Beth Cuthbertson’s Post

🤝CDMO INDUSTRY NEWS: BioCina Partners with CelluTx🌟 BioCina, a global leader in biologics contract development and manufacturing, has secured exclusive rights to CelluTx's cutting-edge recombination-based plasmid system (RBPS) for minicircle DNA (mcDNA) production. This advanced technology offers significant advantages, including scalability, high recombination efficiency, higher yields, and simpler purification processes. It produces larger minicircles capable of accommodating complex gene cassettes, enhancing transgene expression and reducing immunogenicity for safer in vivo use. RBPS is set to revolutionize mcDNA production and expand its applications in cell and gene therapies. It's already integral to BioCina's cGMP program for GenomeFrontier's CAR-T product, showcasing its potential in scaling advanced therapeutics. 👏 It's fantastic to see companies growing and driving innovation in the industry! #BioCina #CelluTx #CDMO #Biotech #GeneTherapy #Innovation #MinicircleDNA #Pharma 🌍🧬🚀

🧬The Transformative Potential of Gene Therapy🧪 An interesting read exploring the rapid growth and challenges of gene therapy research, highlighting its potential to revolutionize treatment for rare diseases and beyond. Key takeaways include: 🧫Rapid Growth: Since 2017, gene therapy has advanced quickly, with 14 Phase III trials and 45 early-stage therapies for rare diseases. 💉Major Challenges: Ethical, safety, regulatory, logistical, and cost issues could reduce new U.S. patients treated by one-third from 2025 to 2034. 🔬Regulatory Efforts: The FDA is working to streamline approvals, with initiatives like START to boost rare disease treatments. Only five gene therapies were approved in 2023 out of 2,500 applications. 👩🔬Collaboration Needed: Cooperation among stakeholders is key for efficient trials and faster approvals. 👨🔬Preparedness: Sites need specialized infrastructure and training. Sponsors should support smaller sites financially and operationally. Pre-registering IBCs can save significant startup time. 🚀Patient Role: Patients must be well-informed and committed. Early involvement of advocacy groups ensures alignment with patient needs. Balancing Act: Safety, speed, and accessibility must be balanced through collaboration to overcome barriers and provide timely treatments. #GeneTherapy #MedicalInnovation #ClinicalTrials #RareDiseases #Bioethics #RegulatoryAffairs #PatientEngagement #HealthcareCollaboration #ResearchPartnerships #LifeSciences #MedicalAccess #HealthEquity

💊 NEW CDMO OPENING 💊 📍 - East Coast, USA I am currently partnered with a leading and fast-growing American CDMO offering end-to-end services in formulation & process development, analytical services, and manufacturing including sterile injectable and OSD dosage forms (clinical and commercial). The company is seeking an ambitious and proactive Sales Director on the East Coast to maintain existing accounts in this territory and develop new business. An ideal candidate for this role should possess a successful track record of sales, territory growth, and bringing in new accounts in the CDMO industry. 📩 Please feel free to drop me a message here on LinkedIn or email me at beth.cuthbertson@mackenziestuart.com if you are interested in this opportunity or have any questions. #CDMO #CDMOhiring

👨🔬 NEW CDMO OPENING👩🔬 📍- Japan I am currently partnered with a leading global player in the CDMO industry, providing a range of end-to-end development & manufacturing services for APIs, HPAPIs, drug products, steriles, peptides, biologics, and ADCs. The company is in search of a dedicated Business Development Professional with a hunter-mind-set and an established network to elevate brand presence, identify and foster business opportunities for sustainable financial growth, amplify sales, and build enduring client relationships within the biotech and pharma sectors in Japan. This role offers a competitive salary, with a great compensation package, and a strong progression pathway. The company will also offer full support and a relocation package to fluent Japanese speakers open to moving to the country. 📩 Please feel free to drop me a message here on LinkedIn or email me at beth.cuthbertson@mackenziestuart.com if you are interested in this opportunity or have any questions. #CDMO #CDMOhiring

🚀 New CDMO Partnership Announcement! 🚀 Corden Pharma - A Full-Service CDMO and Certest Pharma have announced a partnership aimed at enhancing lipid nanoparticle formulations with ionizable lipids! 🎉 Certest will provide access to its cutting-edge ionizable lipids platform, backed by comprehensive in vitro, in vivo, and toxicity data. Meanwhile, Corden Pharma, a global Contract Development and Manufacturing Organization, will leverage its cGMP manufacturing capabilities, regulatory expertise, and market access to ensure a high-quality GMP supply for customers. This collaboration aims to revolutionize drug delivery, supporting biotech and pharmaceutical advancements from early clinical phases to commercial production. 🧬💉 This partnership will fill a crucial gap in Corden Pharma's LNP formulation services, providing the missing key element to support biotech and pharmaceutical companies in the development, discovery, and manufacturing of xRNA/xDNA. It complements Corden Pharma’s recently announced strategies to address targeting with peptide-decorated LNPs and enhance mRNA transfection with β-sitosterol. 🌟 As well as this, the partnership augments Corden Pharma’s offerings with a streamlined approach to LNP formulation that also reduces intellectual property challenges in the market. 🌐🔬 #CDMO #PharmaInnovation #LNPFormulation #DrugDelivery #Biotech #CordenPharma #Certest #IonizableLipids #HealthcareRevolution #GMPManufacturing #TherapeuticAdvancements #PharmaceuticalIndustry

Pharma 4.0: CDMOs Digitalize to Enhance Customer Value 🌐 💊🔬A super interesting article exploring the pharmaceutical industry's adoption of Pharma 4.0, a digital transformation framework designed to enhance production processes and accelerate therapeutic innovations. Using advanced digital tools like AI, machine learning, and cloud computing, "smart" plants enable real-time data analysis and automation. The rapid development of the first mRNA vaccine from Pfizer exemplifies the benefits of this data-centric approach. 🤖📊CDMOs and CMOs are at various stages of this digital journey, with leaders like Samsung Biologics offering advanced AI-based services and FUJIFILM Diosynth Biotechnologies optimizing manufacturing through real-time data analytics. 🧬💡Despite the challenges of digitalizing complex and personalized therapies, and the need for secure data management and compliance, digital transformation is crucial for supply chain resilience and efficiency. Supportive regulatory agencies and strategic investments are helping CDMOs enhance product quality and ensure timely drug delivery, positioning them for future success in a competitive market. 🚀 #Pharma4 #DigitalTransformation #CDMO #Biotech #AI #MachineLearning #CloudComputing #SmartManufacturing #PharmaceuticalIndustry #DataAnalytics #mRNAVaccine #SupplyChain #RegulatoryCompliance #TherapeuticInnovation 🖥️

🌟 Big News in CDMO! 🌟 Enzene Biosciences Ltd launches a new Drug Discovery Division, expanding their end-to-end drug discovery, development, and commercialization services across the USA and Asia. 🚀🔬 Key Highlights: -Introducing comprehensive discovery services including antibody services, custom peptides, proteins, and advanced modalities like RNA and exosomes. 🧬 -New state-of-the-art labs in Pune operational by July, with further expansions planned. 🏢🌍 -Enzene’s $50 million New Jersey site opening this summer, featuring the first fully connected continuous manufacturing platform in the US. 🌱 #Biotech #DrugDiscovery #Innovation #Pharma #CDMO #EnzeneBiosciences #ContinuousManufacturing #Biopharma #BiotechNews

🚀 Oncology research is skyrocketing! A super interesting read summarising new analysis from Phesi which shows a 49% increase in global oncology trial investigator sites since 2019, with China seeing an incredible 374% growth. The US still leads, but countries like Korea, Taiwan, Brazil, and Spain are also showing significant gains in this field. This rapid expansion underscores the vital role Contract Research Organizations can play in managing and optimizing these trials. Precise site selection is crucial to avoid overburdening investigators and ensure successful outcomes. #OncologyResearch #ClinicalTrials #CRO #ASCO2024 #CancerResearch #HealthcareInnovation 🌍🔬📊

🌍CDMO INDUSTRY NEWS - Asymchem Group Expands to Europe! 🌍 Asymchem is making waves by establishing its first European manufacturing footprint. They’ve secured the former Pfizer small molecule API pilot plant and laboratories in Sandwich, Kent. This strategic move will enhance their capabilities in clinical small molecule development and manufacturing to meet global pharma demands. 🔧 The development labs will kick off in June 2024, with the API pilot plant following in August. The site aims to employ around 100 people by year-end, including many ex-Pfizer staff. Future plans include adding peptide and oligonucleotide manufacturing, alongside sustainability advancements through continuous flow and biocatalysis. It's fantastic to see companies growing and expanding in this industry, driving innovation and creating new opportunities! 🚀 #Pharma #CDMO #Manufacturing #Asymchem #Pfizer #EuropeExpansion #Pharmaceuticals #Innovation #Sustainability #Biotech 🌱

🔬Parenteral Perspectives: Innovations, Challenges, and Future Horizons in Drug Delivery 🧬 An interesting article outlining how the pharmaceutical industry is shifting towards biotechnology, with biotech product sales expected to triple by 2028, leading to a focus on small-batch and orphan drugs; CDMOs must adapt to the unique requirements of biotech products, including large-molecule biologics and patient-friendly delivery systems for home self-administration. The success of mRNA vaccines is driving expansion into new therapeutic areas beyond oncology and rare diseases, leading to increased demand for treatments for diabetes, cancer, and obesity, as well as for injectables manufacturing capacity due to new modalities like monoclonal antibodies, mRNA, oligonucleotides, and gene therapies. 💉Technological Innovations and Developments so far: ⚗ 🧪 Vetter Pharma - investing €230 million in a new commercial production building in Ravensburg, Germany, as part of a €1.5 billion decade-long plan to enhance aseptic manufacturing capacity, expand lab space, increase filling capacity, and optimize infrastructure. 🔭 August Bioservices, LLC - recently invested in state-of-the-art equipment and new facilities, including seven new filling lines, robotics for aseptic filling, advanced dosing technology, automation for visual inspection, and electronic batch records for efficient traceability. 🌡️Selkirk Pharma - announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility, which features advanced technologies like unidirectional flow, single-use systems, SKAN isolator technology, and Bausch and Strobel VarioSys filling systems, emphasizing flexibility and efficient production. 💊 Grand River Aseptic Manufacturing - expanded its finishing and warehouse center to 200,000 sq. ft., enhancing its capabilities in inspection, packaging, testing, and filling for syringes, cartridges, vials, and advanced drug delivery systems, with a focus on investing in new technology and personnel. The article overall takes a look at how the evolving landscape of parenteral drug delivery presents opportunities and challenges, marked by technological advancements and growing demand for specialized manufacturing processes. It will be interesting to see how strong CDMOs will distinguish themselves through investments in new technology and personnel going forward, positioning themselves for future success by adapting to this industry change and investing in infrastructure and expertise. 👩🔬#CDMO #biotech #biologics #CGT #pharmadevelopment #drugdelivery 👨🔬