KLIFO

For 30 years, we have continuously strengthened the core pillars of our business. Today, we provide our clients with extensive expertise, complete flexibility, and strategic and operational support throughout the entire drug development journey:   ✔️ Strategic project management ✔️ Regulatory affairs ✔️ Clinical development ✔️ Clinical trial supply ✔️ Quality assurance (QA) ✔️ Chemistry Manufacturing and Controls (CMC) development ✔️ Non-clinical development ✔️ Pharmacovigilance   Our mission is clear: To help our clients advance their drug development, clinical trials, and manufacturing projects – every step of the way.   #KLIFO30 #DrugDevelopment

Excited to follow the construction of our new facility and being able to work with innovative people to get sustainable solutions incorporated 👍 Looking forward to the final result

🌡️ Leading the way in frozen storage🌡️ At KLIFO, we excel in providing cutting-edge storage solutions for your most critical materials. Whether it is minus 20°C or minus 80°C, our state-of-the-art facilities are designed to ensure the highest level of preservation and security for a wide variety of clinical trial materials, including APIs, drug products, investigational medicinal products and biological samples. 🔬 Minus 20°C: Our spacious storage rooms are ideal for storing sensitive investigational products, APIs and samples that require stable, low-temperature environments. ❄️ Minus 80°C: Currently with 12 GMP-validated ultra-low freezers (and 5 more on the way) we preserve essential materials. These freezers can be configured with customer-specific settings, such as tailored temperature control and 24/7/365 monitoring to meet the unique needs of every project. Our commitment to excellence in cold storage makes us the trusted partner for all your storage needs. #Biotech #ColdStorage #SamplePreservation #KLIFO

What if there was a way to short-cut some of the elements in your drug development process and get a head start… Well, maybe there is 😀 These are Hanne Wulff Nielsen’s, VP Drug Development Counselling at KLIFO, top five recommendations to an early stage biotech company wanting to get a head start: 1️⃣ Know what you’re developing Prioritise developing a target product profile (TPP). It acts as a blueprint, keeping the development focused and goal-oriented, and it demonstrates to investors that you have a well-thought-out strategy for your product’s success. 2️⃣ Focus on robust preclinical data Before diving into clinical trials, ensure your preclinical data is strong. This foundation is critical to secure funding, attract partners, and set your program up for success. 3️⃣ Prioritize scalable processes From day one, design your manufacturing processes with scalability in mind. What works at the bench may not translate seamlessly to larger scales. Early investment in robust, scalable processes will save time and resources later on. 4️⃣ Develop a clear regulatory strategy Take advantage of the opportunity to engage with regulatory bodies, and take your time to plan well for advice meetings. This can save time, reduce costs, and increase the likelihood of approval down the line. 5️⃣ Build a strong team Involve experts who can bring diverse perspectives and are experienced in navigating drug development, from scientific innovation to business acumen. Feel free to reach out to Hanne if you want to discuss how to get started on the drug development process 📱 📧 #Biotech #DrugDevelopment #TPP #RegulatoryAffairs #KLIFO

We are thrilled to welcome Thomas Mueller to KLIFO as our new Senior Director, Business Development DACH 🎉 Thomas brings more than 20 years of experience in the life science industry, having previously worked at several biotech companies and large CROs, where he held different positions in business development and alliance roles. His expertise in clinical development and knowledge of the specific needs of small to mid-sized biopharma organizations will be invaluable in driving our business development efforts in the DACH area, particularly in KLIFOs consulting and CRO businesses. Based in Heidelberg, Thomas visited our Copenhagen headquarters last week as part of his onboarding programme, and we had the pleasure of meeting him and capture this moment on camera 😀 “I am excited to be part of KLIFO and drive the strengthening of our partnerships with the life science industry and expand our presence in Europe”, says Thomas 🌍 Please join us in welcoming Thomas to KLIFO and feel free to connect to learn more about our exciting plans for our drug development, clinical operations and clinical trial supply businesses in the DACH area 🚀 #CRO #ClinicalDevelopment #DACH #KLIFO

KLIFO is celebrating 30 years of excellence in drug development! 🎉 Over the past three decades, we have evolved from a small Clinical Research Organisation in Denmark to a fully integrated drug development consultancy with a presence in four major European life science hubs. Our areas of expertise have expanded to include drug development, clinical operations and clinical trial supply, and we take pride in our tailored and client-focused approach. From candidate selection to market, we support our clients at every step of their drug development projects. As we celebrate 30 years of growth and collaboration, we are energised and focused on the future. The drug development landscape is advancing faster than ever, and we are investing to help our clients harness these opportunities. We are committed to delivering exceptional solutions, ensuring a seamless journey from innovation to impact. To all our clients and team members – thank you for your trust and collaboration over the past three decades. Here's to the next 30 years of accelerating drug development together. 🚀 #KLIFO30 #DrugDevelopment

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