Making it in Manufacturing

53Biologics is adding new lyophilisation equipment and an isolator to its facilities, completing its fill and finish capabilities so the company is fully end to end. That means the small batches first clinical trials need can stay under one roof.On Newsbeat, live at CPHI Milan 2026, Ruby Collier spoke to Javier Santos, Business Developer at 53Biologics, about the company's new in-house lyophilisation and what it means for customers' clinical programmes.In this episode, Javier covers:(00:33) 53Biologics' new lyophilisation equipment and isolator, which complete its fill and finish capabilities and make the company end to end, in line with its philosophy.(01:05) Why the small batches needed for first clinical trials are so hard to place with outside fill and finish suppliers, and how bringing the work in house removes that bottleneck, especially in phase one.(02:14) How keeping every step with one partner makes customers' projects quicker and more efficient, with no extra contracts and no separate providers' timelines to manage.(03:13) What his conversations at CPHI have confirmed: clients across many projects are asking for the same small batches, so the capability needs to be in place.Watch the full episode to hear why Javier sees having everything under one roof as the answer to the small-batch bottleneck.Register your interest for CPHI Frankfurt 2027 here: https://www.cphi.com/europe/register-attend/?utm_source=partner&utm_medium=referral&utm_campaign=hln27cpw-cl-artoFollow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talentTikTok: https://www.tiktok.com/@artotalentApple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentJavier SantosLinkedIn: https://www.linkedin.com/in/javier-santos-aberturas-96b7a45a/Ruby CollierLinkedIn: https://www.linkedin.com/in/ruby-collier/Timestamps:00:00 Introduction00:52 Why small clinical batches need in-house fill and finish01:58 Simpler projects, everything in one place02:58 What CPHI conversations have confirmed03:52 Closing thoughts#Newsbeat #ARTOTalent #CPHI #CPHIMilan #FillAndFinish #Lyophilisation #Biologics #CDMO

95% of our viewers aren't subscribed. If you're watching and not yet subscribed, please subscribe to the channel so you don't miss future episodes. This week on Making It In Manufacturing, Thomas McMann sat down with Dr Amy Walker, CEO of 4basebio. In this episode, Amy covers: • Why DNA has been made the same way for 50 years, and what changes when you take the bacteria out of the process entirely. • How 4basebio's enzymatic platform works, and why it cuts GMP grade DNA from a 6 to 9 month wait down to under 12 weeks. • What it was actually like joining as the company's first employee, when 4basebio was an empty building on an industrial estate outside Cambridge. • The funding headwinds of the last two years, what happens when a client loses their NIH funding overnight, and how they diversified the client base around it. • Why she believes synthetic DNA disrupting plasmid is a question of when rather than if, and what she wants regulators saying about it in ten years' time. Worth watching if you work anywhere near cell and gene therapy, mRNA, viral vectors or DNA supply. Even if plasmid isn't your day to day, it's a clear look at how an established manufacturing process gets displaced, and what it takes to get conservative buyers to switch. Follow ARTO LinkedIn: https://www.linkedin.com/company/artotalent/ Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ng Instagram: https://www.instagram.com/arto.talent TikTok: https://www.tiktok.com/@artotalent Apple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575 Website: https://arto-talent.com/ Youtube: https://www.youtube.com/channel/UCkoSWF_xqX4i9OIkX4pGaxQ Dr Amy Walker LinkedIn: https://www.linkedin.com/in/amy-walker-4a9785154/ Thomas McMann LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b Timestamps: 00:00 Introduction 01:35 What 4basebio does 02:10 Operating as a CDMO 02:48 Why plasmid DNA hasn't changed in 50 years 04:09 The safety benefits of removing bacteria 04:49 Lowering the dose required 05:23 From 6 to 9 months down to under 12 weeks 05:36 Personalised cancer vaccines 05:53 Touchlight and why there is so little competition 06:25 How mRNA vaccines changed the conversation 07:36 TruePrime and opDNA explained 08:44 Clean rooms no bigger than a podcast booth 09:46 Why cell free is the real difference 10:48 Joining 4basebio as its first employee 12:01 Head of Discovery to COO to CEO 13:09 Balancing the science and the commercial 14:14 The funding headwinds of the last two years 15:37 GMP certification and getting into the clinic 17:00 Persuading big pharma to switch 17:47 The regulatory objection 19:54 The Genezen partnership 20:32 "There was nothing to see. It was an empty building" 23:31 The advantage of having worn every hat 24:41 Where the strongest growth is coming from 26:41 The case for vertical integration 28:46 Sustainability 29:44 Where 4basebio is in ten years 30:49 Quickfire questions #MakingItInManufacturing #ARTOTalent #4basebio #SyntheticDNA #PlasmidDNA #CellAndGeneTherapy #mRNA #ViralVectors #CDMO #Biomanufacturing

Ensera has launched the Ensera Alliance Network at CPHI Milan 2026. It brings like-minded companies together across the value chain, from drug product manufacturing and fill finish to assembly, packaging and serialisation.On Newsbeat, live at CPHI Milan 2026, Ruby Collier spoke to Darren Hieber, VP Alliance Partnerships at Ensera, about the network and what it offers pharma companies.In this episode, Darren covers:(00:26) What the Ensera Alliance Network is: drug product CDMOs, equipment makers and platform auto-injector companies working together, with six groups in so far and plans to expand.(01:41) How the network brings well-respected specialists to a pharma company, so it no longer has to evaluate five fill finish partners and six packaging partners on its own.(02:46) Why early discussions matter, from the year of user and human factors studies after a device is chosen to a full and complete submission to the regulators.(04:03) What Ensera wants to hear from pharma companies at CPHI: referral opportunities, and the pain points the network is built to help avoid.Watch the full episode to hear how the Ensera Alliance Network plans to support patients and customer projects.Register your interest for CPHI Frankfurt 2027 here: https://www.cphi.com/europe/register-attend/?utm_source=partner&utm_medium=referral&utm_campaign=hln27cpw-cl-artoFollow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talentTikTok: https://www.tiktok.com/@artotalentApple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentDarren HieberLinkedIn: https://www.linkedin.com/in/darren-hieber-59517637/Ruby CollierLinkedIn: https://www.linkedin.com/in/ruby-collier/Timestamps:00:00 Introduction01:26 How the network helps pharma02:31 Collaboration across the network03:50 What Ensera wants to hear at CPHI05:01 Closing thoughts#Newsbeat #ARTOTalent #CPHI #CPHIMilan #CombinationProducts #FillFinish #DrugDelivery #PharmaPackaging

For Pep Gubau, AI is ready for pharma manufacturing, and the results are already measurable: one of Aizon's early adopters, a plasma derivatives manufacturer, raised its yield by 4% in three months, worth $30 million. This year CPHI gave AI a dedicated zone of its own.On Newsbeat, live at CPHI Milan 2026, Ruby Collier spoke to Pep Gubau, CEO and Founder of Aizon, about where AI is delivering results in pharma manufacturing.In this episode, Pep covers:(00:31) What a dedicated AI zone at CPHI means to a company that has focused on AI for pharma manufacturing for more than 12 years, and the interest now coming from manufacturers.(02:20) Why the manufacturing floor needs deterministic machine learning rather than large language models, and how digital capacity raises yield and avoids deviations.(04:32) Where language models are useful, where machine learning belongs in GMP, and why, for the first time in his 40 years in pharma, he sees regulators such as the FDA and EMA ahead of the industry.(07:23) Two results: a 4% yield increase worth $30 million in three months for a plasma derivatives manufacturer, and a CDMO that brought its deviation batches down to zero with predictive analytics.Watch the full episode to hear why Pep sees change management as the real work in adopting AI, and showing value as the way to win people over.Register your interest for CPHI Frankfurt 2027 here: https://www.cphi.com/europe/register-attend/?utm_source=partner&utm_medium=referral&utm_campaign=hln27cpw-cl-artoFollow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talentTikTok: https://www.tiktok.com/@artotalentApple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentPep GubauLinkedIn: https://www.linkedin.com/in/jgubau/Ruby CollierLinkedIn: https://www.linkedin.com/in/ruby-collier/Timestamps:00:00 Introduction02:07 How AI is changing pharma manufacturing04:19 Hype versus reality07:09 Results so far and what comes next10:27 Closing thoughts#Newsbeat #ARTOTalent #CPHI #CPHIMilan #AIinPharma #PharmaManufacturing #MachineLearning #GMP

Peptide manufacturing needs to grow to ten times today's output within five years, driven by GLP-1s and other peptide therapies. For Dr. Abdelaziz Toumi, meeting demand on that scale takes alliances built for the whole modality, not for one company.Register your interest for 2027 here: https://www.cphi.com/europe/register-attend/?utm_source=partner&utm_medium=referral&utm_campaign=hln27cpw-cl-artoThis week on Making It In Manufacturing, William Keutenius sat down with Dr. Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions, Lupin's CDMO business, at CPHI Milan 2026, where ARTO was the official podcast partner.In this episode, Abdel covers:(01:44) Why Lupin Manufacturing Solutions did not start from scratch: R&D and manufacturing built over many years, sites approved by the US FDA, EMA and WHO, and the service mindset a CDMO needs, where it is all about speed and time.(03:12) Building a coherent global team with a culture of customer centricity, and why the decisions you make today on modality, chemistry, digitalisation and automation shape the network you will have in five to ten years.(04:32) How a CDMO earns the trust of new customers: listen first, understand the problem, then find a better solution, as with peptides, where the bottleneck turned out to be upstream and downstream as well as in drug substance.(06:04) Why being close to customers in the US and Europe matters, and why business development is only one way to do it: programme management in the same time zone means you can pick up the phone, sit down together and solve problems face to face.(07:54) How the alliance with PolyPeptide works: Lupin's DNA in large-scale chemical synthesis, peptide demand driven by GLP-1s, the need for supply chain resilience, and an arrangement built to help innovators and other CDMOs move fast on building blocks.(11:26) Where Lupin Manufacturing Solutions invests next: scaling its building block business, a new payload-linker investment at its Vizag facility, and deeper work in ADCs and peptides, two areas of hyper growth within its core capabilities.(13:10) The one thing he would change to make the industry better: don't think you can do everything alone. In his words, one plus one equals three.Recorded on the final day of the show, this conversation is a clear look at how a CDMO built on the foundations of a global healthcare company wins new customers and chooses where to invest next. Watch the full episode to hear why Abdel believes events like CPHI exist for exactly this: finding the partners who complement you.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talentTikTok: https://www.tiktok.com/@artotalentApple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentDr. Abdelaziz ToumiLinkedIn: https://www.linkedin.com/in/abdelaziztoumi/Timestamps:00:00 Introduction01:09 Lupin and Lupin Manufacturing Solutions01:44 A CDMO built on Lupin's foundations03:12 Building a coherent global team04:32 Earning the trust of new customers06:04 Being close to customers in the US and Europe07:54 How the PolyPeptide alliance works10:17 What's next for Lupin Manufacturing Solutions11:26 The next investments: ADCs and peptides13:10 One thing to make the industry better#MakingItInManufacturing #ARTOTalent #CPHI #CPHIMilan #CDMO #Peptides #ADC #PharmaManufacturing #PharmaSupplyChain

Onyx Scientific has announced a £1.5 million investment in its Sunderland facility to increase its GMP manufacturing capacity. More suites let Onyx ramp up commercial production while keeping the speed and flexibility its early phase clients need.On Newsbeat, live at CPHI Milan 2026, Ruby Collier spoke to Chris Atherton, Commercial Director at Onyx Scientific, about the investment and what it means for Onyx's clients.In this episode, Chris covers:(00:53) Why more suite capacity lets Onyx meet its commercial clients' growing production needs without affecting the early phase clients who need flexibility and speed.(01:46) The skilled people the investment relies on, across production, analytical, technician and warehouse roles.(02:08) How commercial production, a fairly new step for Onyx since 2021 and the culmination of many years of work, is becoming routine manufacturing.(02:38) Why small molecules remain the bedrock of drug development, and why Chris expects more early phase work over the next year or two as customers secure funding.Watch the full episode to hear how the Sunderland investment supports Onyx Scientific's move into routine commercial manufacturing.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talentTikTok: https://www.tiktok.com/@artotalentApple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentChris AthertonLinkedIn: https://www.linkedin.com/in/chris-atherton-471632111/Ruby CollierLinkedIn: https://www.linkedin.com/in/ruby-collier/Timestamps:00:00 Introduction00:36 Commercial and early phase work01:31 The skills behind the investment02:23 Small molecule demand at CPHI Milan03:19 Closing thoughts#Newsbeat #ARTOTalent #CPHI #CPHIMilan #SmallMolecules #API #GMP #CDMO

Before CPHI Milan 2026, Tom and Elliot put seven questions to each other about what CPHI means, how to make the most of it, and what ARTO is bringing to the show as its official podcast partner.Thomas McMann, host of Making It In Manufacturing, and Elliot Payne, co-founder of ARTO, answer them on a street corner, a rooftop, an arcade and the local pub, one question at a time.In this episode, Tom and Elliot cover:(00:11) Why they're excited for a second CPHI: three days of face-to-face meetings, when most business now happens over Teams.(00:36) What the official podcast partnership means for ARTO: conversations with influential leaders from across the CDMO and pharmaceutical space, content from the show all week, and a panel with three CEOs.(01:29) Advice for first-timers: embrace the chaos, bring your trainers, and make the most of everything happening around the show.(02:28) What a good CPHI looks like for a CDMO: strengthening current partnerships, finding new ones, and building the pipeline for the year ahead.(02:52) What makes CPHI special: everybody is there, the event runs like clockwork, and the booths are built to the nth degree.(04:05) What success looks like for ARTO in Milan, and how the partnership with CPHI builds on it.(04:54) The booths they can't wait to see this year.Register your interest for CPHI Frankfurt 2027 here: https://www.cphi.com/europe/register-attend/?utm_source=partner&utm_medium=referral&utm_campaign=hln27cpw-cl-artoFollow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talentTikTok: https://www.tiktok.com/@artotalentApple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentElliot Payne LinkedIn: https://www.linkedin.com/in/elliot-payne-2a4a917a/Thomas McMann LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Introduction00:11 Are you excited for CPHI?00:36 What the podcast partnership means for ARTO01:29 Advice for first-timers02:28 A good CPHI for a CDMO02:52 What makes CPHI so special04:05 What success looks like for ARTO04:54 The booths to see05:35 See you in Milan#ARTOTalent #CPHI #CPHIMilan #CPHIMilan2026 #CDMO #PharmaIndustry #PharmaEvents #MakingItInManufacturing

For three days every year, the global pharmaceutical industry comes together in one place. For Dr. Abdelaziz Toumi, that makes CPHI much more than a trade show: it is the industry's pulse check.Register your interest for CPHI Frankfurt 2027 here: https://www.cphi.com/europe/register-attend/?utm_source=partner&utm_medium=referral&utm_campaign=hln27cpw-cl-artoThis week on Making It In Manufacturing, Thomas McMann sat down with Dr. Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions, ahead of CPHI Milan 2026.In this episode, Abdel covers:(00:37) Why CPHI is much more than a trade show, and how three days give a pulse check on where investment, customer challenges and manufacturing trends are heading.(02:05) The customer who walked onto the Lupin stand with no meeting booked, needing capacity after an acquisition, and the solution that followed a few months later.(03:05) His panel on API security in a fragmented world, and why geopolitics, supply chain disruption and rising regulatory expectations have made supply security a strategic priority, with CDMOs at its centre.(05:42) What Lupin Manufacturing Solutions hopes to achieve at the show, starting with listening to customers, and its investment in high potency APIs and specialised manufacturing.(07:19) The themes he expects to dominate CPHI: specialisation, strategic partnerships, resilience and speed, and AI.(10:20) His advice for first-time attendees: prepare well, stay curious, and choose quality conversations over a stack of business cards.Recorded before the show, this conversation is a clear guide to what the industry came to Milan to talk about. Listen to the full episode to hear why Abdel believes pharma is, above all, a people business built on trust.Follow ARTOLinkedIn: https://www.linkedin.com/company/artotalent/Spotify: https://open.spotify.com/show/0kEcRZOiJChOoN1KF2n1ngInstagram: https://www.instagram.com/arto.talentTikTok: https://www.tiktok.com/@artotalentApple Podcasts: https://podcasts.apple.com/us/podcast/leading-beyond-the-lab/id1783115575Website: https://arto-talent.com/Youtube: https://www.youtube.com/@artotalentDr. Abdelaziz Toumi LinkedIn: https://www.linkedin.com/in/abdelaziztoumi/Thomas McMann LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/Timestamps:00:00 Introduction00:37 What CPHI is, in Abdel's words01:41 Years at CPHI and what keeps him coming back02:05 The walk-in customer with no meeting booked03:05 Abdel's panel: API security in a fragmented world04:21 Why CDMOs are critical to supply chain resilience05:42 What Lupin Manufacturing Solutions hopes to achieve07:19 The key themes for this year's show08:58 AI in pharmaceutical development and manufacturing09:56 Making medicine affordable beyond the Western world10:20 Advice for first-time attendees11:55 Why pharma is a people business12:24 Closing thoughts#MakingItInManufacturing #ARTOTalent #CPHI #CPHIMilan #CDMO #PharmaManufacturing #PharmaSupplyChain #APISecurity #PharmaIndustry