Regional Sites Contact Us ORAL DOSE BIOLOGICS SPECIALTY CLINICAL SUPPLY CONSUMER EXPERT CONTENT LOCATIONS ABOUT US CAREERS Home » Expert Content » Development & Bioavailability EXPERT CONTENT Downloadable expert content covering integrated, tailored solutions to accelerate your path to market. VISIT OUR YOUTUBE CHANNEL BROWSE BY SITES: BIOLOGICS CLINICAL SUPPLY SERVICES CONSUMER HEALTH TOPIC: VIEW ALL DEVELOPMENT & BIOAVAILABILITY DOSE FORM DESIGN ORAL TECHNOLOGIES SOFTGEL TECHNOLOGIES ORAL MANUFACTURING SMALL MOLECULE ANALYTICAL INHALATION SMALL MOLECULE INJECTABLE TYPE: VIEW ALL ARTICLE BROCHURE CASE STUDY EBOOK EXECUTIVE SUMMARY INFOGRAPHIC OFFERING FACT SHEET VIDEO WEBINARS Highly Potent API Drug Product Development and Manufacturing Using Micronization Technology Summary: This webinar will discuss how to classify HPAPIs in early development and share recommendations for safe product handling, from clinical manufacturing to commercialization. Micronization Technology Solutions From Early Phase Development to Commercial Scale Manufacturing Summary: Catalent is a global leader in pharmaceutical air jet milling micronization with more than 30 years’ experience delivering micronization solutions. Concept to Dosing-Challenges in New Orphan Drugs Summary: In this webinar a group of experienced cancer drug developers discusses key strategies in managing an orphan drug program. A Guide to Drug Development of Challenging Molecules Summary: This webinar discusses, key considerations of early drug development, molecule developability assessment, drug bioavailability and discussed the relationship between intracellular and transcellular permeability of beyond the Rule of Five drugs. Effective Scale-Up and Technology Transfer Strategies for Spray Dried Pharma Products Summary: In this webinar, learn from real world case studies about best practices and strategies to mitigate risks and ensure a successful tech transfer from development through to commercial scale spray drying of pharmaceutical products. Pharmaceutical Outsourcing for Oral Development and Manufacturing Summary: This eBook includes an overview of outsourcing trends in the oral solid dose market. Featured articles describe the robust market resulting from the demand for specialized dosage forms such as controlled release, pediatric and geriatric delivery vehicles. Selecting the Most Suitable Dosage Form Technology for the Oral Delivery of Lipid-Based Formulations Summary: Lipid-based drug delivery systems have found widespread acceptance for development of drug products containing developability challenged APIs. Boosting Bioavailability- How Companies are Using Advanced Technologies to Formulate Complex Molecules Summary: This infographic focuses on evolving technologies that help overcome bioavailability challenges enabling the formulation of more complex molecules. Improving Bioavailability Using PBPK Modeling & Parallel Formulation Screening Read this case study to learn how a team of bioavailability experts at Catalent took a target molecule from early stage to Phase 1 in under nine months. High Potency Containment from Early Phase to Commercial Scale Micronization Summary: In this webinar, learn more about enabling micronization of potent and highly potent compounds across the different stages of oral drug development Developing Optimal Formulations Summary: API-sparing development techniques and identification of the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability. Integrated Approach to Spray Drying for Optimized Oral and Vaccine Formulations Summary: In this webinar, an academic expert will discuss optimal design space parameters involved in developing spray dried dispersion of poorly soluble drugs for oral and vaccine delivery. Amorphous and Co-Amorphous Systems for Poorly Soluble Drugs Summary: This webinar provides an overview of co-amorphous research and its recent findings, particularly, the impact of low molecular weight excipient on developability, stability and solubility. Importance of Pediatric Biopharmaceutics in Design and Manufacture of Pediatric Dose Forms Summary: Learn about the current challenges in pediatric drug development programs including predicting oral absorption, and in vitro and in silico methods that can be applied to predict behavior in pediatric populations. What Makes Lipid Excipients So Special? Summary: In this webinar, we explain why a lipid drug development platform can meet the need for speed to clinic and how the innovative lipid excipients and technologies could solve formulation challenges, optimizing bioavailability for early phase molecules, improve patient compliance and bring products faster to market. Getting Your Molecule From Preclinical Dev to Phase I Summary: Three early drug development experts present insights and techniques to help your clients get their molecules from preclinical to Phase 1 studies. A Roadmap for Early Development to Commercial Manufacturing Summary: Phase-appropriate CMC-related activities can facilitate the transition from early development through commercialization. Strategies for Integrated Business, Regulatory, & Scientific Needs of CMC Clients Summary: Drug development requires integrating multi-disciplinary business, regulatory and scientific activities. To successfully support a client’s program, it is imperative to provide advice and services that support all three in the context of a program’s goal. In this exclusive webinar presented by Jim Spavins… Innovative Solutions to Meet the Complex Pharmaceutical Supply Challenges Summary: Integrated approach from development to clinical and benefits of working with a single integrated provider. Pharma Predictions for 2021 Catalent CEO John Chiminski to talks about the year ahead, offering projections for what 2021 holds in store for the biopharma industry. From Candidate to Clinic: Strategies to Accelerate Your Molecule’s Development Path The development of orally administered small molecules is more challenging as an many have poor aqueous solubility and bioavailability. Strategies for De-risking Early-Phase Oral Small Molecule Drug Development Summary: Characterize lead molecules and develop the best pathway to bring them to Phase I studies and beyond. Partnering for Success: Strategies to Mitigate Common Pitfalls in Early Drug Development Summary: Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact how a drug compound… Early Drug Development: Strategy and Solution This webinar focuses on the key considerations for transitioning small molecules from preclinical through clinical development. From Development to Commercialization: Overcoming Scale-Up Issues Summary: Recorded at Manufacturing Chemist Live 2020, this presentation discusses some of the key issues to consider when planning for the scale-up of a small molecule development program. Discover the Latest Funding, Drug Development and Clinical Solutions Strategies Summary: Dramatically shifting the attention of the industry, Covid-19 forced orphan developers to re-examine their go-to-market strategies. Derisking Orphan Drug Programs in 2020 and Beyond Summary: Dramatically shifting the attention of the industry, Covid-19 forced orphan developers to re-examine their go-to-market strategies. Developing Optimal Formulations Using Biorelevant Predictive Tools and Advanced Bioavailability Enhancement Technologies Summary: Low bioavailability can lead to development challenges. Advanced formulation expertise and technologies can increase the chance of success in the clinic. Interview: Fierce Pharma with Jeremie Trochu Summary: Jeremy Trochu, Vice President and General Manager of Pharmaceutical Development Services at Catalent, recently sat down for an interview… Next-Generation Orphan Drug Delivery Summary: Big Pharma used to ignore this segment of the market, but now developing orphan drugs to treat these rare diseases is an industry priority. The Future of Orphan Drugs: Insights on the Current Market, Trends & Strategic Partnerships Driving Innovation Summary: In this report, we will highlight the trends shaping the orphan-drug market, with a particular focus on expedited drug development. Expert insights on navigating development and manufacturing challenges with… Early Phase Solutions Summary: Explore how you can leverage Catalent’s successful track record optimizing thousands of molecules, deep development expertise and broadest set of superior technologies to… Catalent Spray Drying Technology: From Development to Manufacturing Summary: Catalent offers end-to-end spray drying solutions from early-phase development through to clinical supply, and scale-up to commercial finished dose forms. From Candidate to Clinic: Strategies to Accelerate Your Molecule’s Development Path Summary: A fast, efficient development process can deliver the right clinical candidate, best formulation strategy, and optimal dosage form to Phase 1. Setting Up Your Small Molecule for Success: Formulation, PBPK Modeling and Regulatory Strategies in Early Clinical Trials Summary: This webinar focuses on the key considerations for transitioning small molecules from preclinical through clinical development. Reducing Risks In Early Drug Development: From Drug Candidate to Phase 1 Clinical Testing Summary: Achieving success in early development is essential in progressing a drug molecule’s next milestone. Such pressure can often lead to the adoption of… CMC Considerations for Successful Early Drug Development Summary: This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization Summary: In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from early-phase development to late-phase manufacturing. Preparing Your Drug for Clinical Success: Strategies and Considerations Summary: View this webinar to learn about the key considerations for transitioning a molecule from discovery through clinical studies. Based on Exclusive Survey: Bioavailability Enhancement – Industry Insights, Key Challenges & Advanced Development Solutions Summary: In this webinar, experts present the exclusive survey findings and introduce innovative scalable drug delivery technologies proven to address the industry’s growing need for improving solubility and enhancing bioavailability. Spray Drying for Bioavailability Enhancement Summary: The use of spray drying to manufacture amorphous dispersions is continuing to grow due to the number of drug candidates exhibiting poor solubility. Nearly 40% of the new chemical… Strategies for Flexible Manufacturing Summary: Pharmaceutical and biotechnology companies approach external development and manufacturing partners for solutions for their product’s specific needs. New products are increasingly… All Offerings Summary: Catalyst + Talent. Our name combines these ideas. From drug and biologic development to delivery technologies and supply solutions, we are the catalyst for your… A Roadmap for Early Development to Commercial Manufacturing Summary: A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success. Solid Dispersions – A Versatile Formulation Strategy for Poorly Soluble Drugs Summary: The influx of poorly soluble compounds into the drug development pipeline is likely to continue unabated. Solid dispersions provide a formulation technique that is… How to Effectively Work with a Development Partner – From a Consultant Standpoint Summary: Determining a client’s primary goal is critical to guiding them through the development of their asset. Three experienced industry colleagues recently presented on the latest tips… Catalent Micron Technologies Overview Summary: Micron Technologies adds to Catalent’s long history of innovation and leadership in the pharmaceutical industry, with its proven and versatile portfolio of particle size reduction, micronization and milling… Catalent Micron Technologies A Global Leader in Micronization Services Summary: Catalent Micron Technologies is a leading international provider of particle size reduction and analytical services. We deliver first-class pharmaceutical contract micronization, milling… Potent Capabilities for Micronization Summary: Not only are we able to micronize compounds with air jet mills under full containment, but we have also developed containment solutions for several other types of milling equipment… What is Micronization? Summary: Particle size reduction is achieved through the use of fluid energy jet mills. The material is drawn into a confined, circular chamber by way of pressurized nitrogen gas or compressed… Orphan Development Capabilities | Why Catalent? Summary: Accelerated regulatory pathways of fast track and breakthrough designations can often shave years off the approval process. Accelerating the development and approval of many drugs is often in everyone’s interest… Catalent in 30 Seconds Summary: With over 80 years serving the industry, Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products…. Optimal Drug Delivery Technologies. Better Treatments. Summary: We are your catalyst for creating better treatments. Our deep expertise in drug development, delivery and supply can help improve the bioavailability of your compound, enhance therapeutic profiles… Catalent Corporate Overview Summary: Catalent is the global leader in development, delivery, and supply for pharmaceuticals, biologics, and consumer health products. Integrated analytical and clinical supply services support to… Preclinical Techniques for Successful Drug Development Summary: In this video series, P.Y. Chen, Ph.D., of Catalent Pharma Solutions offers insights for accelerating early drug development and mitigating risk. Expert insight… Mitigating Risks During Preclinical Development Summary: In this video series, P.Y. Chen, Ph.D., of Catalent Pharma Solutions offers insights for accelerating early drug development and mitigating risk. An expert’s view on various tools available to… Ensuring Client’s Success in Early Drug Development Summary: In this video series, P.Y. Chen, Ph.D., of Catalent Pharma Solutions offers insights for accelerating early drug development and mitigating risk. Learn how Catalent can…. Join Catalent in Bringing Better Treatments to Patients Worldwide Summary: At Catalent, you will have numerous opportunities to take personal initiative, thrive in a dynamic environment, and make an impact. Allow our employees to tell you about life at Catalent and… Meet Aileen B. – GOLD Graduate Summary: The Catalent GOLD (Global Organization Leadership Development) Program is a two-year rotational development opportunity… Catalent Cares – Erica’s Story Summary: Catalent supports employees who are passianate about a cause or helping the community. Hear how Catalent supported Erica and her team to raise money… Career Development at Catalent Summary: Catalent offers employees numerous opportunities for development and career progression. Hear more about what our team has to say about how Catalent supports their… Product Development Careers at Catalent Summary: Members of our product development eam gain unparalleled experience working on several products using multiple technologies. Hear what it’s like to work… Evolution of Container Closure Integrity Testing Summary: The USP general chapter “Package Integrity Evaluation – Sterile Product” deeply changes the way it considers the Container Closure Integrity Testing (CCIT) within the pharmaceutical… Formulation Development for Scalability Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules. Commonly Asked Questions About Elemental Impurities Read the latest article published by Pharmaceutical Technology giving an overview of elemental impurities testing and elemental impurities risk assessment process. De-Risking and Accelerating Oral Drug Development This article outlines the preclinical studies to assess and manage developability risks of NMEs for oral drug products Streamline Early Drug Development How to create a development strategy that bridges gaps earlier in the process to make the transition smoother. Using Lipid Based Delivery For Early Phase Development Lipid-based drug delivery systems provide a reliable solution for poorly soluble molecules The Truths and Myths of LBDDS Clarifying the myths surrounding LBDSS which may make drug developers consider it in parallel to other formulation approaches Data-Driven Risk Assessment Developers are looking for ways to predict and overcome potential issues of new molecular entities Dysphagia Dose Design Gain more knowledge on dysphagia, which is one of the major factors affecting medication adherence and proper medication administration. PBPK Modeling and Other Strategies for Early Phase Success Leveraging knowledge about an API’s physiochemical properties from preformulation and formulation studies increases the chances of early-phase success. Next Generation of Small Molecule Oral Drugs A connected, data-driven approach to managing bioavailability challenges in new chemical entities Pediatric Patient Considerations During Dose Development Developing specific dosing guidelines and acceptable dosage forms for pediatric patients to optimize therapeutic efficacy and limit and prevent serious adverse side effects. The Importance of Assessing Elemental Impurities Developing a tailored package of analysis to ensure compliance with regulatory guidelines. Expanding Your OTC Brand Innovative dose forms to expand and improve your product line. Dose Design: Bridging Early- And Late-Phase Development This webcast discusses key concepts that should be addressed as a molecule advances through the clinical development phases Best Practices for Identifying Development Candidates The use of Pre-clinical tools to study pharmacokinetics, choose a lead drug candidate and move that product into development. Phase Appropriate Stability Studies Regulatory requirements and technical challenges for stability studies vary depending on the phase of the program, the intended market and the product type. Strong Partnership Environment Heralds Success in Pharma Will Downie, Senior Vice President, Global Sales and Marketing at Catalent, explains how his company makes a success of this strategy Pediatric Patient Considerations During Dose Development Learn the key considerations for developing a new drug for pediatric patients. Elemental Impurities in the Pharmaceutical Industry Key insights on guidelines, testing requirements, and analytical approaches for complying with the USP requirements for instrument-based heavy metals testing. Dose Selection Using Preclinical PK Modeling How pre-clinical tools used in the industry to study pharmacokinetics are used to guide the development of new chemical entities (NCEs). Delivering the Right Drug Candidate in the Early Phase The key considerations for transitioning a molecule from discovery to Phase 1. Design & Formulation for GLP Toxicology Studies Evaluate critical areas in the drug development process to help ensure a successful toxicology study. Review and Analysis of FDA Approved Drugs Using Lipids A review and quantitative analysis of the molecular properties of approved drugs formulated as lipid systems Bioavailability Enhancement Through Spray Dried Dispersions The key spray dried dispersion (SDD) development considerations to enhance and sustain in-vivo drug solubility. Catalent Spray Drying Technology A holistic approach to the development and manufacture spray dried dispersions. Bioavailability Enhancement through Spray Dried Dispersions The key spray dried dispersion (SDD) development considerations to enhance and sustain in-vivo drug solubility. Let the Molecule Decide Each new drug is unique and deserves a fresh approach to formulation. Tech Talks with Catalent – Spray Drying Technology Successful spray drying process for clinical and commercial production. Smart Drug Development & Design from Candidate to Phase I Key considerations for transitioning a molecule from discovery to phase 1 readiness Data-Driven Approach to Overcome Bioavailability Challenges Unbiased & data-driven approach to select bioavailability enhancement technology. Optiform® Solution Suite Quick facts about OptiForm® Solution Suite Developing Oral Dosage Forms Agnostic & data-driven approach for early stages to find optimal formulation technology Expedite Early Drug Development How pre-formulation techniques can accelerate early phase development to PK and first-in-human studies. Importance of Defining & Characterizing Solid State Forms The effect of salt form selection and polymorphic screening on formulation development. Pediatric Drug Delivery Challenges and Solutions Key development challenges and promising technologies for delivering pediatric formulations. Preclinical & First-in-Human Development Strategies Crucial factors to transform a pre-clinical compound into a first-in-human candidate. Oral Delivery of Macromolecule Drugs for Localized Treatment Latest formulation approaches on enabling oral route for macromolecule drugs for local treatment. Early-Phase Pharmaceutical Development Strategies Insight on early development, characterizing solid state forms and first-in-human strategies. Preclinical & First-in-Man Drug Development Strategies Methods for developing a sound, phase-appropriate formulation for early development. Improve Your Phase I Success Rate A parallel formulation feasibility assessment approach to enhance bioavailability. AAPS 2016 Presentations Discover the latest solutions and advancement in drug delivery technologies. Particle Size Reduction to Improve Drug Performance Create market differentiation and enable products that meet the specific medical needs of individual patients. Improved Bioavailability of Trio Medicines TML-2 Utilize OptiForm Solution Suite to provide options for candidate formulations with extensive supporting data. Brochure: Development Solutions A toolkit of superior technologies to overcome all your molecule’s challenges and processing difficulties to get the optimal dosage form. Thinking Small Enhance bioavailability & efficacy while reducing adverse effects with particle size reduction. New Approaches to De-risking Early Drug Development Insights on how to pick the right candidates for clinical development & revamping projects. Optimize Dosage Form for Patient-Centric Drug-Development Strategies & technologies which can minimize the risks of developing new drugs and more. The Versatile Orodispersable Tablet (ODT) Technology ODT platform ideal for sublingual delivery of proteins, peptides & vaccines. Versatility of Micronization for Bioavailability Enhancement Explores the benefits of co-micronization with a surfactant and cryogenic micronization. Critical Process Parameters of an API via Micronization Understand the logistics of commercial manufacturing using design of experiments (DOE). The Medicine Maker – Bioavailability by Design Address bioavailability challenges faced in biologic development with a focus on oral delivery. Holistic Approach To High Potency API Operations Mitigate cross-contamination risk and regulatory issues. Novel Technologies To Deliver Oral Oncology Therapies Select optimal formulation technology to enhance therapeutic performance & patient experience. Catalent Innovations, Trends and New Technologies Boost bioavailability, improve ease & route of administration, and increase patient compliance. Accelerated Bioavailability for Early Phase Molecules Increase the dissolution rates of poorly water-soluble drugs to increase bioavailability. Addressing Early Phase Development Challenges Increase patient adherence while reducing reformulation time & costs. Novel Coating Process for Taste Masking APIs Provide the ability to taste mask & coat smaller particle size APIs. A Structured Approach to Enhancing Bioavailability Utilize an all-encompassing approach to enable an effective dosage form faster to market. Optimizing Small Batch Size To Solve Formulation Challenges Enable the formulation development of a drug molecule in softgels on industrial scale machines. The Medicine Maker – Finding Optimal Form Increase chances of success in drug development by focusing on API optimization from the start. Bioavailability Enhancement for Early Phase Molecules Suitable path to accelerate development, avoid risk at early phase & enhance bioavailability. Solution Suite Accelerates Bioavailability Enhancement Select the most suitable formulation technology to enhance the molecule’s bioavailability. Bioavailability Toolkit to Fast Track Development Design a safe, effective & stable dosage form, and ensure patient compliance. Overcoming Poor Solubility in Formulation Development Lipid-based drug-delivery systems to assist in the delivery of poorly soluble drugs. Overcome Early Phase Development Challenges Perform dosage form selection in the early phases of drug development. New Technologies for Complex Oral Formulation Drug delivery solutions need to become more sophisticated and more effective. Early Technology Selection for Optimized Drug Development Choose the right technology to develop an efficient Phase I enabling drug product Formulation Development with Minimal Amount of API Solubility screening approaches that can save both time and money. The Bioavailability Toolbox Scientists now have an arsenal of drug delivery techniques to choose from. Optimize Your Oral Drug Development Pathway Learn about how softgel technologies can address API and processing challenges. New Formulation and Delivery Technology is Unlocking Profit Learn more about integrating formulation technology in drug development. Strategies for Orphan, Breakthrough and Fast Track Programs Learn about Orphan drug development and other fast track product development pathways. Expert Content Subscribe Investors Careers Contact Us Site Map Follow Us. Share Us. By using this website you understand and accept that Catalent tracks your website activities to be able to offer you a more tailored response or information to meet your requirements, and that your personal data will be held in accordance with our Privacy Policy | Privacy Shield Statement | Cookies Settings. 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