PCI Pharma Services

Early commercial engagement in the drug product lifecycle is becoming an increasingly important aspect of a successful, timely commercial launch.    By engaging the advice, expertise, and services of your chosen commercial CDMO partner early, ideally, during Phase II to III, you can ensure that processes involving long lead times are factored in, with adequate research into the drug delivery platforms and their specific technical requirements.   In this article PCI Pharma Services’ Paul Smallman outlines the industry trends in commercial packaging and offers important advice on maximizing the chances of success, and also examines real-world case studies based on front-line experience in this field.     #CDMO #CommercialPackaging #PharmaOutsourcing   #LetsTalkFuture

Don't miss out! HomeLab to HomeRun in Clinical Supplies is an upcoming PCI Pharma Services hosted event. More details here: https://lnkd.in/dAM63VZ8 This is an excellent opportunity to gain valuable insights into how the early stages of drug development, planning for clinical trial supplies, and distribution strategy are critical - but often overlooked. Hear from industry expert Derek Truninger, General Manager of PCI Pharma Services, San Diego, as he explores the key considerations and importance of early planning for your #OSD and #injectable clinical trial packaging and distribution strategy. Date: August 29, 2024. Time: 4:00 PM. Location: Center for Novel Therapeutics, 9310 Athena Circle La Jolla, CA 92037, with food and drinks reception from 4:30 PM - 6:00 PM. #LetsTalkFuture #ClinicalSupplies #ClinicalPackaging #ClinicalDistribution #CDMO

First Human Dose (FHD) studies represent a pivotal juncture, packed with complexities yet essential for advancing patient safety and drug efficacy. FHD early-stage clinical trials aim to establish safety and refine the dose to minimize adverse events (AEs) with potentially some indication of efficacy. Traditional drug development pathways for solid oral formulations are often characterized by their transactional nature, contributing to prolonged timelines. Recognizing the critical balance between expediency and safety, PCI Pharma Services and Worldwide Clinical Trials provide an innovative end-to-end partnership designed to navigate the FHD process with unmatched efficiency from drug formulation, and clinical supply through to trial execution and study management. Read the full article that covers the importance of the partnership between CROs and CDMOs and how their individual capabilities have the power to expedite clinical trials and increase efficiency. https://lnkd.in/euxgBgcW #CDMO #ClinicalTrials #SmartFHD #LetsTalkFuture

Press Release: PCI Pharma Services Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection. We are delighted to have successfully completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of our Bedford, New Hampshire, campus. In doing so, we have become the first drug product CDMO to navigate the multi-agency inspection process, a facet of the ICMRA's new Collaborative Hybrid Inspection Pilot (CHIP) program, which is focused on the mutual assessment of facilities that manufacture therapies under the organization's purview. "We're honored to have been selected as the first CDMO to participate in the ICMRA's pilot program, allowing for agencies across the globe to conduct their regulatory approval process simultaneously," said Tom McGrath, VP, Global Quality for Manufacturing & Development at PCI Pharma Services. "The program's collaborative, comprehensive process increases the speed at which CDMOs or sponsoring pharma companies can begin manufacturing, packaging, and ultimately commercializing life-changing therapies." Full Press Release: https://lnkd.in/gWMGK5ua #ICMRA #RegulatoryStrategy #CDMO #LetsTalkFuture

As most of the larger pharma companies have their own Scope 3 net zero targets, they are placing greater emphasis on the ESG credentials and commitments of their suppliers and collaborators. CDMOs need to collaborate with their suppliers and work together to standardize on data gathering and reporting, as well as leveraging new technologies.  Working together with sustainability assessors, ESG-focused technology providers, or supply chain advisors, as well as logistics and packaging companies and their customers, CDMOs have a key role to play in making pharma logistics and supply chain management more sustainable. Rachel Griffiths, Director of Technical Services & Gigi Bat-Erdene, Global ESG Program Manager PCI Pharma Services discuss sustainable pharmaceutical supply chains with European Pharmaceutical Manufacturer magazine. #ESG #Sustainability #CDMO #LetsTalkFuture

Matt Kahle, Sr. Director of New Product Introduction at PCI Pharma Services, provides expert insights into the evolving complexities of project management for bringing new therapies to market.   With more than 20 years of experience in pharmaceutical packaging, spanning various disciplines, including operations, engineering, and project management, my role of ensuring the safety, efficacy, and compliance of the package is critical while also prioritizing a positive consumer experience.   The pharmaceutical packaging sector is experiencing rapid changes driven by technological advancements, delivery methods, and shifting consumer expectations.   While the shifting landscape is moving towards innovative technologies and packaging solutions while maintaining compliance with regulatory requirements, there is a growing focus on sustainable and eco-friendly packaging, with investments in biodegradable materials, recyclable options, and reducing the overall carbon footprint of packaging processes. Additionally, customized and smart packaging solutions are gaining traction, demanding flexible options catering to specific patient requirements and ensuring individual engagement and compliance. The dynamic nature of this evolving landscape demands agile project management methodologies that drive flexibility, rapid response, and continuous improvement enabling teams to respond swiftly to changes in market demands and technological advancements. A partner that comprehends these changes and can navigate them skillfully is essential to saving the customer time and ensuring that products successfully reach the desired market on time and in full. Despite challenges that may arise, understanding those inherent risks and developing contingency plans is crucial for success, necessitating cross-functional collaboration across all disciplines within the organization. PCI Pharma Services is strategically positioned to manage these opportunities, having meticulously planned for and effectively executed strategies to address these evolving needs. It's this foresight and responsiveness to change that puts PCI in a prime position to meet the emerging demands of the industry.    #PharmaceuticalPackaging #CDMO #ExpertInsights   #LetsTalkFuture

In the swiftly advancing realm of patient-centered healthcare, the convergence of drug products and medical devices has created a distinct category known as drug-device combination (DDC) products. Depending on factors such as reimbursement models, strength and user populations, in-home vs. institutional administration and geographic considerations, biopharmaceutical companies may opt to progress several DDC forms for the same product. As part of their device strategy, companies may look to commercialize both autoinjectors as well as prefilled syringes with needle safety devices, and can be considered as a risk mitigation strategy for commercial filing. Uncover more clinical to commercial insights in the latest article by Justin Schroeder, VP of Global Technical Services, published in the Parenteral Technology Supplement 2024. https://lnkd.in/eBUzZhUm #CDMO #PatientCentricity #AdvancedDrugDelivery #LetsTalkFuture

The CDMO industry has boomed in recent decades. To continue providing world-class customer service, leading CDMOs must offer their clients more than the core services of manufacturing and packaging. The provision of non-core support services is what differentiates the good from the great, and sponsors should consider the impact of such services when developing their RFPs. Partnering with a CDMO that is able to provide robust and varied supply chain management solutions is hugely beneficial. It ensures a lower-risk and more efficient supply chain, access to established expertise in a range of essential non-core services, and ultimately achieves greater speed to study and market for your drug product. #CDMO #DrugDevelopment #PharmaManufacturing #LetsTalkFuture

Drug products containing HPAPIs are becoming an increasingly important part of the pharmaceutical outsourcing market, and their growth is showing no signs of slowing down. Bringing HPAPIs into a facility and scaling up through development presents substantial challenges requiring experience and expertise across many fields. In this roundtable report, PCI Pharma Services Kerry Kingdom is joined by industry experts to discuss the complexities of tech transfer and new product introduction in a high potent, multi-product facility. https://lnkd.in/eU2iZmRV #CDMO #HPAPI #PharmaOutsourcing #LetsTalkFuture

Jerome Detreille discusses the $100M expansion at the PCI Pharma Services sterile development and manufacturing campus of excellence in Bedford, NH. The new 50,000-square-foot Sterile Fill Finish facility will provide increased capacity featuring Annex 1 compliant technology, including an aseptic fill-finish line within a fully isolated containment system, complete with twin lyophilizers with automatic loading and unloading systems. The filling line will process batch sizes up to 300,000 vials at a rate of 400 vials per minute (vpm) providing much needed large-scale capacity for the filling of life changing small molecules and biologics, including high-value APIs such as mABs, oligonucleotides, and peptide drug products. Read the full article to learn about key investment areas and recent expansions in sterile fill-finish and injectable packaging. The company plans to increase its global capacity for vials, prefilled syringes, and autoinjectors to secure client supply chains. https://lnkd.in/e6VppWAh #CDMO #SterileFillFinish #Lyophilization #LetsTalkFuture