Making it in Manufacturing

95% of our viewers aren't following, please check!How do you bring a $400M biotech facility online… without getting automation wrong?This week, in another episode of Making It in Manufacturing, we feature Daniel Shearer, Head of Automation at FUJIFILM, with over 15+ years of experience spanning automation engineering, capital projects, and large-scale biotech manufacturing environments.In this episode, Dan covers:- The $400M multi-modal manufacturing asset at Fujifilm’s Billingham site and what it takes to bring it online- How automation has evolved over the past decade and why data integration is now critical- The importance of standardisation, and how it can reduce cost, validation time, and complexity- Integration challenges across systems like MES, LIMS, and quality platforms- The most common pitfalls in automation projects, and how to avoid themWhether you're building a new facility or scaling existing operations, this episode is packed with practical insights from someone working at the forefront of modern biomanufacturing.👉 Be sure to check out the full episode and learn how to get automation right from day one.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/?viewAsMember=trueSpotify: https://open.spotify.com/show/0kEcRZO...Instagram: https://www.instagram.com/arto.talent...TikTok: https://www.tiktok.com/@artotalent?_t...Apple Podcasts: https://podcasts.apple.com/us/podcast...Website: https://arto-talent.comYoutube: https://www.youtube.com/@artotalentDaniel ShearerHead of Automation at FUJIFILM Biotechnologies LinkedIn: https://www.linkedin.com/in/daniel-shearer-80574b36/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:24 $400M Multi-Modal Asset01:38 Automation Challenges06:59 Standardisation11:18 Integration + Common Pitfalls

Building a CDMO capable of taking therapies from early discovery to commercial supply requires more than scale. It requires scientific depth, operational discipline and a culture that embraces problems rather than avoids them.This week on Making It In Manufacturing, Harry Sloan sat down with Philippe Clavel, CEO of Curapath, bringing decades of experience across pharmaceutical manufacturing, leadership and CDMO strategy.In this episode, Philippe Clavel covers:• The evolution of CuraPath from a university spin-off focused on polymer science to a drug delivery CDMO serving biotech and large pharmaceutical companies (00:00)• Why deep scientific expertise in polymer science and lipid nanoparticles is essential for solving complex drug delivery challenges and improving manufacturing processes (02:29)• How CuraPath transitioned from early-stage discovery work to commercial manufacturing, growing from 0% commercial revenue to roughly 30% within five years (05:14)• The operational realities of scaling into GMP manufacturing, including building robust processes, documentation and training across the organisation (10:12)• Why successful CDMO partnerships are built on trust, technical questioning and understanding the deeper motivations behind a customer’s drug development programme (17:00)If you’re interested in the realities of scaling a specialist CDMO, building high-trust biotech partnerships and transforming scientific innovation into manufacturable therapies, this conversation offers valuable insight from someone leading that journey firsthand.Follow ARTOLinkedIn: / artotalent Spotify: https://open.spotify.com/show/0kEcRZO...Instagram: https://www.instagram.com/arto.talent...TikTok: https://www.tiktok.com/@artotalent?_t...Apple Podcasts: https://podcasts.apple.com/us/podcast...Website: https://arto-talent.com/Youtube: @life_sciences Philippe ClavelLinkedIn: / philippe-clavel-cdmo-gxapis Harry Sloan / harry-sloan-605620154 Timestamps00:00 Introduction00:17 Overview of CuraPath and its drug delivery focus02:29 What differentiates CuraPath as a CDMO04:00 Balancing cost, scalability and complex modalities05:14 Growth from discovery projects to commercial manufacturing06:10 Expanding expertise from polymers to lipid nanoparticle technologies07:41 Supporting customers across the full development journey09:21 The significance of delivering a therapy reaching the market10:12 Transitioning to GMP manufacturing and operational discipline11:34 Challenges that come with scaling CDMO operations13:27 Building a culture that embraces problems and deviations15:27 Understanding customer motivations and building trust18:24 Collaboration across supply chains within drug manufacturing21:17 Maintaining company culture while scaling leadership23:32 Encouraging challenge and empowerment within teams27:13 Advice for business development professionals in CDMO31:08 Future outlook for CuraPath and its pipeline34:25 Personal motivation behind leading the company39:02 Episode closing#MakingItInManufacturing #ARTOTalent #CDMO #PharmaceuticalManufacturing #DrugDelivery #Biotech #LifeSciences

95% of our listeners aren't following, please check!What does it take to standardise an entire industry, and keep pace with AI, cloud, and digital transformation?This week on Making It in Manufacturing, we feature Thana Subramanian, GAMP Global Steering Committee Co-Chair, with over 32 years of experience in idustry, with 25 years as an ISPE member and 15 years as part of the GAMP CoP.In this episode, Thana covers:- The history and purpose of ISPE and its role in advancing pharmaceutical manufacturing- How GAMP evolved alongside regulatory bodies like the FDA and EMA- The benefits of ISPE membership, from networking to access to global best practices- The origins and evolution of GAMP, from early guidance to modern AI-driven systems- The objectives and key themes of the latest GAMP UK Conference, including AI, digital validation, and data integrityIf you’re working in pharma, biotech, or advanced manufacturing, this episode gives you a clear lens into how global standards are shaped — and where the industry is heading next.Be sure to check out the full episode.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/?viewAsMember=trueSpotify: https://open.spotify.com/show/0kEcRZO...Instagram: https://www.instagram.com/arto.talent...TikTok: https://www.tiktok.com/@artotalent?_t...Apple Podcasts: https://podcasts.apple.com/us/podcast...Website: https://arto-talent.comYoutube: https://www.youtube.com/@artotalentThana SubramanianGAMP Global Steering Committee Co-ChairLinkedIn: https://www.linkedin.com/in/thanasubramanian/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:27 ISPE History02:33 GAMP New Good Practice Guide (GxP Process Control Systems) Third Edition07:32 Benefits of ISPE and GAMP

What does it take to turn around a global antibiotic manufacturer and redefine its future in one of the toughest market environments in Europe?This week, in another episode of the Making It in Manufacturing Spotlight Series, hosted by @Thomas McMann we sit down with @Michael Kocher, CEO of @Xellia, who brings over two decades of leadership experience across global pharma and large-scale operations. With a career spanning senior roles in big-pharma and now leading a globally influential API manufacturer, Michael shares a remarkably honest look at the realities, decisions, and opportunities shaping Xellia today. In this episode, Michael covers:- Surprises from his first two years as CEO, including the talent, mindset, and culture he found inside Xellia.- His early strategic focuses, stabilising finances, divesting business operations, and rebuilding a sustainable foundation.- Xellia’s key differentiators, its portfolio of anti-infectives, their role in fighting severe infections and AMR.- The decision to close its Copenhagen manufacturing site over 8-10 years, why the long-term shift was necessary and how it impacts future manufacturing.- European policy and market pressures, reimbursement challenges, OPEX subsidies, and why reshoring isn’t realistic.- Future priorities, financial strengthening, product transfers, market-share growth, and new product launches.- Biggest opportunities ahead, expanding the fermentation-based API portfolio and doubling down on critical medicines. Full Podcast Be sure to check out this episode to hear Michael’s candid perspective on leadership, manufacturing, European policy, and what it truly takes to win in today’s API landscape.Follow ARTO:LinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/YouTube: https://www.youtube.com/@life_sciencesMichael KocherCEO at Xellia PharmaceuticalsLinkedIn: https://www.linkedin.com/in/michael-kocher-191863a/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/

97% of our viewers don't realise they aren't subscribed, please double check, thank you!What does it really take to scale pharmaceutical manufacturing globally, without losing sight of patients?In this standout episode of Making It in Manufacturing, we sit down with Preben Haaning, Board Member at Xellia Pharmaceuticals, and a global pharmaceutical executive with 25+ years of experience spanning sales, finance, site leadership, and board-level strategy.Preben shares lessons from an extraordinary career: including his pivotal years at Novo Nordisk, where he helped scale global manufacturing networks and supported the early foundations of today’s GLP-1 supply chain.In this episode, Preben covers:How Xellia Pharmaceuticals is scaling critical anti-infectives while maintaining reliable global supplyHis unconventional journey from the military into life sciences leadership, and what it taught him about resilience and decision-makingReal-world examples of project success and failure, including moments where patient access was directly at riskWhat it’s like operating as a global pharmaceutical executive, managing multi-site, multi-culture manufacturing networksInside Novo Nordisk’s US expansion, including the launch of its first US-produced drug and early GLP-1 manufacturing challengesIf you’re working in pharmaceutical manufacturing, engineering, operations, or leadership, this is an episode packed with hard-won insight from the front lines.👉 Be sure to check out the full episode and subscribe for more conversations with the leaders shaping life-sciences manufacturing.Follow ARTOLinkedIn:   / artotalent  Spotify: https://open.spotify.com/show/0kEcRZO...Instagram: https://www.instagram.com/arto.talent...TikTok: https://www.tiktok.com/@artotalent?_t...Apple Podcasts: https://podcasts.apple.com/us/podcast...Website: https://arto-talent.comYoutube:    / @life_sciences  Preben HaaningBoard Member at Xellia PharmaceuticalsLinkedIn:   / preben-haaning-18a6193  Thomas McMannDirector - Contracts DivisionLinkedIn:   / thomas-mcmann-05540a10b  Timestamps:02:03 Xellia Pharmaceuticals11:07 From the Military to Life Sciences19:11 Project Success and Failure28:51 Global Pharmaceutical Executive46:41 Novo Nordisk Expansion of US Supply

What does it take to step into a publicly listed CDMO and immediately reposition it for growth in a shifting global market? At Mabion, it starts with people, scientific excellence and a clear commercial vision.This week on Making It In Manufacturing, Thomas McMann sat down with Gregor Kawaletz, CEO of Mabion, bringing over 20 years of experience in the CDMO space spanning leadership roles across NextPharma, Catalent and Recipharm. Now in the first month as CEO, Gregor shares why this move was about broader impact and how the organisation will be steered into its next phase.In this episode, Gregor covers:• The first month as CEO at @Mabion and why “every company is about people” • The transition from Chief Commercial Officer roles into a CEO position with responsibility for the full organisation • Growth priorities, pipeline confidence and an upcoming adjusted business model • The €500,000 innovation initiative and awarding @WPD for novel antibody drug conjugate programmes in oncology • Regulatory shifts in the biosimilar space and how reduced requirements are expanding patient access The conversation also explores operating in a more multipolar global environment and why CDMOs must move beyond traditional fee-for-service models toward deeper collaboration and network thinking.For professionals in biologics, biosimilars or CDMO partnerships, this episode offers strategic insight shaped by experience across NextPharma, Catalent, Recipharm and now at Mabion.Check out this episode to hear how scientific depth, commercial leadership and organisational alignment can reposition a CDMO for long-term success.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@life_sciencesGregor Kawaletz - CEO at MabionLinkedIn: https://www.linkedin.com/in/gregor-kawaletz-276a4830/Thomas McMann - Director At ARTOLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 First month as CEO at Mabion02:19 Two decades in the CDMO space including NextPharma, Catalent and Recipharm02:42 Moving from CCO to CEO05:10 Growth strategy and business model evolution06:57 €500k innovation award and WPD09:41 Biosimilars regulation and market access11:04 Navigating a multipolar global supply landscape12:47 Expanding Mabion’s future offering#MakingItInManufacturing #ARTOTalent #CDMO #Biologics #Biosimilars #LifeSciences #ManufacturingLeadership

What does it really take to build trust in pharmaceutical and biotech partnerships when timelines are tight, expectations are high, and the market never stands still?This week on Making It In Manufacturing, Tom McMann sat down with Alexander Schäfer, Business Development Manager, to unpack what strong execution, honest communication, and long-term thinking look like inside global contract packaging services.In this episode, Alexander shares insights from his work across European operations in pharmaceutical and biotech packaging, supporting everyone from early-stage virtual biotechs to established blue-chip pharma organisations. Speaking from the floor of CPHI, one of the industry’s most important global events, he breaks down how expectations shift across company sizes and why trust is earned through delivery, not promises.Throughout the conversation, Alexander references the realities of operating at scale within global packaging services, the importance of listening to market demand, and how investment decisions are shaped by customer needs and long-term industry trends.In this episode, Alexander Schäfer covers:• How servicing small biotechs versus large pharma companies requires different approaches to expectations and support (01:28)• Why trust in business development is built through execution, consistency, and reputation over time (03:12)• The importance of open communication and solution-led thinking when projects face challenges (04:24)• What skills matter most in business development, including listening, asking the right questions, and understanding customer pain points (06:29)• How major investments into packaging capacity, injectables, and device assembly are shaping the future of the industry (07:21)This conversation was recorded during CPHI, where industry leaders come together to discuss innovation, investment, and the future of pharmaceutical manufacturing. It offers a grounded look at how business development works behind the scenes in a highly regulated, fast-moving environment.If you are working in pharma, biotech, manufacturing, or commercial leadership, this episode offers practical insight into how long-term partnerships are built and sustained.Check out the full episode now.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/YouTube: https://www.youtube.com/@life_sciencesAlexander SchäferLinkedIn: https://www.linkedin.com/in/alexander-sch%C3%A4fer-4515a433/Tom McMannLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Introduction and context from CPHI00:54 Overview of European operations and contract packaging services01:28 Servicing biotech versus pharma clients03:12 Building trust through execution and reputation04:24 Managing challenges with open communication and solutions06:29 Essential skills for business development professionals07:21 Investment in injectables, devices, and future capacity10:25 Closing reflections#MakingItInManufacturing #ARTOTalent #PharmaManufacturing #Biotech #BusinessDevelopment #CPHI #ContractPackaging

The CDMO Changing the Game in Drug DeliveryThis week, in another episode of the Making it in Manufacturing Spotlight Series, we sit down with Ankit Gupta, CEO of Instapill, a company redefining oral drug delivery through freeze-dried, fast-dissolving tablets.With over 15 years of experience spanning investment banking, M&A, and leadership roles in pharmaceutical manufacturing, Ankit brings a sharp perspective on scaling, innovation, and sustainable differentiation.In this episode, Ankit covers:Instapill’s unique FDA-approved non-gelatin ODT technology and why it’s transforming patient outcomes in paediatrics and geriatrics.Scaling up manufacturing capacity in India and future expansion plans into the US, and how automation will maintain quality at scale.How digital transformation and AI are shaping pharmaceutical manufacturing, from paperless R&D to data-driven precision in production.What makes a CDMO attractive to investors, and how sustainable differentiation trumps trend-driven momentum.Lessons from M&A and investment banking, and how they inform his approach as a CEO leading growth in a competitive CDMO landscape.Be sure to check out this episode to hear how Instapill is not only innovating formulation, but reimagining the future of pharma manufacturing.To listen to (or watch) the full episode, search "Making it in Manufacturing Instapill" on your preferred streaming platform. Or, click on the first link in the comments below.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZO...Instagram: https://www.instagram.com/arto.talent...TikTok: https://www.tiktok.com/@artotalent?_t...Apple Podcasts: https://podcasts.apple.com/us/podcast...Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesAnkit GuptaCEO at InstapillLinkedIn: https://www.linkedin.com/in/reachankit/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:11 Stand Out FDA Approval & Speed to Market08:00 Global Growth and Operations10:55 Insights & Leadership Takeaways

Continuous manufacturing is reshaping biologics - and today’s guest is one of the leaders driving that shift.This week, in another episode of the Making It in Manufacturing Spotlight Series, we sit down with Himanshu Gadgil, PhD, CEO of Enzene. With over a decade of experience spanning scientific innovation, biologics development & manufacturing, global expansion and CDMO leadership, Himanshu shares the story behind Enzene’s rise from a small R&D biotech in India to a rapidly scaling global CIDMO with newly established US manufacturing.In this episode, Himanshu covers:- How Enzene built and evolved its first-in-class, fully-connected continuous manufacturing platform, EnzeneX - including initial failures shaped breakthrough innovation.- Why fully-connected continuous manufacturing™ is a cost and efficiency game-changer for biologics.- The regulatory and operational challenges of scaling this technology - and how Enzene approached India-to-US expansion.- Leadership lessons in his progression from scientist to CEO, including culture, resilience, and recognising that success depends on the combination of transformative innovation with a unique values/mission-driven approach to the way business gets done.- The future of biomanufacturing - from localisation and personalised production to fully automated, analytics-driven systems.Be sure to check out this episode to hear how Enzene is redefining what a modern CDMO can be.To listen to (or watch) the full episode, search "Making it in Manufacturing Enzene" on your preferred streaming platform, or click on the first link in the comments below.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalentSpotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talent?igsh=MWdhbWl5N204a253NQ%3D%3D&utm_source=qrTikTok: https://www.tiktok.com/@artotalent?_t=ZG-8tHbGACAZaj&_r=1Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.comYoutube: https://www.youtube.com/@life_sciencesHimanshu GadgilCEO of EnzeneLinkedIn: https://www.linkedin.com/in/himanshu-gadgil-3326307/Thomas McMannDirector - Contracts DivisionLinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:10 Enzene's Vision04:10 Building & Scaling a Global Platform07:51 Enzene's Competitive Edge14:56 The Future of CDMO's21:01 Vision for Enzene's Future Growth