New Delhi: Department of Science and Technology (DST)-funded startup Seagull Bio Solutions, has developed kits for testing symptomatic COVID-19 infections and geared up its efforts for production of vaccine.Seagull Bio Solutions, a startup working on new biological technologies, has undertaken the development of Active Virosome Vaccine and Immuno diagnostic kits for COVID-19 emergency.
Active Virosome Technology (AVT) developed by Seagull Bio is useful for the production of vaccines for the prevention of COVID-19 infection and also immunodiagnostic ELISA kits for COVID-19.
‘Accurate diagnostics, breaking the chain of transmission, therapy and preventive measures including safe and effective vaccines are the foundational pillars of addressing the challenges of COVID-19. Of these, developing vaccines has the longest timeline and so it is essential to fast track that activity now,’ said DST Secretary Prof Ashutosh Sharma said.
Polymerase Chain Reaction (PCR)-based diagnostic kits, which are currently available in India, are rapid and enable detection of active COVID 19 infection but it cannot identify asymptomatic infections or those people who were exposed to or infected with COVID-19 in the past but did not suffer from the disease or have recovered from COVID-19 disease and may still be spreading the virus. In contrast, Immunodiagnostic kits help in detection of antibodies to COVID – which can identify these infections also, the DST said.
‘Therefore, SBPL has initiated efforts to produce Immunodiagnostic kits for COVID-19. These tests will enable healthcare researchers to monitor the spread of COVID-19 more accurately.
Seagull Bio based out of Entrepreneurship Development Center (Venture Center)at Pune and supported under Seed Support System of the Technology Development Board (TDB) of DST, is producing two types of Active Virosome (AV) agents-one expressing S protein of COVID-19 (AV-S) and another one expressing structural proteins of COVID-19 (AV-SPs).
SBPL is currently amplifying the synthesis of both these agents upto 10 mg levels so that their immunogenicity can be tested.
‘This test will first be performed in wild type mice to ascertain the ability of AV-S & AV-SPs to induce anti-COVID19 neutralising antibodies & cellular immune response,’ the DST said.
Once this is proven, they will undertake efficacy studies in ACE-2R+ mice, which are used as a model for SARS disease. In parallel, a bioprocess for production of AV- agent will be established & the AV-agent produced in large scale about 100,000 vaccine doses, the DST added further.
Detailed toxicity, safety & pharmacokinetic study will be performed in ACE2R+ mice and another small animal species or Monkeys, and then the AV-vaccine agent will be prepared for Phase I clinical trials.
The company anticipates that the unique features of AVs will enable starting Phase I trials by the end of 18-20 months. In parallel to this Vaccine project, SBPL will also use the Active Virosomes expressing S protein of COVID-19 as an antigen for developing immunodiagnostic kits.
SBPL expects the Immunodiagnostic kits to be ready for field trials by the end of August this year and approved by the end of 10-11 months. On the other hand, the AV vaccine is expected to take a longer time. However, given the emergency situation, SBPL aims to complete the proof of concept in 80 days & complete preclinical development & start Phase I trial by the end of 18-20 months, the DST informed.