Conducting well-designed structured studies is important when formulating any vaccine.  For live viral vaccines, some challenges include limited analytical tools and inherent variability that make evaluation difficult.  While most viral vaccines are a liquid presentation, the product may not be stored as such, being frozen, lyophilised or even dried.  When properly formulated and stabilised, a product should retain potency and efficacy for years if stored appropriately.  Knowing the stressors triggering instability and designed approaches for evaluation provide a firm foundation for sound formulation and will be discussed. 

mRNA technology offers a great deal of versatility and have come of age during this pandemic era. The success of mRNA-based COVID-19 vaccines has created a significant level of interest for disease prevention and treatment. Promising clinical results for mRNA vaccines against SARS-CoV-2 have implications that go far beyond the current pandemic and bode well for similar approaches in the fight against cancer, heart disease and other infectious diseases. A crucial bottleneck to overcome for mRNA vaccines would be in the manufacturing arena. This talk will explore foundational elements of the mRNA manufacturing workflow, examine key facility design considerations and delve into possibilities of a templated process.

The synthetic DNA vaccine INO-4800 is being developed as a medical countermeasure to prevent COVID-19. INO-4800 is administered to the skin using electroporation technology to enhance the immune response in recipients against SARS-CoV-2. Preclinical studies in mice and nonhuman primates have demonstrated vaccination with INO-4800 protects against disease caused by challenging the animals with high doses of the SARS-CoV-2 virus. Clinical studies are currently ongoing and have revealed the INO-4800 induces broad immune responses which neutralize the virus. Importantly, INO-4800 has a very favorable safety profile, and the thermostability of the synthetic DNA allows for simplified global distribution and storage.

RNAimmune has developed a third generation mRNA vaccine which targets most known mutations. The principle of RNAimmune's proprietary technology is the use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases. The company applies its technologies for the development of cancer therapies, antibody therapies, the treatment of rare diseases, and prophylactic vaccines.

The emergence of SARS-CoV-2 and the resultant COVID-19 pandemic highlighted the need for both rapid vaccine platform advancement and academic partnership with industry. Advances in genomic surveillance show in real time the virus adapting to the global population. Additional tools will be required using orthogonal approaches to the current wave of vaccine candidates. I will cover the development of a CHO cell produced, recombinant subunit, molecular-clamp based SARS-CoV-2 vaccine and the journey from lab bench to commercial scale production and subsequent redesign.

The COVID pandemic has made society aware of the importance of having appropriate concepts and strategies to prevent the spread of an infectious disease, to treat infected people and to provide preventive treatment. For the area of biotechnological production, the availability of a versatile toolbox comprising different expression systems and generic processing concepts, is the basis for fast and efficient development and availability of high-quality products like antigens or vaccines.

Rapid development of treatments for COVID presents the supply chain challenges with the dual requirements for the supply of vaccines and therapeutic treatments. Key is the ability to rapidly manufacture these costs effectively. This talk considers how the supply chain is responding, where the capacity is coming from, how much it's costing us, and in the end, how many people do we need  treat in the coming years.

Production platforms capable of manufacturing high amounts of vaccines in short time-frames are lacking. Current limitations and complexities in vaccine manufacturing will be herein reviewed, specifically related to process development and analytics implementation, with an outlook into the future. An overview of bioprocess and analytics innovations and technologies designed at iBET to overcome production challenges will be also presented. This includes cell line development (e.g., generation of stable insect cells), upstream processing (e.g., adaptive laboratory evolution to improve production yields), downstream processing (e.g., membrane-based approach to purify influenza VLPs), and analytics (biolayer interferometry technologies to assist production of influenza HA-VLPs).

The scope of this talk will comprise a review of the challenges and opportunities for the CDMO industry as observed from an insider’s point of view as a contract manufacturing subject matter expert supporting the US government. Based upon public information, the talk will focus on the challenges, how some were overcome, and what will remain for 2022 and beyond.

Single-use bioreactors have played a large role in rapid vaccine development and production during this pandemic. Flexible and powerful controls combined with a single-use bioreactor make experiments easier to complete under tight time constraints.  Data collected from micro-scale and bench-scale bioreactor systems at Wageningen University is presented as one recent example of Applikon bioreactors’ use in vaccine development.  

From development to market, vaccines have been moving with considerable speed over the last two years. Continuous improvement in streamlining the development and manufacture of clinical trial material has been a key driver.  This presentation reviews Emergent’s overall drug development focus and timeline reduction from project initiation to GMP manufacturing.

• Integrated offering
• Phase-appropriate processes & systems
• Process evaluation & development scale-up
• Data-driven manufacturing
• Flexible technology transfer

A Zika virus vaccine candidate is currently being developed as an inactivated virus vaccine.  A process has been developed to produce a highly purified virus employing perfusion based cell culture and virus propagation followed by multiple orthogonal purification steps.  Analytical methods have been developed for in-process monitoring and control that ensures  consistent performance at each step. In addition, several challenges encountered in the inactivation of the virus has been address through careful optimization and understanding of the input materials as well as the process conditions.  The process has been successfully demonstrated at-scale achieving consistent performance as well as acceptable kinetics of inactivation and completeness of inactivation. 

Raman deployment in vaccine production is viewed as an essential technology, aimed to increase overall efficiency, quality, innovation, and reliability. With Raman models in vaccine production, efficiency increases with inline process characterization of metabolites and titer in real time which can be viewed from any network laptop/desktop. Additionally, Raman models increases quality by enabling proactive issue resolution and reducing overall risk during new product introduction and tech transfer.

Bioconjugate vaccines, consisting of polysaccharides attached to carrier proteins, are generated enzymatically using protein glycosylation systems expressed in E. coli. Using a novel bioconjugation platform, we are advancing development of bioconjugate vaccines against multiple pathogens; including, Pneumococcus, Klebsiella pneumoniae, and Group B Streptococcus.

Vaccine analysis has relied on techniques that were designed years ago and take time to execute.  Influenza is a classic example with the use of SRID and subjective HA/HAI. The VaxArray platform can quantify both antigens and antibodies in a variety of samples across the vaccine development process. Simultaneous measurement of multiple antigens, from bioprocess to DS to DP, will be presented.  Examples will include vaccines targeting influenza, COVID, and measles/rubella.

Separation of enveloped virus-like particles from other extracellular vesicles is a challenging separation problem due to the similarity of these bionanoparticles. Without simple and scalable methods for purification and analytics, it is difficult to gain deeper insight into their biological function. A two-step chromatographic purification method was developed. The developed method is easily scalable to pilot and process scale and allows a fast accomplishment of this separation within one day.

During the COVID-19 pandemic, vaccines were developed against a novel pathogen in record time yet were fraught with significant distribution challenges. This talk will describe a novel technology, adaptable to different vaccine candidates and its success as a needle-free method for vaccine delivery with minimal cold chain requirements. Case studies with several different vaccine platforms will be discussed.

The future of vaccine development and manufacturing and our ability to defend the global population from disease – those we know and those to come – requires nimbleness and flexibility. Speed and flexibility are at the forefront of life sciences trends. Innovations like rapidly deployable adaptive facilities enable advances in treatments by allowing companies to pivot and adapt to market needs quickly. See how future-facing facility design is changing to enable the rapidly evolving life sciences industry. Learn practical tips and solutions that can support how to make these facilities financially viable and compliant.