PharmaSource

As 2024 draws to a close, rather than making short-term predictions about an uncertain 2025, let's take a longer view with Devyn Smith, CEO of Arbor Biotechnologies and Chairman of the Alliance for Regenerative Medicine. “As you look forward 50 years from now, gene editing and cell therapy will be entrenched modalities, much like small molecules and antibodies are today. It will fundamentally reshape healthcare." He envisions a future where these therapies could tackle diseases of ageing, such as Alzheimer’s. "The future is absolutely amazing for what these types of therapies can do for mankind over the next 50 - 100 years, and beyond.” “We’ll begin to shift from a world of treating symptoms and treating diseases that occurred to actually proactively getting ahead of the game and being preventive.” In the latest episode of the PharmaSource podcast, he shares insights on the promise of cell and gene therapy - as well as the operational challenges the industry must overcome in the short-medium term. 🎧 Listen to the full episode here: https://lnkd.in/em9KdYBy #celltherapy #GeneEditing #CellAndGeneTherapy

You can't outsource accountability. In biopharma's race to market, CDMO partnerships often promise to streamline manufacturing challenges. The reality is: regulators hold Marketing Authorization Holders accountable, period. No regulatory submission has a checkbox for "it was the CDMO's fault." The stakes are clear: - Your company name is on the label - Your patients rely on your promises - Your investors trust your oversight - Your signatures are on regulatory submissions When quality issues emerge, contractual clauses offer little shelter. The impact cascades across clinical development timelines, regulatory assessments and corporate reputation. Essential strategies for maintaining control: 1. Proactive Oversight: Your quality system must extend seamlessly to your CDMO network. Their metrics are your metrics. 2. Clear Communication: Quality issues need immediate visibility. Quarterly reviews are too late. 3. Quality Leadership: Successful CDMO management demands dedicated professionals who understand regulatory expectations across markets. 4. Cultural Alignment: Your quality standards must become their daily reality through consistent engagement and clear expectations. Remember: You're not just outsourcing manufacturing - you're extending your quality system through partners. While success can be shared, accountability remains firmly with you. #Biotech #Pharmaceuticals #Manufacturing #QualityControl

🔬 This week’s CDMO news: Lonza announces “One Lonza” strategy with focus on CDMO business. https://lnkd.in/e_a3AR52 EUROAPI announces leadership changes: new CEO and chair of the board appointed. Emmanuel Blin has been named Independent Chair of the Board of Directors, and David Seignolle assumes the role of Chief Executive Officer. https://lnkd.in/gfiQ-ryp Rocketvax AG collaborates with HALIX to develop next-gen COVID-19 vaccine. https://lnkd.in/gRDQix7d RTI Surgical transforms into Evergen (Formerly RTI Surgical), focuses on regenerative medicine. https://lnkd.in/gKj6ASD3 BioCentriq expands with 60,000 sq. ft. cell therapy facility in NJ. https://lnkd.in/gSs5KBBQ NorthStar Medical Radioisotopes, LLC and Ariceum Therapeutics Partner on Actinium-225 for Cutting-Edge Cancer Therapies. https://lnkd.in/gcV3FEy7 Viva Biotech establishes Boston branch. https://lnkd.in/gAcrGwu5 SK pharmteco unites global brands under one banner. https://lnkd.in/gnnbe8uX Evotec and Novo Nordisk’s LAB eN² selects first Projects for translational drug discovery. https://lnkd.in/g8B-m_ut Porton Pharma Solutions Ltd. partners with Aojin for XDC conjugate drug development. https://lnkd.in/gJHjJPjr Scinai Immunotherapeutics Ltd. establishes U.S. subsidiary for CDMO services. https://lnkd.in/gVM4y_cz Samsung Biologics achieves continued recognition in Dow Jones sustainability index for 2024. https://lnkd.in/gKYMrGxP Upperton Pharma Solutions appoints Lorna Patrick as chief operating officer. https://lnkd.in/gGsiRZwi For the latest CDMO News, sign up to our newsletter:  https://lnkd.in/gHxD3TEJ #CDMO #Pharma #ContractManufacturing

When things are going well you don’t learn much - but when you have failures you learn an awful lot, very quickly. In the latest episode of the PharmaSource Podcast, Stephen Sheehan, Director of External Development & Manufacturing at Alkermes, shares how a three-month development setback became a catalyst for change. Through an intensive root cause analysis, his team developed a comprehensive #CDMO governance framework that transformed their approach to external partnerships. The result? A best-in-class governance model built around 9 critical KPIs that optimise both strategic and operational collaboration. 🎧 Listen to the full interview to discover practical insights on: - Building resilient CDMO partnerships - Implementing effective governance frameworks - Creating sustainable manufacturing practices https://lnkd.in/eBbweMxF --- 𝐎𝐮𝐭𝐬𝐨𝐮𝐫𝐜𝐢𝐧𝐠 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 @ 𝐂𝐃𝐌𝐎 𝐋𝐢𝐯𝐞 Don't miss Stephen Sheehan's interactive roundtable on "Next-Generation CDMO Performance Management" at #CDMOLive. Join the conversation to learn proven strategies for implementing KPIs that drive real results. 👉 Book your ticket here: www.cdmolive.com

We’re excited to announce that PROCOS S.P.A. (CBC Group) will be sponsoring CDMO Live 2025. PROCOS S.P.A. is a CDMO established in 1945, is a wholly owned subsidiary of the Japanese company, CBC Co. Ltd Group, specializing in the development, scale-up and production of Active Pharmaceutical Ingredients (APIs) and Highly Potent Active Pharmaceutical Ingredients (HPAPI), linker-payloads, advanced intermediates, and related services for the pharmaceutical industry. "PROCOS is ready to engage and inspire at CDMO LIVE Rotterdam 2025, bringing over 80 years of CDMO expertise from R&D to manufacturing to the global stage." Simone Manzini, Business Development Manager, Custom Synthesis at PROCOS SpA (CBC Group). Experience the future of contract manufacturing at #CDMOLive, 7-8th May 2025 World Trade Centre Rotterdam. Grab your early bird tickets now: www.cdmolive.com #CDMO

Biotechs will have worked on a drug candidate for years - taking molecules through early trials to hit a target - before it gets to a CDMO. Nikki Whitfield, CEO of Upperton Pharma Solutions recently spoke to the PharmaSource podcast about how important it is to find a team that shares your passion. A chemist by background and self-described "formulator by heart", she has significant experience developing sterile and non-sterile dosage forms for small and mid-sized pharma companies, including a tenure at Quotient Sciences, before taking the helm at Upperton in 2021. Trust is the fundamental element: "It's very difficult to hand your baby over to somebody else to develop. You want to know that they're going to take good care of it, that you're going to remain a priority within the organisation." She advises finding out early how partners handle challenges. "You only know that once you start really working with people and you hit your first bump in the road and see how they respond to that and work with you through that. That gives you everything that you need to know about what's going to happen further down the line." Nikki advises biotechs to look for CDMOs that can: - Match their development speed - Provide necessary technical expertise - Demonstrate flexibility when challenges arise - Show genuine passion for project success 🎧 Listen to the full episode here: https://lnkd.in/dzcm73Nh -- To learn more, ,meet the Upperton team at CDMO Live to discuss how they can support your drug development journey. #CDMOLive #Partnership

Lonza announces new “One Lonza” strategy to focus on CDMO business Lonza has shared its new “One Lonza” strategy, highlighting a simplified organizational structure to enhance its core #CDMO business. The company confirmed its 2024 and 2025 financial outlook, including a planned exit from the Capsules & Health Ingredients (CHI) business. https://lnkd.in/e_a3AR52

📢 We are delighted to welcome Philip Coetzee to the CDMO Live stage at World Trade Center Rotterdam in May 2025. As Director of CMO Management at Daiichi Sankyo Europe,  Philip has extensive experience in optimising complex contract manufacturing networks. Here is what he has to say about the event: “In an environment where time is money, a conference like CDMO Live is the best ever. They created a fantastic platform where information can be shared in roundtables and in quick ‘meet and greet’ sessions with CDMOs to see if there is a synergy.     I will be back next time.” --- 𝐁𝐮𝐢𝐥𝐝 𝐲𝐨𝐮𝐫 𝐟𝐮𝐭𝐮𝐫𝐞-𝐫𝐞𝐚𝐝𝐲 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐧𝐞𝐭𝐰𝐨𝐫𝐤 𝐚𝐭 𝐂𝐃𝐌𝐎 𝐋𝐢𝐯𝐞 Over two high-impact days you will: - Learn from 40+ External Manufacturing experts - Connect with 50 pre-qualified CDMOs - Take part in a series of unique networking experiences + site tour. Early bird tickets are available now: www.cdmolive.com

🔬 This week’s CDMO news: Suven Pharmaceuticals acquires 56% controlling stake ADC specialist CRDMO NJ Bio, Inc. for US$64.4 million.  The acquisition follows Suven’s merger with Cohance Lifesciences earlier this year.  “NJ Bio's capabilities and established customer relationships will accelerate Suven's journey as a global leader in this fast-growing ADC/XDC segment which is emerging as a very important modality and has improved the lives of well over 100,000 patients already." said Executive Chairman, Vivek Sharma. https://lnkd.in/ggkRBH7U Resilience names industry veteran William S. Marth as CEO. https://lnkd.in/gj-49skx Cambrex partners with Lilly Catalyze360 for drug development. https://lnkd.in/gAP_62tR ProBio strengthens leadership team to accelerate growth. https://lnkd.in/gCwB-PbA Charles River Laboratories launches incubator program for early-stage biotech startups. https://lnkd.in/gUtV7RBR NorthStar Medical Radioisotopes, LLC and PDRadiopharma partner for advanced radiopharmaceuticals. https://lnkd.in/gPNHdjKn WuXi Biologics marks major milestones with successful 16,000L PPQ runs and GMP approval. https://lnkd.in/g-CkUmFf Ascendia Pharmaceuticals rebrands as Ascendia Pharmaceutical Solutions. https://lnkd.in/gSHq6UG5 Cellipont Bioservices partners with Xiogenix to enhance client access to advanced filling systems. https://lnkd.in/gThbvVp7 Benuvia Operations, LLC. signs licensing deal with Avernus Pharma for SYNDROS in GCC region. https://lnkd.in/ggrA2qSQ For the latest CDMO News, sign up to our newsletter: https://lnkd.in/gHxD3TEJ #CDMO #Pharma #ContractManufacturing

Site visits? Save the red carpet for movie stars and walk the production line. External Manufacturing pros know that on-site inspections aren't just a checkbox. You need boots on the ground to truly understand a partner's capabilities. Virtual tours and glossy presentations fall short: - They control the narrative - They hide real operational challenges - They mask cultural misalignments Management will always paint a pristine picture. But the real evaluation happens on the production floor, talking to actual operators, not just executives. Benefits of hands-on CDMO evaluation: 1. Comprehensive Assessment: Dive deep into the real operational ecosystem. See beyond manicured presentations to understand true capabilities. 2. Direct Interaction: Unscripted conversations with operators reveal more than any executive briefing ever could. Their body language, casual comments, and workplace interactions speak volumes. 3. Detailed Observation: Unfiltered access lets you spot: - Subtle (or not so subtle) quality control gaps - Potential cross-contamination risks - Cultural workflow dynamics - Equipment maintenance realities Virtual showreels can hide a multitude of sins. Real partnerships are built on unfiltered reality. --- 𝐖𝐚𝐥𝐤 𝐭𝐡𝐞 𝐥𝐢𝐧𝐞 𝐰𝐢𝐭𝐡 𝐮𝐬 𝐚𝐭 𝐂𝐃𝐌𝐎 𝐋𝐢𝐯𝐞 CDMO Live delegates are invited to an exclusive HALIX facility tour showcasing the cutting-edge vaccine manufacturing that was a key part of AstraZeneca’s COVID-19 response. Over two high-impact days at the World Trade Centre, Rotterdam you will meet 50 pre-qualified CDMOs, learn from 40+ External Manufacturing experts, take part in a series of unique networking experiences. Claim your #CDMOLive early bird ticket here: www.cdmolive.com