Equipping Biopharmaceutical Organisations for Vaccine Manufacturing
Vaccines are a remarkable achievement of modern medicine, one of the most meticulously planned and safe immunisation modalities, and significant combatants in ensuring public health. Vaccines are highly effective in warding off a vast array of harmful diseases by using the body's innate defences and fortifying the immune system. The principle underlying the practice of vaccination is based on the remarkable memory capability of the immune system. Upon administration of one or more doses of the vaccine, the immune system becomes primed to recognise and fight the target pathogen. This leads to protection from the disease for years, decades, or a lifetime and underscores the unprecedented efficacy of vaccines equipping mankind for future health emergencies. Intervention through immunisation prevents 4 to 5 million deaths annually. [1]
Recent years have seen the resurgence of eradicated diseases, endemics and pandemics that primarily affect vulnerable populations like infants, the elderly and immunocompromised individuals. The global landscape is experiencing significant demographic changes accompanied by numerous health challenges. By 2050, the global population of individuals aged 60 and older will double to 2.1 billion [2], profoundly impacting healthcare systems worldwide. Vaccines are thus essential not only for children but also for managing this demographic change, protecting older adults from diseases like measles, diphtheria, COVID-19, influenza, pneumonia, Respiratory Syncytial Virus (RSV), and shingles. Achieving "herd immunity" or "community protection" will also curtail the spread of diseases within populations — preventing millions of deaths globally. With vaccines available for over 20 life-threatening diseases, immunisation is helping people of all ages lead longer, healthier lives.
Historically, vaccines were prepared through live attenuated organisms or inert substances, such as inactivated pathogens, subunits, modified toxins, or recombinant proteins. However, biopharmaceutical organisations today are exploring novel methods in vaccine manufacturing including mRNA vaccines, viral vector vaccines, computational vaccine design,?nanoparticle design for antigen display and more, that promise improved efficacy, swift response, and scalability. The evolution of vaccine development from traditional methods to cutting-edge technologies exemplifies the innovation and improvement in the biopharma industry.
Overcoming hurdles, bottlenecks, and barriers that hinder the production of vaccines?is challenging. Vaccine manufacturing plants are multimillion-dollar facilities using state-of-the-art technologies to mass-produce several billion doses of vaccines annually. The entire process, from production to administration, adheres to two crucial imperatives: the maintenance of purity and potency of the vaccine. To achieve this within the manufacturing facility, an environment adhering to stringent regulations and meticulous monitoring of processes is needed. The inflow of personnel, equipment, and materials needs to be accurately controlled, and each action in the process is meticulously coordinated.
Constructing and commissioning a vaccine manufacturing facility is time-consuming and costly. When demand is high, existing facilities may struggle with limited capacity. Biopharmaceutical manufacturers require modular facilities that can expand, adapt to changing production needs, and be established in remote locations. Strategic partnerships are necessary to navigate this intricate landscape and accelerate vaccine development and delivery.
领英推荐
DDE provides biopharma companies with a full suite of cutting-edge, scalable bioprocessing solutions tailored for vaccine manufacturing. Our turnkey solutions span process development, facility design, construction, commissioning, qualification and validation, comply with global regulatory standards such as FDA, EMA, and cGMP and are designed to respond to dynamic advancements within the biopharmaceutical sector. Our flexible, versatile and modular systems allow seamless switching of production processes from one vaccine to another — enabling quicker response to pandemic-like situations. DDE’s meticulous project planning — facilitated by a framework of interdisciplinary collaboration — enables precise commissioning and qualification processes. We also provide technical support, training, troubleshooting and maintenance services, post-commissioning. This approach underscores DDE's commitment to enhancing global health outcomes by accelerating time-to-market for novel vaccines.
Source: