Symblosis pharmaceutical srvices
Fast-Tracking Clinical Trials With Sterile Drug Manufacturing Services

The COVID-19 pandemic posed the biggest healthcare crisis for humanity, compelling the pharma, biopharma, and biotech companies to rapidly develop a vaccine to combat the virus. However, developing a vaccine is a lengthy and laborious process that requires years of research and may still result in failure if it isn’t developed in compliance with the regulatory standards or lacks efficacy. On top of that, smaller companies with limited budgets struggle to create a balance between maintaining the quality of their vaccines and ensuring financial sustainability throughout the clinical trials.

UK-based Symbiosis Pharmaceutical Services addresses these concerns by assisting pharmaceuticals, biopharma, and biotech companies in reaching the clinical trial stage faster with their medical products. The MHRA-certified pharma contract manufacturing company (CMO) manufactures advanced therapy medicinal products (ATMP), including various biological drugs and therapeutic and viral vaccines. It deploys sterile manufacturing methods to aid the drug and vaccine development process in compliance with good manufacturing practices (GMP). “We manufacture a range of medical products that are taking biological technology to the next level,” says Colin MacKay, CEO of Symbiosis Pharmaceutical Services. “We have cross-leveraged expertise within the broader drug development space and have applied it to new and emerging viral vaccines and ATMP therapies,” he adds.

Symbiosis combines manufacturing expertise with operational flexibility to deliver the cutting-edge vaccine and drug development services suited to clients’ requirements.

We process vaccines and therapeutic medicines in a highly controlled sterile environment and use aseptic processes to ensure that the microbiological contamination risk is mitigated as far as possible

The company’s short lead times, especially in making its manufacturing slots readily available for medical product development, saves crucial time and money for its clients when approaching clinical trials and accelerates their product release post-manufacture.
Its ability to quickly support the pharma and biotech clients’ medicinal products through the clinical stages enhances their commercial value to prospective partners.

The primary specialty at Symbiosis lies in sterile fillfinish, a process for preparing and packaging medicines such as vaccines that avoids the risk of contamination. “We process vaccines and therapeutic medicines in a highly controlled sterile environment and use aseptic processes to ensure that the microbiological contamination risk is mitigated as far as possible,” explains MacKay. This enables patients to get vaccinated without any additional risks to their health.

The potential value to the industry is perhaps best highlighted by Symbiosis’s ability to offer rapid manufacturing support to the clinical trials of the COVID-19 AstraZeneca vaccine in 2020.Having had previous experience with viral vectors for gene therapy applications, Symbiosis was ideally placed to offer technical, operational and regulatory capabilitiesthat.

were immediately relevant to the ChAdOx viral vaccine platform marketed by AstraZeneca in collaboration with the University of Oxford.
The engagement of Symbiosis provided fast-track access to sterile vaccine drug product manufacturing capacity to enable clinical trial supply, which helped this vaccine become one of the first to gain regulatory authorisation for vaccination against COVID-19.

Aside from the support for the AstraZeneca COVID vaccine, Symbiosis has facilitated the development of many other biological drugs and vaccines in reaching patients through clinical and commercial manufacturing support. The company’s strategic operational philosophy has allowed the firm to assist its clients in obtaining their results fast, even during testing times. Simultaneously, Symbiosis navigated the supply chain and regulatory auditing issues by leveraging its operational flexibility.

In the future, Symbiosis plans to expand its portfolio to further improve the support for the accelerated supply of vaccines and biologics. “We are actively scoping the introduction of more services that are complementary to our core sterile manufacturing expertise,” informs MacKay. Symbiosis will strengthen its sterile handling of viral vector and other cutting-edge therapies to move ahead in that direction. Symbiosis is also keen on expanding its footprint in the UK, as well as developing other international locations to manufacture medicinal products to clients worldwide. Steadily growing with market-driven solutions, Symbiosis will continue to drive value for clients by augmenting the biologic and vaccine manufacturing process.