2-year Backlog in Biologicals Manufacturing Hinders Medical R&D, Development of New Therapies for COVID-19
A shortage of Contract Development and Manufacturing Organizations (CDMOs) has put a severe strain on treating COVID and other post-viral syndromes; especially for products developed for regenerative medicine. Dr. Ian White, President and CSO of Neobiosis, explains how this shortage has caused a 2-year backlog on desperately needed medical technologies.
The demand for biologicals skyrocketed so quickly that supply has not been able to keep pace.
There is a gap between research and manufacturing that has been highlighted by COVID-19. America is in desperate need of more CDMOs to provide the resources to bring about a natural solution to these complex post-viral conditions.
GAINESVILLE, Fla. (PRWEB) August 24, 2021
One area where COVID-19 has had a substantial impact is the development and manufacturing of medicines, medical devices, and pharmaceutical products. The CDMO industry is showing enormous growth and projected to become a $315 billion industry by 2026.(1) However, the demand for products skyrocketed so quickly that supply has not been able to keep pace. According to Dr. Ian White, President and CSO of Neobiosis, a company that focuses on the science of regenerative medicine, demand has caused a two-year backlog of desperately needed cellular and acellular products for the use in research and clinical trials directed at treating the COVID-19 virus and its complications (AKA Post-COVID Syndrome).
“There is a dearth of facilities to manufacture these tissue products. The field of regenerative medicine is sluggish. This has affected research and development, clinical trials, and the production of treatments. Many of the companies working in this area are in need of an external organization to manufacture their product,” says Dr. White.
This backlog in the manufacture of biologicals will have a huge impact on the population. Owen Carhart, co-founder and CEO of Neobiosis, explains this delayed supply will reduce research and decrease the number of clinical trials because organizations will not have reliable access to the materials they need. “Every day, science discovers new ways COVID can affect people long-term. Now, it’s not just that clinicians have to treat the virus, but all the other after-effects and symptoms that will manifest post-COVID,” Carhart says.
Treating COVID-19 and post-COVID Syndrome
People who contracted COVID-19 and now face a protracted recovery time have been dubbed "long-haulers" referring to the length of time following the initial infection these patients still experience symptoms. But as White explains, the true picture of post-COVID Syndrome is continually evolving.
The most common health problems long-haulers have shown include damage to the lungs, heart, liver, and kidneys. Patients also experience fatigue and mental and emotional problems as a result of the vascular and metabolic damage caused by the patient's own immune system in response to infection with the virus. Patients who were treated in the Intensive Care Unit have also shown signs of post-traumatic stress disorder.(2)
Given that there are multiple symptoms and organs being affected, finding an effective treatment is a significant challenge for scientists. Regenerative medicine physicians and scientists, including Dr. White, are looking at how purified amniotic fluid can be used to combat long-term symptoms. Amniotic fluid is the liquid that surrounds an unborn baby during pregnancy, and which is typically discarded following birth.
“This fluid is collected by [American Association of Blood Banks]-accredited and Food and Drug Administration-approved cord blood banks with maternal consent and following extensive infectious disease testing, which is standard for all transplantable human tissue,” wrote Dr. White in a scholarly paper about the use of amniotic fluid to treat COVID.(3)
To this end, White and his team have opened a new CDMO laboratory in Gainesville with the purpose of manufacturing a natural product derived from amniotic fluid. “The use of perinatal tissues in medicine is the result of natural evolution over millions of years. Nature has provided potent tools for the treatment of serious medical conditions. Following extensive testing, we are poised to submit an IND [Investigational New Drug] application with the FDA. Once approved, we can move to clinical trials. We have been successful with our pre-clinical testing of this product, and we are ahead of the curve. Our goal is to shine a light on post-viral syndromes, and hopefully provide a safe and effective treatment where none currently exist,” says White.
Given the shortage of facilities, this new contract manufacturing facility looks to serve as a catalyst not only for post-COVID Syndrome but for other post-viral manifestations. Post-viral syndromes are a disease in and of themselves, explains White, and regenerative medicine may be a solution.
"There is a gap between research and manufacturing that has been highlighted by COVID-19. America is in desperate need of more CDMOs to provide the resources to bring about a natural solution to these complex post-viral conditions," added White.
About Neobiosis
Neobiosis, LLC is a clinical-stage contract development and manufacturing organization (CDMO) run by scientists focused on the science of regenerative medicine. They produce regenerative medicines from perinatal tissues, cells and extracellular vesicles (EVs) for research and clinical trials. Regenerative medicine taps into the body’s innate ability to heal itself relieving pain without opioids, being more cost effective and safer than many surgical alternatives. Neobiosis is an FDA-registered CDMO operating under current Good Manufacturing Practice (cGMP) standards with cleanroom laboratories located in Gainesville, FL. Visit https://neobiosis.com/
1. Newsroom; “COVID-19 Impact on Contract Development and Manufacturing Organization (CDMO) Market”; 19 May 2020; Research Dive; prnewswire.com/in/news-releases/covid-19-impact-on-contract-development-and-manufacturing-organization-cdmo-market-research-dive-814385664.html
2. Chung, Tae; Hosey Mastalerz, Megan; Kole Morrow, Amanda; Venkatesan, Arun; Pfeil Brigham, Emily; “COVID ‘Long Haulers’” Long-Term Effects of COVID-19”; 1 April 2021; Johns Hopkins Medicine; hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid-long-haulers-long-term-effects-of-covid19
3. White, Ian A; “The Potential of Amniotic Fluid-Derived Extracellular Vesicles to Treat Severe Acute Respiratory Syndrome Coronavirus 2 Infections versus Hydroxychloroquine in Human Patients”; 29 July 2020; Epidemiology Open Journal; secureservercdn.net/104.238.68.196/u6s.f87.myftpupload.com/wp-content/uploads/2021/01/The-Potential-of-Amniotic-Fluid-Derived-Extracellular-Vesicles-to-Treat-Severe-Acute-Respiratory-Syndrome-Coronavirus-2-Infection-Versus-Hydroxychloroquine-in-Human-Patients.pdf