PharmaSource

In today's fast-paced and competitive landscape, outsourcing has emerged as the lifeblood of the biopharma industry, revolutionising drug research, development, and manufacturing. - 90% of Biotechs rely on CDMOs, so they do not have to invest in their own in-house facilities. The rise of the virtual biotech model, companies which are purely reliant on outsourcing, has accelerated new therapeutic areas. - 80% of Generic drug manufacturing is outsourced to Contract Manufacturing Organisations (CMOs). - 50% of Big Pharma's R&D activities are currently outsourced. This extract from the first module of our new eLearning course, Outsourcing Fundamentals, introduces the importance of outsourcing in biopharma and explains key market terminology. #CDMO #CRO #Outsourcing

🔬 Your weekly CDMO news starts with 3 new CEO appointments: MINAFIN GROUP’s health chemistry division welcomes new CEO, Olivier Ubrich. Benuvia Operations, LLC. appoints Terry Novak as new CEO. Forge Biologics Transition: Timothy J. Miller steps down, John Maslowski named CEO. Forge Biologics have also been selected as AAV partner for MDA’s kickstart program. Serán BioScience adds 8 state-of-the-art suites for late-stage clinical trials. Evonik opens new facility for EUDRAGIT polymers to meet growing demand. MilliporeSigma unveils Mobius ADC reactor for enhanced antibody-drug conjugate production. Vetter Pharma completes 100 clinical batches at Rankweil Site, plans expansion. Strides to establish India’s first specialty pharma CDMO, OneSource. Symbiosis Pharmaceutical Services £26M investment doubles company footprint. Lonza increases mid-scale microbial capacity following Visp facility expansion. Cellares completes first cGMP cell shuttle at New Jersey facility. APL (Apotek Produktion & Laboratorier AB) partners with CurifyLabs to bring 3D-printed medicines to Sweden. Evotec partners with X-Chem, Inc. to enhance early-stage drug discovery. Kincell Bio expands manufacturing capabilities with new cell therapy contract. Somite Therapeutics partners with OmniaBio to advance DMD cell therapy. Recipharm and Hongene Biotech Corporation partner for enhanced gene editing manufacturing. FUJIFILM Cellular Dynamics, Inc expands neuroscience portfolio with iPSC-derived neurons. Boston Institute of Biotechnology CEO receives global CDMO technology leadership award for biologics. #CDMO

School is back in session! 🎓 Over the past year, we have interviewed more than 💯 experts in biopharma outsourcing.   Just in time for 'back to school', we’ve distilled hundreds of hours of best practices from these interviews into 𝐎𝐮𝐭𝐬𝐨𝐮𝐫𝐜𝐢𝐧𝐠 𝐅𝐮𝐧𝐝𝐚𝐦𝐞𝐧𝐭𝐚𝐥𝐬: a new elearning course designed to give you (and your team) a foundation in key pillars of biopharma outsourcing.   This essential 4 hour elearning course will give you: - A comprehensive overview of the strategies shaping outsourced manufacturing   - 10 modules of expert insights and case studies cover Vendor Selection, Contract Negotiation, Tech Transfers, Quality Oversight, Virtual Plants, Sponsor/Supplier relationships, Sustainability, Network Strategy and more   - Video tutorials, downloadable templates, interactive quizzes, and a certificate of completion Who is this course recommended for? - New starters in external manufacturing roles - Supply chain, quality, procurement or legal teams involved with outsourcing - Service providers who want to see outsourcing through the sponsor's eyes   To find out more, follow the link in the comments 👇 PLUS If you’d like our exclusive Back to School discount code, simply comment 'Fundamentals' below and we’ll send you a full information pack. #OutsourcingFundamentals

"What's in it for the CDMO? That's the crucial question." says Eduardo da Fonseca is Head of Supply Chain at Bioeq. Bioeq is a Biosimilars company that uses virtual manufacturing to launch specific products in key markets through a network of external partners. With over five years of experience building their virtual operation from scratch, Eduardo shares invaluable insights for finding the right partners.. those who value you as much as you value them: - Start with strategy alignment: Select manufacturing partners where our products align with their strategic interests - Become the preferred partner: Make operations easier for CDMOs to boost motivation. “The easier we as a customer make the operation at the CDMO, the more they will be motivated to work with us.” - Culture is key: Intentionally build a diverse, balanced team from day one - Navigate challenges: Prepare for price reductions, regulatory complexity, and capacity constraints by optimising operations How are you approaching your manufacturing partnerships? Are you truly creating value for both sides? 🎧 Listen to the full episode: https://lnkd.in/etQ22UsM

🔬 Your weekly CDMO news update from PharmaSource Two announcements from Tanvex this week: Congratulations to Steve Lam, appointed as the CEO of Tanvex Biopharma USA, Inc. https://lnkd.in/eJ3jGcfG Bora Pharmaceuticals invests in Tanvex CDMO,  taking a 30.5% stake. https://lnkd.in/ePncSSjD Olon to boosts API production with Huvepharma Italia acquisition. https://lnkd.in/e9358-wP CoreRx, Inc., Societal™ CDMO , and Bend Bioscience unite under Bend Bioscience brand. https://lnkd.in/ewVpRuvM Merck Life Science achieves industry-first EXCiPACT cGMP certification. https://lnkd.in/eVptvxmp Rokote Laboratories Finland Oy partners with 3PBIOVIAN for GMP production of COVID-19 vaccine. https://lnkd.in/eme_Xy3m WuXi Biologics has completed its first scale-up to 2,000L drug substance (DS) GMP manufacturing. https://lnkd.in/emuenyBJ Rentschler Biopharma launches Lentiviral Vector manufacturing in Stevenage. https://lnkd.in/eTmkcADi Renaissance Lakewood, LLC opens new 67,000 sq ft warehouse at expanded HQ. https://lnkd.in/egBkfD6C Recipharm launches ReciPredict to streamline drug development and manufacturing. https://lnkd.in/etA6TsNR #CDMO

Teva Pharmaceuticals was recently ranked as one of the most sustainable companies in the world + no.1 headquartered in Israel. In the latest episode of PharmaSource podcast Amalia Adler-Waxman explains how they did it. “Sustainability is not just a trend; it’s integral to our DNA,” says Amalia Waxman, SVP, Global Head of Sustainability and ESG and head of Corporate Affairs of International Markets at Teva. “You don't succeed in ESG by doing it to tick a box, fill a report or to satisfy an investor. You do it because you really care about your people and the community.” Teva’s sustainability journey began with a fundamental shift in thinking. “We understood that CSR has evolved to ESG,” Amalia explains. “It needs to be looked at as seriously as we look at our financial performance, by measuring, having goals, and being accountable.” This systematic approach involved several key steps: 1️⃣ Materiality Assessment: Teva conducted a thorough analysis to prioritise the most relevant and important sustainability issues for the company. 2️⃣ Goal Setting: The company established quantifiable goals and metrics to track progress. 3️⃣ Transparency: Teva committed to continuously evolving its reporting to ensure stakeholders understand their efforts in a simple and real way. 4️⃣ Corporate Strategy Integration: Sustainability was elevated from a team initiative to a core part of Teva’s corporate strategy: ESG is everyone's business at Teva. Amalia emphasises the importance of internal advocacy on this journey: “At first it was constant advocacy. When you understand that there are external expectations, it’s very important to use that in a positive way by reflecting back to the organisation what the external stakeholders are expecting of you.” ♻ Listen to the full interview: https://lnkd.in/eBcHawmC #Sustainability

“The only other function in a company that is going end to end is the CEO. Supply chain, by definition, is going end to end, so we need to really understand what is the big picture.” Knut Alicke recently shared his thoughts on why recognizing and developing supply chain leadership is crucial for driving strategic growth and innovation in organizations. Listen in to the latest episode of the PharmaSource podcast to hear more➡️ https://mck.co/3yNhXwa

🔬 Your weekly CDMO news update: FUJIFILM Diosynth Biotechnologies Diosynth triples microbial capacity at £100M Billingham site. https://lnkd.in/gMU2_bue Dr. Reddy's Laboratories and Aurigene Pharmaceutical Services Limited partner with Kainomyx for new anti-malarial drug. https://lnkd.in/gEGXSEUZ PCI Pharma Services completes first ICMRA multi-agency inspection. https://lnkd.in/guwpkCAq Bora Pharmaceuticals completes acquisition of Camden fill/finish site. https://lnkd.in/gUjZUaQg Touchlight to supply dbDNA for Zika vaccine development at University of Nottingham. https://lnkd.in/giPSJFXW Terumo Blood and Cell Technologies and Charles River Laboratories show Finia’s versatility in CGT workflows. https://lnkd.in/gy2KAsH7 Nanoform enters development agreement with Takeda for rare disease therapies. https://lnkd.in/gM-suJbg ViroCell Biologics completes oversubscribed funding round led by First Light Asset Management. https://lnkd.in/gg5F5VPu VGXI accepted into BARDA-supported BioMap consortium. https://lnkd.in/gpNUgRNn PharmaLogic Holdings Corp. and Life Molecular Imaging partner to distribute Neuraceq® in Denver. https://lnkd.in/ghEtnjRi ST PHARM and Quantoom Biosciences partner to enhance RNA manufacturing flexibility. https://lnkd.in/gX8xqvHs #CDMO

"Nobody cares about your fancy facilities if you can't speak the same language as your CMO." Guosheng Zhao, Senior External Manufacturing Lead at LEO Pharma is our latest guest on the PharmaSource podcast. Effective supplier / sponsor relationships are the key to successfully optimising external manufacturing and ensuring consistent medicine supply for patients. That's why finding the right rhythm of communication between internal teams and CMOs is crucial, especially in today’s remote working environment. To enhance remote collaboration, Guosheng recommends: - Weekly work-focused online meetings. - Regular informal “coffee talk” sessions to discuss non-work topics and address any challenges. - Balancing virtual and in-person interactions when possible. "Twice a year, I arrange visits to the CMO, often bringing colleagues from different functions. These face-to-face interactions are essential for building understanding and trust.” Read the full interview: https://lnkd.in/ev_eVjHc

🔬 Your weekly CDMO news update: Congratulations to Owen Murray, apponited as the CEO of Bend Bioscience, CoreRx, Inc., and Societal™ CDMO https://lnkd.in/g-T3ekWd Lonza’s MODA-ES® platform boosts cell therapy manufacturing at Champalimaud Foundation. https://lnkd.in/gSdqQZcH WuXi Biologics partners with Medigene AG for multi-target TCR-TCE development. https://lnkd.in/gPTafGS8 Evotec-Bristol Myers Squibb partnership hits $25M milestone in neurodegenerative research. https://lnkd.in/gK8cB3ST AGC Biologics to manufacture NECVAX-NEO1 at Heidelberg facility. https://lnkd.in/gGbVwt_h Abzena and Angiex Inc. partners as AGX101 enters phase 1 clinical trials. https://lnkd.in/gqiwyfzM Phosphorex expands with NOF CORPORATION LIFE SCIENCE DIVISION investment. https://lnkd.in/gS-VYjxa The Ritedose Corporation increases respiratory drug donations to 1 Million doses. https://lnkd.in/gG8whMMG Taiwan Bio-Manufacturing Corporation, TRACT Therapeutics, Inc. completes @TregCel transfer, phase 2 trial on horizon. https://lnkd.in/gxvYW_r7 CiVentiChem expands manufacturing capacity by 300% with new facility. https://lnkd.in/guufzdzy Evonik partners with KNAUER to enhance LNP scale-up. https://lnkd.in/gQvfHb43 #CDMO