PCI Pharma Services

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

Pharma companies need to become stewards of positive change. Setting goals and aligning high-impact action plans will help drive success. Every company worldwide is expected to reduce its carbon footprint across its operations and supply chain. Alignment with global frameworks such as the SBTi, Race to Zero, or We Mean Business Coalition can enhance the credibility of companies committed to making a positive environmental impact. PCI aims to foster collaboration within the industry to change the perception of pharmaceutical companies' progress and dedication to ESG, ultimately creating a lasting positive impact. In this article originally 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. #ESG #CDMO #LetsTalkFuture

Roller compaction is a crucial process in pharmaceutical manufacturing, offering numerous benefits, especially for moisture- and heat-sensitive compounds. With advancements in technology and a growing focus on specialized medicines, roller compaction is poised to play an even more significant role in the future. Read more from David O'Connell, Director of Scientific Affairs at PCI Pharma Services as he explores the advancements in dry granulation and the fundamentals of roller compaction, presenting it as a viable alternative to traditional wet granulation for producing oral solid dosage forms like tablets and capsules. https://lnkd.in/e28mRkmK #PharmaManufacturing #CDMO #HPAPI #LetsTalkFuture

By implementing a Global Recycling Program, PCI Pharma Services is committed to recycling 100% of recyclable waste by 2030. PCI Pharma's Welsh facilities in Bridgend, Hay-on-Wye, and Tredegar each diverted nearly 100% of their non-hazardous waste from landfills during the first half of FY2024. In celebration of Plastic Free July, we are excited to share that Wales has been named the second-best country in the world for recycling, according to a recent article by BBC News. https://lnkd.in/g5F2HB73 #ESG #PlasticFreeJuly #PlasticWaste #LetsTalkFuture

We are thrilled to announce the successful completion of the Factory Acceptance Test (FAT) for our new state-of-the-art Vial Filling Line at our Sterile Manufacturing and Lyophilization Campus of Excellence in Bedford, NH.   groninger & co. gmbh's cutting-edge system, the integra, marks a significant expansion of our capacity for aseptic vial filling within an ISO-5 cleanroom suite.   The integra, provides flexibility and efficiency in processing pharmaceutical drug products. Operating under a SKAN Isolator, this line impressively delivers a throughput of up to 24,000 vials per hour and batch sizes up to 300,000 vials with 100% in-process control, and includes features to maximize product yield while minimizing waste.   The installation increases capacity using Annex 1-compliant technology, providing large-scale capacity for filling life changing, late-phase clinical and commercial small molecules and biologics – including high-value drug products such as mAbs, oligonucleotides, fusion proteins, and peptides.   #SterileFillFinish #Lyophilization #CDMO #LetsTalkFuture

Early-phase drug product development and manufacturing represent a critical stage in the journey from promising drug candidates to viable, life changing therapies. In the fast-paced world of drug development, collaborative efforts between biopharmaceutical companies and Contract Development and Manufacturing Organizations (CDMOs) have become increasingly prevalent in navigating the complexities of this intricate process. Read our latest article by Jerome Detreille that was published in PHARMAnetwork on CDMO Support: Catalyst for Success in Early Phase Drug Product Development and Manufacturing to uncover the pivotal roles CDMOs can play in de-risking and accelerating early-phase drug development, from formulation to large-scale production: https://lnkd.in/eFx-kmac #CDMO #DrugDevelopment #DrugManufacturing #LetsTalkFuture

At PCI Pharma Services, our highest priority is ensuring that life changing medicines reach those who need them most. Through ongoing investments to expand our capabilities and capacities, PCI's global sterile drug product development and manufacturing network can support all your sterile fill-finish or lyophilization needs. Our renowned experience covers a broad range of modalities, including mAbs, proteins, oligonucleotides, and other biologics, across multiple delivery formats, from vials and bottles to prefilled syringes and autoinjectors. Learn about our integrated large and small molecule solutions from development to commercialization here: https://lnkd.in/g-Gn-AMg #SterileFillFinish #PharmaManufacturing #CDMO #LetsTalkFuture

With the number of clinical trials growing yearly, outsourcing clinical packaging and supply has emerged as an important strategic choice for pharma companies. By partnering with specialized CDMOs, companies can leverage their expertise, state-of-the-art facilities, and streamlined processes to ensure efficient packaging and labeling of investigational drugs. In this article, Rachel Griffiths and Craig LaMarca discuss how outsourcing offers flexibility, scalability, and cost-effectiveness, helping companies adapt to market changes and manage budgets. #CDMO #ClinicalTrialSupply #PharmaOutsourcing #LetsTalkFuture