PCI Pharma Services

Drug development is a very lengthy, expensive process, and reports indicate that every day a drug launch is delayed, millions of dollars in revenue can be lost. In a recent interview with Drug Development & Delivery, PCI Pharma Services' David O'Connell, Director of Scientific Affairs, discussed best practices for outsourcing high potency drug product development and manufacturing programs and why choosing a CDMO that can meet all your outsourcing requirements throughout your drug product's lifecycle is important. Read the full interview: https://lnkd.in/egv5fAk5 #DrugDevelopment #HPAPI #DrugManufacturing #LetsTalkFuture

Hear from Austin Roberts, Operations Manager, Sterile Fill-Finish, at PCI Pharma Services' facility in San Diego, as he shares valuable industry insights and how he sees robotic technology shaping the future of GMP aseptic manufacturing. As Operations Manager, Sterile Fill-Finish, at PCI's San Diego facility, my responsibilities include overseeing multiple areas of robotic aseptic filling, including inventory management, formulation, filling, visual inspection, and packaging and labeling of vials, prefilled syringes or cartridges. Our GMP clinical sterile drug product manufacturing and packaging facility in San Diego features gloveless aseptic filling robotic technology. I supported the validation of the robotic filling isolators and other GMP equipment within the Grade C cleanroom. Through this experience, I have become the subject matter expert for the equipment and have established many of the standard operating procedures used throughout the facility. By working closely with the QA, Project Management, and Engineering teams, we ensure GMP compliance and successful operational delivery to meet our clients' needs. As I picture the future of Sterile manufacturing, I see robotic isolators leading the way. There are numerous benefits to using robotic isolators, and it makes sense for the industry to continue developing this technology, which ultimately benefits the patient. Compared to conventional aseptic filling lines, robotic isolators offer many advantages. Operating in a sterile environment with no human intervention reduces the risk of introducing contaminants. The interior of the isolators are decontaminated through vaporized hydrogen peroxide and are designed to supply Grade A laminar airflow, together with ready-to-use sterile components ensures sterility. Drug product quality is enhanced with the use of plastic caps with integrated stoppers, which helps eliminate metal particle contamination. PCI Pharma Services is constantly evolving, creating capabilities and adding science-focused solutions for clients and their life changing drug products. The robotic isolators offer scalable clinical solutions for filling vials, syringes, and cartridges of various sizes to meet the demands of global clinical studies. PCI strives to accomplish customer commitment and flexibility, and the San Diego site can provide this by performing receiving, aseptic filling, visual inspection, packaging and labeling, and distribution all within one building. Adding robotic isolators to our vast capabilities helps us become a world leading CDMO. #AspeticManufacturing #SterileFillFinish #ExpertInsights #LetsTalkFuture

PCI Pharma Services understands the critical importance of your high potent drug product and aligns with your mission to develop life changing therapies. Leveraging over 35 years of experience and advanced containment technology ensures the safe and efficient development of your highly potent medicines. Our versatile, quality-led manufacturing capabilities deliver comprehensive pharmaceutical development and clinical trial manufacturing solutions and prioritize speed to patient without compromising safety.  Integrated and scalable high potent solutions from your world leading CDMO. Together, delivering life changing therapies. Find out more: https://lnkd.in/eXVNeR7t Let's talk future. #CDMO #HPAPI #PharmaManufacturing

ESG-related challenges will take time to overcome in any industry. It's a continuous journey whereby achievements and milestones stand on the shoulders of previous accomplishments.   ESG must be woven into a business's fabric to obtain meaningful progress and tangible results, and several approaches can help. Technology adoption and innovation, including leveraging digitalization and automation trends to help cut energy consumption or material waste. Collaboration with other industries when it comes to complex supply chain processes and global reach — energy, packaging, and manufacturing, to name a few — to develop and hone best practices toward net-zero goals.   Read more from Dr. Kevin Robinson, Manufacturing Chemist, and Gigi Bat-Erdene, Global ESG Program Manager at PCI Pharma Services, on tackling climate science, workforce empowerment, responsible waste management, and supply chain security.   https://lnkd.in/ex-3_MEX #ESG #Sustainability #LetsTalkFuture

Reports estimate that over 500 CDMOs are currently operating worldwide. However, only a small percentage can serve in a consultative capacity and perform non-core, value-added functions alongside the core functions of development and manufacture, clinical trial supply, and commercial packaging. The provision of non-core support services differentiates the good from the great. As the outsourcing landscape continues to evolve, sponsors should consider the impact of such services when developing their RFPs. By imbuing the RFP process with a wider consideration of the full scope of what the CDMO can offer, biopharma companies can maximize their chances of finding a CDMO partner that can provide seamless solutions and reduce vendor management complexity. Read our latest article, Support Services & the Holistic Approach to the RFP Decision-Making Process: https://lnkd.in/eP8eWq5A #CDMO #OutSourcing #BioPharma #LetsTalkFuture

The team behind pci | bridge™ is dedicated to our client's success while advancing the digital platform by offering real-time supply chain visibility across the PCI network.    With decades of collective experience in project management, product adoption, and pharmaceutical supply chain management, the team provides hands-on support to ensure clients maximize their data and receive a personalized experience. Utilizing client interaction and feedback helps the team consistently improve the platform with features to enhance the user experience. Recent feature rollouts have included integrations with Smartsheet and DocuSign, report enhancements, and improved order management. As we look forward to the next year, clients can expect to see new functionality added to pci | bridge™, boosting tracking and reporting features, and giving clients even more power and flexibility.   Learn More: https://lnkd.in/eS5c_fRK #ThePowerOfExperience #LetsTalkFuture #pcibridge.

PCI Pharma Services proudly hosted the recent seminar in Basel, Switzerland. Our team of subject matter experts and industry partners met with clients and prospects and discussed the critical factors necessary to ensure the success of injectable products throughout their lifecycle. Numerous valuable discussions and networking opportunities took place, and we look forward to the next one.   Thank you to all who attended and for making it a successful event. #CDMO #BioTech #PatientCentricity #LetsTalkFuture

Aimee Hodge of PCI Pharma Services recently spoke with Felicity Thomas, MChem, about how leveraging automation advancements in sterile fill-finish can help improve efficiency in aseptic processing and speed up the supply of critical drug products. Automating processes and bringing robotics into aseptic processing, together with single-use systems, is helping to streamline processes, minimizing human intervention and reducing the risk of errors or contamination. Read more In the recent edition of Pharmaceutical Technology on how advancements in automation and robotics are revolutionizing aseptic fill/finish processing: https://lnkd.in/e7GGx3HW #CDMO #SterileFillFinish #BioTech #LetsTalkFuture

With nearly two-thirds of the early-development pipeline coming from small and emerging biopharma, there is a great need to accelerate programs into clinical trials and secure additional funding. At the same time, companies are seeking to de-risk manufacturing operations. Robotic gloveless isolator sterile fill-finish systems address both of these needs.  Jerome Detreille, Derek Truninger, and Peter Kim from PCI Pharma Services met with Pharma's Almanac Editor-in-Chief, David Alvaro, to discuss how the company supports the accelerated timelines of its client partners by providing robotic isolator sterile filling capacity for vials, prefilled syringes, and cartridges at their San Diego, CA, facility to streamline clinical supply chains. Read the interview here: https://lnkd.in/eUQFV-wA #AsepticFillFinish #Robotics #CDMO #LetsTalkFuture

Ed Groleau and Henrik Schlieker of PCI Pharma Services spoke at yesterday's Science for Breakfast event in Medicon Village, Lund, Sweden.   They shared invaluable insights on how the PCI SMART FHD program stands out by offering faster, cost-effective drug development. By offering tailored services covering manufacturing, packaging, stability testing, and regulatory support, SMART FHD redefines efficiency. It streamlines the journey from drug substance to Phase I trials in just six months. With a promise of swift progression to market, authorization marks a transformative shift, setting a new standard for innovation and accessibility.   For more info on SMART FHD Program and Services: https://lnkd.in/gp-W5_QV