In a move to launch the US pharma giant Johnson & Johnson’s Covid-19 vaccine in India, pharma company Biological E has begun discussions with the country’s apex vaccine testing laboratory, the Central Drugs Laboratory.
Last week, the officials of Hyderabad-based Biological E — the company contracted by J&J to mass manufacture its one-shot vaccine — met officials at CDL in Himachal Pradesh’s Kasauli to explain the standard testing procedures for the American vaccine.
“The officials from Biological E, last week, began their discussions with CDL. While they have explained to the laboratory officials the methods they use for quality testing, the CDL officers, in turn, have asked the company to supply the specific list of reagents used for testing,” said a senior government official privy to the development.
“CDL generally asks for demonstrations from the manufacturers to conduct the quality tests. Company officials wanted to understand the expectations from CDL so they could start preparations,” the official added.
Biological E told the Reuters in February that it was looking to contract-manufacture about 600 million doses of the J&J vaccine annually.
In April, J&J told ThePrint that it is in discussions with the Government of India with the objective of starting a bridging clinical study. However, now, according to new rules, it is not mandatory for the vaccine approved by the US drug regulator to conduct bridging trials in India.
ThePrint sent an email seeking a response from Biological E and J&J, but did not receive one till the time of publishing this report.
CDL told Biological E it can perform tests
In the meeting, according to the official quoted above, representatives from Biological E wanted to know what type of tests will be conducted on their vaccines and using which techniques.
“For instance: In J&J’s vaccine, the potency testing procedure is quite different from the other Covid-19 vaccines that are currently being tested,” the officer said.
“CDL can probably modify the procedure used for testing rotavirus vaccines as both the platforms are quite similar. J&J’s testing may require lysate sensitivity testing too, which has altogether a different technique,” he added.
“The apex laboratory has communicated to the company that it can perform these tests but they may need to supply some reagents.”
CDL generally develops its own technique of testing the vaccines by combining the procedures adopted by the manufacturer and innovating their procedures over time to save cost, time and ensure accurate results.
“The lab will use the company’s procedure, their own procedure, compare results using both methods and find one final method that saves time, ensures quality and is cost effective,” the officer explained.
This article was first published on ThePrint.in