Process development
Process development
Process development for
adenovirus vaccine vectors
Advaxia sets global standards in production-focused cGMP.
Over the past decade, Advaxia has taken up the challenge of translating cutting-edge adenovirus research into hands-on manufacturing know-how.
The key insight: adenoviruses as immune instruction carriers
Adenoviruses serve as highly effective genetic vaccine vectors, enabling cells to express antigens that can obtain powerful patient immune responses. Researchers have obtained sound improvements in this area by selecting or engineering vectors never previously recognized by the human immune system, hindering the interference of pre-existent neutralizing antibody arsenal of the patient immune system and therefore enhancing the vaccines efficacy.
Adenoviral vaccines are intrinsically safe, as they are unable to replicate inside the patient, and are an affordable solution for transporting a genetic message to the protein-making apparatus of human cells — carrying instructions on how to construct a portion of an antigen and how to show it to the immune system. This enables the vaccine to “teach” the immune system, improving its capability to activate a “search and destroy” function when it encounters diseases like influenza, Zika, Rift Valley fever and Ebola, as well as various cancer type-associated cells.
Advaxia’s innovation: translating research findings into production expertise
Whereas the above approach has been primarily research-focused, Advaxia has broken new ground in the field by transferring research data into production know-how. More than ten years ago, we began to explore ways of producing this new generation of adenovirus vaccines under cGMP conditions, ready to be delivered to selected clinical sites.
To achieve this result, we went far beyond just scaling up the steps of the research process to a clinical scale — we completely redesigned the entire manufacturing pipeline to incorporate state-of-the-art solutions.
Despite we have always included single-use technologies in our processes, we still strived during the years to improve our pipelines, tending to a “Quality by Design” approach in implementing new solutions, materials and cGMP-compliant instruments. All our efforts have been translated into solid standard operating procedures (SOP) and tested and refined during every step to optimize the overall process yield. We have trained our production staff to maintain consistently high-quality levels in the end product, through an extensive in-process and release test matrix.
Today, we’re able to deliver adenovirus vaccines according to robust, reproducible quality and safety standards that meet or exceed all national and international regulations.
Advaxia’s capabilities in process development
Development and optimization of Upstream/Downstream process
In our process development laboratory equipped with state-of-the-art technologies and GMP-grade materials, we can design the best manufacturing process to ensure safety and efficacy of your product, through a “Design of Experiment” methodology. We will apply our extensive experience working in close contact with your team, to guarantee stable, reproducible and scalable process parameters from small lab up to manufacturing scale size.
Our Upstream team is focused on maximizing cell-line productivity, adapting the cells to grow in defined media to meet your processing requirements.
Our Downstream team is committed to tailor the most effective harvest and purification process on your molecule, reducing processing time, improving purification yield and consistently optimizing the quality of the product.
Pilot-scale batch manufacturing and Toxicology Lot
We can confirm the process by producing pre-clinical, pilot-scale batches up to 20L scale size using the same GMP materials and single-use solutions we employ in the GMP environment. The purified bulk material is ready to be aseptically filled directly in our process development lab and characterized as Toxicology Lot.