PCI Pharma Services

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  

The journey from early-phase clinical trials to successful commercial launch for an injectable drug product is complex and multifaceted. Choosing between a traditional vial or prefilled syringe and a modern autoinjector can significantly impact patient experience, adherence, and market competitiveness when considering the delivery system. In this article published by ONdrugDelivery, Jeff Clement and William Welch from PCI Pharma Services explore the emergence of parallel development as a strategic approach to expedite the development process and bring innovative therapies in drug devices such as autoinjectors to market faster. Providing insight in navigating key considerations such as drug product device compatibility, manufacturability and packaging design to allow biopharmaceutical companies to proactively and strategically streamline their clinical to commercial process and ultimately improve patient outcomes. https://lnkd.in/gA2uz2vR #PatientCentricity #AutoInjectors #CDMO #LetsTalkFuture

Jeff Clement recently spoke with Susan Haigney from Pharmaceutical Technology before the 2024 Bio International Convention on incorporating robotics into aseptic manufacturing. They discussed the challenges and benefits of isolator robotic sterile filling based on PCI Pharma Services' experience and expertise at their clinical facilities in San Diego, California, "Using robotics in sterile fill-finish operations provides hands-off aseptic manufacturing…no human interaction with the equipment is great for removing cross-contamination." To learn more on how isolator robotic sterile fill-finish platforms can provide enhanced sterility and quality assurance for your drug product, watch the full interview here:  Robotics in Sterile Processing https://lnkd.in/g8K6S9QR

Major advancements in patient-centric drug delivery present challenges and opportunities in drug product development, manufacturing, device design, clinical trials, regulatory filing, and commercialization. Save your space at our upcoming free knowledge-sharing seminar supporting your patient-centric drug delivery development. Hear from PCI Pharma Services Jerome Detreille, William Welch & Justin Schroeder, and Ralf Kuenzi of Ypsomed AG, Martin Gabler of Körber Pharma, who will discuss the critical success factors required to ensure the success of injectable products throughout their lifecycle. Be sure to stay for our buffet dinner and social networking event! Date: Tuesday 18th June 2024 Basel Marriot Hotel Switzerland Seminar details and full agenda: https://lnkd.in/eae9YN5j #CDMO #BioTech #PatientCentricity #LetsTalkFuture

BIO International Convention 2024 is in full swing. Meet the PCI Pharma Services team this week at Booth#6050 to learn more about the scalability of our aseptic sterile fill-finish robotic service offerings and downstream injectable packaging solutions. From robotic isolator filling platforms supporting clinical supplies to ongoing investments and expansions in large-scale isolator vial filling, lyophilization, and patient-centric injectable packaging, we look forward to discussing how we can support you in delivering life changing therapies. #Bio2024 #BioTech #BioPharma #LetsTalkFuture

As biopharmaceutical companies pioneer new molecules and treatments, it is evident that the stability of these molecules is becoming a detrimental factor with every iteration and that lyophilization is the pathway to a solution.   At PCI Pharma Services, we believe lyophilization cycle development is not only a science but an art. Each drug product that comes into our laboratories presents unique challenges, and the design of a cycle requires an understanding of individual chemistry, characteristics, and interactions to yield a high-quality product.   Read our latest case study to learn how we partnered with a small US-based biotech client to develop a strategic three-part lyophilization cycle development plan for their labile monoclonal antibody to address not only their short-term objective of advancing the product into the clinic but also to plan for the later stage clinical trial program and ultimately commercialization.   https://lnkd.in/gsR8MKHR   #Lyophilization #Biotech #CDMO   #LetsTalkFuture

According to Grand View Research, the global pharmaceutical CDMO market was estimated at $146 billion in 2023 and is projected to grow at a CAGR of 7.2% from 2024 to 2030.   CDMOs play a crucial role in the development and manufacture of today’s drug products and continue to invest in providing specialized services and capabilities to meet the demands of today’s advanced therapies. In the recent edition of Contract Pharma, Jeff Clement discusses PCI Pharma Services global strategy to enhance sterile fill-finish capabilities and capacities. This includes the development of a new 50,000-square-foot multi-product facility, enabling the expansion of services as a global CDMO. The aim is to provide best-in-class late-stage clinical and commercial scale, fully isolated vial filling and lyophilization solutions to both new and existing clients. Read the full article and learn more about the key areas of investment and gain insight into recent sterile fill-finish and injectable packaging expansions to secure our client supply chains: https://lnkd.in/eJDvmMrs #CDMO #SterileFillFinish #PharmaManufacturing #LetsTalkFuture

Defining your device strategy to succeed at patient-centric drug delivery. It all begins with the patient and determining the optimal administration process for the drug product and its characteristics. Assuming the objective is patient self-administration, reaching early decisions on the primary container and device strategy during the clinical phase ensures minimal changes as the product progresses to commercialization, reducing program risk and optimizing time and cost efficiencies. Join PCI Pharma Services William Welch and our guest speaker Ralf Kuenzi from Ypsomed AG to discover: • Key considerations for drug-device combination product design • Pursuit of device innovation vs established platforms • The importance of early pack design, as well as labeling, for your injectable drug product and laying out key interconnected milestones for drug delivery and packaging development • Opportunities for sustainability at critical decision points • ISO requirements for developing and testing your device Full agenda and to register for our upcoming European knowledge-sharing seminar: https://lnkd.in/eae9YN5j #CDMO #BioTech #PatientCentricity #LetsTalkFuture

Every company worldwide is expected to reduce its carbon footprint across its operations and supply chain. Pharmaceutical companies have the added challenges of a restrictive regulatory environment and a need for cohesive ESG standards. However, it is possible to overcome these challenges. In this article published by ONdrugDelivery, Gigi Bat-Erdene, Global Program Manager at PCI Pharma Services, discusses the steps that PCI Pharma has taken to realize its environmental social governance targets and reduce its greenhouse gas emissions in its journey towards net zero. Full article: https://lnkd.in/ebgE8ka3 #ESG #CDMO #LetsTalkFuture