14 PHARMA HORIZON – vol. 2(2) 2018 The future of parenteral drug manufacturing Today’s oncology drug development pipeline suggests contract manufacturers can expect to see a continued shift toward more complex formulations and potent compound targeted therapies. Although, companies continue to invest in these capabilities, demand remains strong and is expected to grow. There are over 300 companies with compounds in the clinic, and since many of these are virtual or with limited resource, reliance on CDMOs will continue. For patients, this means safer, more effective therapies. For parenteral drug manufacturers, it means the era of juggling complex, low volume (high cost per unit) projects will continue. References 1. Global Oncology Trends 2017. Available at: https://www.iqvia . com/institute/reports/global-oncology-trends-2017-advances- complexity-and-cost. (Accessed: 27th December 2017) Having flexibility while achieving high utilization rates is the key to success. While older production lines may present a challenge to remain compliant with regulations, justifying an investment/expansion is more complex today. Manufacturers must manage these challenges while meeting customer timeline expectations. With accelerated development pathways removing some constraints on the pace of progress, the onus is on manufacturers not to slow the advance of therapies. The risk associated with the oncology manufacturing development process can be mitigated by applying a Quality by Design (QbD) philosophy to the development program. This yields better understanding of the process and ultimately increases the robustness and strength of the regulatory package. This is critical in a highly potent environment because there is no direct access to drug product, limited visibility and possibilities of interacting (troubleshooting), along with other restrictions to maintain containment. PARENTERAL DRUG MANUFACTURING CHALLENGES Marga Viñes - Grifols International It well established that parenteral drugs and therapeutic fluids require highly controlled, sterile process environments to be manufactured correctly and to current GMP standards. Processing parenteral drugs is extremely challenging and any review of drug recalls over the past 10 years will confirm this. Safety and quality requires a tremendous focus on process and understanding of process technologies as well as an extremely well integrated and aligned quality system backing it up. The process required for preparing sterile products starts with the procurement of approved raw materials, (drugs, excipients etc.) and primary packaging components (containers, seals, labels…) and ends when the sterile product is properly sealed in the container. Each step in the process is controlled and validated carefully to guarantee the quality required. Process validation is an integral part of cGMP requirements, and is intended to ensure the safety of the product One aspect of Grifols’ commitment to quality has been extensive investment in automation technologies to reduce the risk of error and contamination, and increase both operator and patient safety. We have both “Form-Fill-Seal” technology for the production of polypropylene bags and fully automated glass vial filling lines designed to minimize human interactions with drug products. Artificial vision systems (developed in collaboration with Diagnostic Grifols) also enable the automatic inspection of injectable products for particulates, avoiding the potential for human error in this important unit operation Everyone involved in the manufacturing process must adopt the right attitude in order to accomplish all the safety requirements. A parenteral product is not just another item; behind each product there is a patient, and we should never forget this. Our work ethics and responsibility form part of the commitment made by the pharmaceutical industry towards the patient. Parenteral manufacturing products are always a challenging process due to the high cost, pressure from competitors and the requirements of the Regulatory Authorities. This type of products are different from all other pharmaceutical dosage forms mainly because they must be sterile, free from pyrogenic contamination and free from visible particles, even after being reconstituted. It is a complex and costly undertaking to advance a parenteral drug product. To achieve market and therapeutic success, a range of specific requirements is mandatory. This includes category expertise, integrated, aligned resources, advanced and automated aseptic processing systems, operational excellence and a thorough understanding of the market dynamics that effect parenteral drug markets In addition to being a crucial indicator of quality for injectable products, the presence of particulates in finished pharmaceutical products can have significant consequences for patients. Clinical effects can range from minor problems to serious complications and even death. In the US alone, approximately 190 million liters of intravenous fluids are administered to patients each year, and thus particulate matter contamination is a real concern for the pharmaceutical industry. A parenteral product is not just another item; behind each product there is a patient, and we should never forget this