Drug Development Continues Amid COVID-19
The research community persists through this pandemic for the sake of patients waiting for therapies. We are proud to assist your efforts with a full range of development support.
Coronavirus Services by Modality
What are you working on? Explore the drop-downs below to find the support you need for your program.
On the hunt for an antiviral therapy? From target identification and hit finding through lead optimization and safety assessment, there’s much to do, and the faster you can complete it, the better. We can help.
Our partnerships with Distributed Bio gives you access to a developable therapeutic antibody library plus their antibody optimization technology, and with Fios Genomics, AI to mine existing data to repurpose and accelerate treatments.
In Vitro Screening
Use in vitro assays to screen for antiviral compounds before moving to testing efficacy in in vivo models. Depending on your antiviral’s mechanism of action, these can be added at different points in the study – before, during, or after viral infection of cells, or pre-incubation with the virus before infecting cells. Relevant screening includes:
- Expedited in vitro antiviral assay to screen novel and existing antiviral therapies against a set of virus strains
- Positive hits testing against the BSL-3 SARS-CoV-2 pandemic strain
Vaccine development is a lengthy process that you can accelerate by working with a single team that offers full support from efficacy through safety and an intimate knowledge of regulatory guidelines. Our coronavirus vaccine-specific services include:
- In vivo protection studies in mice: immunization and challenge tests, including coronavirus challenge models (HSV-1 and respiratory syncytial virus)
- In vitro and in vivo immunogenicity testing
- Immune profiling, mechanism of action studies
- In vitro assays (cell-based assays and cytotoxicity assays)
- Vaccine candidate toxicity studies, in compliance with GLPs (up to BSL-3 containment through established partnerships), including:
- Evaluation of the immune response against the antigen and the vector
- Biodistribution/shedding studies for viral vector-based vaccines
SARS-CoV-2 and other respiratory viruses, in some individuals, drive an immune response which leads to tissue damage and loss of tissue function. Whether you are developing a new therapy or investigating a repurposed immunomodulatory compound, you can best assess efficacy in models that recapitulate the features of viral-driven immunopathology. Ours include:
- Influenza challenge model:
- Respiratory pharmacology models for the evaluation of acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) and influenza
- Lung LPS PD model
- Influenza challenge model:
Coronavirus Testing for Your Animal Models
Protect your research with animal health monitoring. Since detection of Sarbecovirus in humans is a recent phenomenon, it is unclear if the virus is present in other species. Our team has developed a novel Sarbecoviruses PCR Assay that effectively detects circulating human and known animal coronavirus strains and will likely detect novel coronavirus in other species.
Additional Support for COVID Programs
Read on to discover extensive support for your ongoing discovery and development endeavors.
The goal of your development program is to achieve regulatory approval of your therapy. There are many providers to choose from, but with so much at stake, it’s best to go with partner who specializes in investigational new drug (IND) programs, one with a proven track record.
Our team has contributed to 85% of the therapies approved by the FDA in 2019 and continues to work on our clients’ IND-enabling programs for:
- Vaccines: rodent, rabbit, and risk mitigation strategies
- Gene therapies/oligonucleotides: rodent and large animals
- Monoclonal antibodies: rodent and large animals
CLINICAL SUPPORT SERVICES
Every stage of your development program depends on quality data. Get comprehensive analytical support from discovery to the clinic, manufacturing, and beyond.
- Clinical sample analysis
- Human vaccine studies: PK, biomarkers, cellular and humoral immune responses
- Cell bank characterization
- Stability storage and testing
- Lot and final drug product release testing
- Biosafety and clearance studies
- SARS-CoV-2 PCR Assay – Available June 2020
This assay is designed to screen critical process materials like cell banks or bulk harvests in the production process of biopharmaceuticals for SARS-CoV-2, based on protocols recommended by US CDC, EU agencies, and WHO and optimized for test item specifics.
- Clearance or inactivation studies (analyzing efficiency of inactivation procedures)
Two model virus test systems (BSL-2) – Available June 2020
- Porcine hemagglutinating encephalomyelitis virus (PHEV)
- Human coronavirus 229E
- SARS-CoV-2 PCR Assay – Available June 2020
- Bioactivity and potency testing
- Clinical sample analysis
MANUFACTURING AND SUPPORT SERVICES
Ensure the safe manufacture and accelerate the release of your COVID-19 drug therapies and vaccines:
Rapid, accurate, and robust quality control test methods:
Which research animals are at the highest risk of having a Sarbecovirus or acquiring from another host?
Some animal species may have virus receptors that are more susceptible to SARS viruses, but natural transmission from human to research animals has not been reported and is considered unlikely. These species include nonhuman primates, dogs, cats, swine, ferrets, and bats. Research rodents are unlikely to be infected through natural transmission, although infection through high titer inoculation of mice has been demonstrated. Awareness of Sarbecoviruses as a recent phenomenon; it is unclear which other members of this subgenus may be present in other animal species.
Should routine testing of study animals be performed?
Routine testing of laboratory animals is not recommended. There have been no reports of natural infection in research animals. In addition, standard industry practices of good hand hygiene, use of site uniforms, and appropriate PPE (gloves, face masks, etc.) should be sufficient to minimize possible spread from asymptomatic staff to research animals.
When should clinical cases be tested for COVID-19?
In line with governmental and national organizations (CDC, USDA, AVMA), testing of animals is discouraged unless all other, more common causes of illness have been excluded. Further guidance on the decision to test animals is available from the CDC.
What is the difference between BSL-2 and BSL-3?
BSL is the biosafety level at which a microorganism must be handled, the BSL levels are used to identify the protective measures needed to handle a microorganism safely to protect laboratory staff, the public and environment and prevent anyone becoming infected, they range from BSL-1 (lowest risk) to BSL-4 (highest risk).
Briefly, BSL-2 laboratories can study moderate risk infectious agents that pose a risk if inhaled, swallowed, or exposed to skin, laboratories must have the appropriate equipment in place to allow safe handling of such organisms.
BSL-3 laboratories can handle infectious agents that may be transmitted through the air and can cause a lethal infection, all experiments are carried out in biosafety cabinets designed to prevent infection alongside other safety measures. SARS-CoV-2 is designated a BSL-3 microorganism, whereas the coronavirus strains OC43 and 229E can be handled in BSL-2 laboratories.
What is a cytokine storm?
A cytokine storm can occur when immune and other cells such as barrier epithelium are triggered by bacteria or a virus to produce cytokines in an excessive and uncontrolled manner. This can drive uncontrolled inflammation resulting in damage to the tissue locally and sometimes spread of the cytokines throughout the blood impacting on blood vessel integrity and function of other organs. Such uncontrolled production of cytokines and immunopathology can seriously affect the ability of organs, such as the lung, to function normally and, in the worst case, can be fatal.
What is a protection study?
A protection study assesses the ability of a vaccine/adjuvant combination to protect an animal from challenge or infection with the virus of interest. Vaccination regimes will be designed to suit each vaccine. Readouts will primarily be a reduction in clinical scores and viral titers following challenge and can also include an assessment of T cell and B cell responses following vaccination and after challenge.
What is a challenge model?
A challenge model is where an animal is challenged or infected with the virus of interest. The ability of antiviral drugs or therapeutic neutralizing antibodies to control and limit infection can then be assessed by measuring clinical scores and viral titers. In some cases where the viral infection may result in immune mediated damage of the infected tissue, immunomodulators can be assessed for their ability to limit tissue damage and control the immune response via assessment of cellular responses and cytokines in the relevant tissue or draining lymph nodes.
What can we do to accelerate process development and prepare for production?
Utilizing rapid, objective methods for in-process control testing and creating sound environmental monitoring programs backed by accurate microbial identification can ensure speed to market safely after approval and during full production.
How can companies plan to meet increased demand and mitigate drug shortages?
Implementing rapid microbial detection technology and bacterial endotoxin tests that produce confident testing and accurate results, and outsourcing quality control testing such as microbial identification can be effectively implemented to match the speed of development with the speed of product quality testing.