Catalent

BioPhorum Drug Substance's face-to-face event in Framingham has now come to a successful close. The session brought together 53 representatives from 25 member organizations from the the BioPhorum Drug Substance leadership team and the ‘Annex 1’ and ‘Microbial Control’ workstream teams. The thought-provoking and productive three-day event created a valuable forum for open discussion, shared learning and constructive challenge across Annex 1, contamination control and drug substance manufacturing. As an opening session, attendees enjoyed a visit to Sanofi’s Framingham site - an ISPE facility of the future award winner - providing valuable insight into facility design, operational decision-making and the realities of running complex manufacturing environments. The openness and expertise shared set a strong tone for the days that followed. A sincere thank you to Cheryl Essex, Cheryl Sawin and Ken Wong (Sanofi) and to the wider Sanofi team for their support during planning, and to Quentin Seemuller and Abner Garcia-Delgado and the broader site leadership team for their outstanding hospitality. Thanks also to the many presenters who delivered high quality case studies, clearly demonstrating how BioPhorum participation continues to deliver real value: Brian Bell (Amgen) – Implementation of global microbiology QC automation Beth Kirschenheiter (Bristol Myers Squibb) – BioPhorum activities in sterile single-use Akihiro Yanagita (Chugai Pharmaceutical Co., Ltd.) and Julia Carrozzo, PhD (Incyte) – DP comparability Leah Frautschy (Denali Therapeutics) – New facility build Michael Hendershot (Eli Lilly and Company) – Annex 1 meets API reality Brittany Cloud (Medexus Pharmaceuticals) – A risk-based approach to raw material expiry extension Stephen Yang (MSD) – Use of model viruses to support viral disinfection qualification Holger Kavermann (Roche) – Annex 1: key learnings and experiences; automating endotoxin testing (KCA and rFC) Anderson Wong and Benjamin Larson (Sanofi) – Particulate: Application-based acceptance levels Hilary Chan, MS (Takeda) – Contamination control strategy: a practical global approach Across the sessions and workshops, the value of bringing leaders and subject matter experts together in person was clear. There is no shortage of ideas where greater industry alignment and collaboration can drive impact. The focus now is on refining how the BioPhorum Drug Substance leadership team translates this into high priority and high value initiatives. If you would like to learn more about BioPhorum drug substance or how to get involved, contact hello@biophorum.com or visit: https://lnkd.in/efcJPetu

Excited to be part of AIS 2026! If you’re attending, stop by and connect with the Catalent team. We’ll be sharing how our expertise in drug substance development and manufacturing supports the advancement of therapeutic antibodies - from cell line development through clinical and commercial scale. Let’s talk about how to move your antibody programs forward, faster. Schedule time with us: https://ow.ly/yg5350Z5zaE #AIS2026 #AntibodyTherapeutics #Biologics #Biopharma #DrugDevelopment #CDMO #Catalent

Watch our webinar titled "Breaking Bottlenecks: Data-Driven Manufacturing and Case Management in Autologous Cell Therapy." As CAR-T therapies continue to demonstrate transformative potential, developers still face significant challenges related to manufacturing complexity, scalability, regulatory compliance, cost control, and supply chain coordination. Explore how data-driven manufacturing strategies and end-to-end case management can help streamline operations, improve efficiency, and support scalable commercialization. Learn how integrated supply chain orchestration and actionable data insights can help unlock greater flexibility, operational visibility, and cost savings across autologous cell therapy programs. Now available on-demand: https://ow.ly/9RNY50Z5iqn #CellTherapy #CART #AutologousTherapy #Biomanufacturing #SupplyChain #AdvancedTherapies #CDMO

Join Medicon Village and Catalent on June 4 in Lund, Sweden for a Science for Lunch session on smarter early-stage decision-making in oral drug development. If your team is navigating candidate selection for small molecules or peptide-based therapeutics, the decisions made before Phase 1 will define how that program performs in the clinic. Getting those decisions right requires the right frameworks, not just good data. Catalent experts will cover how developability assessment, enabling formulation strategies, and PBPK modelling can help teams move from candidate selection to Phase 1 readiness with greater confidence and fewer late-stage surprises. Register by June 2 here: https://ow.ly/vaZz50Z57qW #DrugDevelopment #OralDrugDevelopment #Formulation #PharmaSciLunch #Catalent

Heading to the International Society of Sports Nutrition’s 2026 Conference? So are we!👋 Join our Self-Care team June 17–19 at the Westin Fort Lauderdale Beach Resort to explore how innovative delivery formats are reshaping the future of performance nutrition. Stop by our table to experience creatine soft chews designed for: ✔ Convenient, powder-free performance support ✔ Flexible high-load creatine strategies ✔ Great taste, potable, with low/no sugar options Today’s consumers want performance products that fit seamlessly into their routines, and format innovation is helping brands deliver exactly that. Book a meeting with our experts at ISSN: https://ow.ly/3Slm50Z4Ojj #ISSN2026 #SportsNutrition #Creatine #Nutraceuticals #SelfCare

Decentralized trials are only as reliable as the supply chain behind them. Investigational therapies still need to reach the right address, at the right temperature, on the right day, with the right documentation. For a Phase 2 study in Primary Sclerosing Cholangitis (PSC), Catalent supported Science 37's Direct-to-Patient Site with centralized storage and distribution from its Philadelphia facility. Shipments to participants' homes ran through secure prescription workflows. Returns tied to monitoring visits were managed in the same system. Setup was tailored to protocol-specific requirements and to the needs of individual patients across North America, Europe, Latin America, and Asia-Pacific. In rare disease studies, where every randomized patient counts, operational reliability is often the difference between an enrollment recovery and a stalled program. Learn how Catalent is reducing patient burden: https://ow.ly/uIiL50Z4O4j #ClinicalSupply #CDMO #DecentralizedTrials #DTP #RareDisease

We’re excited to attend the ALS Drug Development Summit and connect with the innovators advancing the future of ALS therapies. At Catalent, our patient-centric Zydis® ODT technology is designed to support improved ease of administration without the need for water, enhanced adherence and deliver a better patient experience. Connect with us at the summit to learn how we can help accelerate your drug development journey and to explore what’s possible, together. Schedule a meeting with our experts: https://ow.ly/Pa4F50Z3bYL #ALSResearch #DrugDevelopment #CNS #PatientCentric #Biotech #Pharma #ZydisODT

Spray drying is evolving far beyond amorphous solid dispersions. From peptides and biologics to poorly soluble molecules, discover how this scalable manufacturing approach is helping overcome key formulation and production challenges in modern drug development. Check out the executive summary to explore the latest applications, opportunities, and considerations shaping pharmaceutical spray drying. Download now: https://ow.ly/hzSp50Z4f51 #DrugDevelopment #Biologics #Peptides #SprayDrying #Bioavailability

Digestive health is rapidly becoming one of the biggest innovation spaces in VMS—driven by GLP-1 companion support and the rise of “fibremaxxing.” The momentum is accelerating: → Soft Chew digestive health sales +68.7% → Gummy probiotic sales +5.6% → 57% of new digestive launches feature Fiber/"Biotic" positioning Consumers want more than digestion support—they’re looking for satiety, regularity, and wellness in formats they enjoy taking every day. Catalent advantage: https://ow.ly/Xp1A50Z3bR8 ✔ Fiber + Probiotic Soft Chews with Bacillus coagulans (2B CFU) ✔Fiber Gummies ✔ Consumer-friendly formats backed by trusted development expertise The opportunity isn’t just gut health - it’s helping consumers build wellness routines that stick. Start your next digestive health innovation with Catalent Self-Care. #DigestiveHealth #GLP1 #GutHealth #Probiotics #Fiber #SoftChews #Gummies #VMS

The Compaction Simulation Forum is coming to Lisbon! Join the Catalent team for an engaging presentation from Iris Duarte and Diogo Gomes Lopes, titled "Correlating Spray Drying Outputs to Downstream Performance Through Predictive Powder Characterization." Learn how early insights into powder behavior can help accelerate development and de-risk scale-up, and ensure your spray-dried product is commercial ready. Schedule a meeting with our team: https://ow.ly/Y4aC50Z3bit #CSF2026 #CompactionSimulation #SprayDrying #PowderCharacterization #ParticleEngineering