annually.
Explaining the “general vaccine process”, while stressing this was not specific to any vaccine, the company said that the plant was first put through a dry run to ensure that everything worked. This was followed by a placebo run and then a trial run with the active substance.
“A validation process takes place thereafter, where we would produce at least three batches and submit the data from these batches to the regulatory authorities for review,” an explanation from the company reads,
“Provided that all validation batches are safe, correctly made and are the same as the original product being transferred in, we can then submit the site for registration as a supplier of the product to the healthcare authorities.
“Manufacturing vaccines can take a long time and it is a complex production process. Vaccines are tested at each stage of production and quality control testing is done by various regulatory authorities on the finished product around the world.
“As vaccines are a biological process, manufacturing requires a high level of expertise which we have developed at Aspen over a number of years. Aspen’s vaccine capabilities are in formulation and filling, freeze-drying and packaging,” DM/MC
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