KLIFO

A POTENCY ASSAY, also called a biological assay or bioassay, must be INCLUDED IN THE SPECIFICATION FOR BIOLOGICAL PRODUCTS according to the ICH Q6B guideline❗ Potency assays often involve complex in vivo or ex vivo systems such as animals, isolated tissues or cells, and demand highly-specialised expertise throughout development. Our colleague Susanne Boysen, Senior CMC Expert, has years of experience with potency assays, and we’ve asked her to share a few recommendations when working with the development of potency assays: 1️⃣ "The potency assay MUST MEASURE A BIOLOGICAL ACTIVITY representing the mechanism of action (MOA) of the product and, if possible, should be related to the clinical response. 2️⃣ It is CRITICAL TO SELECT AND DEVELOP A SUITABLE POTENCY ASSAY. Assay variation and out-of-specification results can be minimized in the assay design and layout. Some guidance for this can be found in ICH Q14. 3️⃣ A CELL-BASED ASSAY is often used as potency assay, but this is not a requirement, depending on the products MOA and stage of development. SURROGATE ASSAY such as binding assay can be acceptable throughout development and for marketing application. For some biological products, surrogate assay is acceptable early in clinical development while a cell-based assay is required later in development. 4️⃣ Potency assays must be VALIDATED IN A PHASE-APPROPRIATE MANNER according to ICH Q2. In the early phases, regulatory acceptable validation parameter depends on the nature of the drug and can be justified, but often parameters like specificity, accuracy, precision, linearity and working range are included in the phase I/II validation. The full validation package for a potency assay is expected for the marketing application, at the latest. 5️⃣ Acceptable ‘ACCEPTANCES CRITERIA LIMITS’ in the specification for a potency assay depends on the nature of the assay and on the stage of development. The limits are expected to be tightened during the drug development phases and will be data driven. However, wide acceptances limits are often not accepted by the regulatory authorities and an effort to optimize or change the assay to tighten the limits might be required.   6️⃣ I often recommend to DISCUSS THE POTENCY ASSAY STRATEGY WITH REGULATORY AUTHORITIES during the clinical development programme to ensure alignment as early as possible, thereby avoiding submission or clinical trial delays. This could be a part of the specification strategy discussion.” Feel free to reach out to Susanne, if you want to discuss potency assays and how to avoid CMC documentation pitfalls📱 💻 😀 #DrugDevelopment #CMC #PotencyAssays #BioAssays #KLIFO

We will bring a special guest…😊 We are looking forward to next week, when we will be attending the OCT & CTS Nordics 2024 conference in Copenhagen. The KLIFO team will be represented by Christina Vinum, VP Clinical Trial Supply Solutions, Klas Rådberg, Senior Strategic Advisor and Simon Bendix Hørup Nord, Commercial Director. BUT... we will also bring a special guest to the conference: Our new colleague Jesper Prior Larsen, Business Development Director for the Nordics, will have his first official day here at KLIFO on 1 October 2024, and he is ready to hit the ground running at this year’s OCT & CTS Conference🏃 😀 Find us at booth #22 – we look forward to connecting and discussing how KLIFO can be your strategic and operational partner in Drug Development, Clinical Operations and Clinical Trial Supply. And please join us in giving Jesper a warm welcome💐

How do you release an Investigational Medicinal Product (IMP) to a clinical trial? We’ve asked Erik Zobel, Senior Director Quality Assurance QP & RP to provide a few guidelines… #DrugDevelopment #QP #IMP #KLIFO

How can we be your strategic and operational partner in drug development, clinical operations or clinical trial supply ❓ Connect with us at the NLS Days in Malmö, Sweden on 18 - 19 September 2024 – we’re ready to discuss how our tailor-made solutions can align with your unique drug development requirements 📅 💬 👉 Meet the KLIFO team – Klas Rådberg, Senior Strategic Advisor and Christina Vinum, VP Clinical Trial Supply Solutions – at Booth B1.5 Partnering at the NLS Days is powered by life sciences partnering system PartneringONE™.💻 Let’s connect for a one-on-one meeting – or you can just stop by our booth for a chat 😀 We look forward to seeing you in Malmö. #DrugDevelopment #LifeSciences #NLSDays #KLIFO

Today, we’re making history – well, KLIFO history at least 😀 Why? Because today, we welcome our first ever Graduates - Sofie Schultz Pedersen, Katrine Grønquist and August Lau Søberg – who have joined our “Graduate Programme: Clinical Supply Manager” to kick-start their careers in life sciences ✨ The KLIFO Graduate Programme is an intensive nine-month programme divided in three development phases: LEARN, TRAIN and INTERN. By the end of the programme, Sofie, Katrine and August will have: ✔built knowledge in project management ✔ learned what it takes to lead and manage clinical trial supply and logistics activities ✔ worked on real-life projects supported by experts in the field ✔ gained first-hand exposure to industry trends ✔ the skills to launch a life sciences career as a Clinical Supply Manager🏆 And to train, support and mentor them along the way, they will have Berit Schultz. Berit is Senior Clinical Supply Manager in our Clinical Trial Supply Solutions department, and she is also one of the originators of KLIFO’s first ever Graduate Programme. What a dream team 😀 Please join us in giving a warm welcome to Sofie, Katrine and August 💐 Feel free to reach out to Berit, if you want to know more about our Graduate Programme.

Swing by KLIFO’s stand for a chat with our CEO Rasmus Nelund and our Commercial Director Simon Bendix Hørup Nord at the annual "The Future of Swedish & Danish Life Science" conference on 29 August 2024 in Medicon Village in Lund 📅 👉 Rasmus and Simon will be happy to showcase our services and discuss how KLIFO’s scientific, strategic and operational capabilities can support your drug development project. If you would like to schedule a meeting in advance, please do reach out here or via the event’s online partnering platform, “Meeting Mojo” 💻 📱 We look forward to seeing you 😀 #DrugDevelopment #lifesciences #MediconVillage #KLIFO

On our way to celebrate the official Grand Opening of Fuglebakken, Symbion Community’s latest offspring and the location of one of KLIFO's satellite offices here in Copenhagen🎉😀 We’ve been off to a flying start at our new premises, and we have so enjoyed the entrepreneurial spirit and the process of getting to know all our new office neighbors during this “initial moving in phase” 👷⚒😄 This afternoon, however, Fuglebakken is looking spick and span and ready for the Grand Opening with official speeches, a guided tour, bubbly and ample opportunity to network across professions and companies. What a way to spend a Thursday afternoon 🥂🎈 A big congratulations to Symbion and their team here at Fuglebakken – here’s to many more celebrations and continued success 🌟🌼 #GrandOpening #DrugDevelopment #Fuglebakken #KLIFO

Many of our clients face this challenge: How do we establish clinical phase appropriate drug substance and drug product specifications? We always begin the dialogue by discussing the following six concepts and activities: 1.  The PURPOSE of having appropriate drug substance and drug product specifications is to minimise or at best eliminate the risk to the patient by ensuring safety, efficacy and a consistently high quality of the pharmaceutical product. 2.  Specifications DEFINE general and product specific critical quality attributes as well as the acceptance criteria and the analytical technologies applied to secure reliable results. 3.  At all stages of development, the specifications should be BASED ON relevant experience from earlier development phases and reflect the current stage of development. 4.  The justification of the specification should REFLECT the intended route of administration, dosage form, non-clinical exposure levels, clinical doses, manufacturing process, sources of starting materials, process aids and excipients, the capability of the manufacturing process to reduce the level of impurities, as well as stability of both active and inactive components. 5.  We often recommend to DISCUSS the specification strategy with regulatory authorities during the clinical development programme to ensure alignment as early as possible thereby avoiding submission or clinical trial delays. 6.  It is imperative to STUDY relevant guidance literature, e.g. ICH guidelines, regional authority guidelines, and compendial standards. It is important to notice that some guidelines primarily cover expectations to specifications for documentation of commercial products. Feel free to reach out to Jes Kristian Jacobsen, Senior CMC Expert here at KLIFO to discuss how to establish clinical phase appropriate drug substance and drug product specifications to avoid CMC documentation pitfalls. #DrugDevelopment #CMC #KLIFO

Cancer immunotherapy (CIT) continues to be an area of intense research and development based on increased knowledge and new innovative methodologies. In CIT first-in-human trials, critical success factors can be divided into four categories: ✔ Conduct CIT is still a relatively new therapeutic approach. Generating high quality clinical data requires careful selection of knowledgeable and experienced CRO partners and motivated investigators. ✔ Scientific advice Early engagement of regulatory authorities can reduce risk of resistance and setbacks later on. ✔ Trial design Use of advanced trial designs (e.g. basket trials and adaptive design) can greatly increase development flexibility and reduce time to approval and needs to be supported by relevant pre-clinical data. ✔ Investigational Medicinal Product (IMP) It is essential to plan for timely development, GMP manufacturing, release and distribution of the often sensitive IMP handling. At KLIFO, we are actively involved in developing cancer immunotherapy agents for several international biotech companies. Our knowhow and knowledge within this field is broad and constantly expanding. From our extensive network of highly qualified specialists, we can provide guidance on how to bring your therapeutic agent from the lab to the patient. Feel free to reach out to our colleagues in KLIFO Drug Development Consulting to discuss how we can support your CIT project. #KLIFO #DrugDevelopment #StrategicAdvice #OperationalSupport #CIT

On 24 July 2024, Simone Ahrens-Mende Director of Data Management and Biostatistics at KLIFO will be hosting the webinar "Ensuring Compliance and Data Integrity in eClinical Systems: Navigating EU Regulatory Frameworks and Best Practices." 👥 The webinar is part of ACDM’s series of “Hot Topics” in Clinical Data Management. It is a great opportunity to stay at the forefront of clinical research and data management, and to gain valuable insights and practical tips from Simone’s extensive 23-year career in clinical research and eClinical systems. 🎯 The webinar will focus on: - Navigating EU regulatory frameworks - Best practices and strategies - Comprehensive compliance approach - Real-world insights 🔗 ACDM members and non-members keen on mastering these critical aspects of Data Management and Biostatistics can join the learning session. Participation requires registration at: ACDM Webinar Registration - https://lnkd.in/epqBzHZc. #DataManagement #eClinicalSystems #DataIntegrity #ACDM #KLIFO