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Cell and gene therapies (CGTs) are becoming therapeutic modalities of choice for complex diseases like cancer, autoimmune and genetic disorders etc. In cell therapies, the cells are sourced either from the patient or a healthy donor and are genetically modified to fight diverse disease conditions within the body, whereas in gene therapies, malfunctioning genes in the cells are replaced with a working copy of the gene. With the advent of these advanced therapies, biopharma industry is facing many challenges not only in developing molecules against new hard to target conditions but also in the logistics of scaled up manufacturing. These therapies were in early stages during the past years and logistics of small batches that are often required for clinical trials were sorted out. As these therapies are becoming mainstream, scaling up or scaling out is becoming a challenge to reach more patients mostly due to intricacies of the manufacturing and fill/finish process that differs from conventional drugs. Gene therapy drug products are mostly filled in a traditional manner within an isolator in vials whereas for cell therapies closed processing and filling in either cryo-bags or vials is the current norm. However, as more therapies are getting approved along with the advent of allogenic cell therapies that will have relatively large batch sizes, more innovation, and new products are required for fast packaging needs as they tend to become less efficacious with increased processing times due to their sensitive nature.
<p>Demand is increasing for Daikyo’s sterile, ready to use closure components, known as Daikyo RUV® (Ready to Use Validated) components. Against that background, Daikyo has significantly expanded its packaging component sterilization operations to meet the needs of smaller customers as well as large scale pharmaceutical companies. By adopting an approach that replicates its existing footprint, Daikyo has been able to manage validation risks effectively, while meeting an ambitious timeline for bringing on new autoclave capacity. The result of this expansion is a state-of-the-art facility that triples the company’s previous sterilization capacity.</p>
Small is the new big. Growth in specialty treatments that target smaller patient populations means less emphasis on economies of scale and more focus on adaptable and modular manufacturing.
There is an increasing trend in the pharmaceutical industry for ready-to-use components for a variety of reasons.
Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (<em>freeze-drying</em>) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.
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