Making it in Manufacturing

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

CinnaGen is the first company from its region to receive a European marketing authorisation for a biosimilar. Present in more than 40 countries, CinnaGen is now coming to Europe for the first time.On Newsbeat, live at CPHI Milan 2026, Ruby Collier spoke to Haleh Hamedifar, Chairperson of CinnaGen, about the approval and the partners CinnaGen is looking for in Europe.In this episode, Haleh covers:(00:27) Why the European marketing authorisation, the first for a biosimilar from CinnaGen's region, is so meaningful for the company.(00:58) How an integrated model and in-house development let CinnaGen move faster and bring down costs, and why quality has to become part of a company's culture over years.(02:43) The foundations a company needs to compete in a highly regulated market: an integrated system from R&D to market access, people who understand the science and the regulations, and shareholders with a long-term view.(04:42) The partners CinnaGen is looking for at CPHI: reputable sales, marketing and market access partners in Europe, and co-development partners, for example on monoclonal antibodies.Watch the full episode to hear how CinnaGen, with 20 years of experience producing complex biopharmaceuticals, is preparing for Europe.Register your interest for 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/@artotalentHaleh HamedifarLinkedIn: https://www.linkedin.com/in/haleh-hamedifar-06516548/Ruby CollierLinkedIn: https://www.linkedin.com/in/ruby-collier/Timestamps:00:00 Introduction00:43 Lessons from the European approval02:24 Foundations for the European market04:25 The partners CinnaGen wants at CPHI05:48 Closing thoughts#Newsbeat #ARTOTalent #CPHI #CPHIMilan #Biosimilars #Biopharma #MonoclonalAntibodies #MarketAccess

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