HOW TO FACE THE GLASS VIALS WAVE OF INNOVATION LEVERAGING ON PROCESSES Improving glass vials performances starting from quality by design approach Anna Malori - Bormioli Pharma In order to answer this need, we decided to improve glass vials performances leveraging on the processes behind the product, rather than acting directly on the final product features (i.e., glass composition). This way of intending product innovation re- sults from the QbD (Quality by Design) paradigm, an integrated approach to development, manufacturing and quality, increas- ingly spread across the pharmaceutical market. In our experi- ence, this implied a full commitment at all levels in the technical organization, start- ing from Engineering, Operations, Quality and Technician. The contribution of each function was essential to develop an ad- vanced manufacturing technology and to set up robust controls along the whole manufacturing process. The result is a glass vial product having excellent mechanical performance and optimal chemical, dimensional and thermal stability. Such a superior glass vial positively impacts both patients’ health and pharmaceutical companies, ensuring drug stabil- ity of today’s complex parenterals while minimizing regulatory impact and routine packaging challenges – delamination, leaching, thermal shock, and breakage-. That is why technological advance in manufacturing process can be the key to rethink innovation in parenteral glass vials. References 1. Freedonia (2015), World Pharmaceutical Packaging Industry Study #3269, pp. 73-75 In the world market for parenteral products, glass vials con- tinue to be the most widely used primary containers, mainly thanks to strong barrier properties and a broad range of applications served. This trend is expected to be confirmed also over the next years, with a global demand for this type of container that will reach $5.7 billion in 2024 (1). From the packaging manufacturer standpoint, the increasing demand for parenteral glass vials results in a con- stant need for innovation and product development. If we look at the product development activi- ties carried on by the biggest packaging manufacturers in the world, we can easily identify the innovation drive: improved shatterproof and chemical-resistant properties as well as security features. In a few words, packaging manufacturers are focusing on improving glass vials performances. However, innovating in the parenteral packaging sector means necessarily dealing with the strict regulatory framework for this type of products. The regulatory approval procedures can take years and that is why each single change in the glass vial configuration may be seen as an obstacle towards the final drug product approval. The real challenge that packag- ing manufacturers must face is indeed matching the need for improved glass vials performances with the standardization need expressed by the pharmaceutical companies. HOW THE SHIFT TO COMPLEX, TARGETED CANCER DRUGS IS RESHAPING PARENTERAL DRUG MANUFACTURING Jason Bertola - CordenPharma International the activities of the companies that manufacture injectable oncology drug products. Production in the targeted therapy era The production workflow of modern drugs is more challenging than the dissolve, filter, fill, cap & clamp, and ship process. Now manufacturers deal with complex drugs, and by extension, more challenging formulations. For example, liposomal formulations and antibody drug conjugates are more complex to manufacture than traditional chemotherapeutics. Targeted therapies act on specific molecular targets associated with cancer. As such, they do not provide benefits to all patients. Ultimately, this also affects contract manufacturers by reducing the volumes their customers require. Low volumes and complexity affect the economics of manufacturing. Over the past 20 years, Oncology Drug Product development has experienced significant change. Mass-market cytotoxic agents have given way to more complex, potent, and targeted therapies that serve smaller patient populations. This shift, although good for the patient, has put strains on parenteral drug manufacturing plants. Manufacturers that used to dedicate significant production capacity to products like Paclitaxel, now face the logistical and technical complexity of filling capacity with small volume programs for multiple drugs. The pace of change is illustrated by data from the industry pipeline. Cytotoxic drugs now account for 8% of the cancer pipeline, down from 15% in 2006 (1). Over the same period, targeted biologics’ share of the pipeline rose from 21% to 43%. These pipeline changes have reshaped The packaging innovation drive: improved shatterproof and chemical-resistant properties as well as security features 13 PHARMA HORIZON – vol. 2(2) 2018 Contract manufacturers can expect to see a continued shift toward more complex formulations and potent compound targeted therapies