Webinar-Preparing for Phase 1: Strategies for Success in Advancing your Drug to First-in-Human Trials
Summary: During this webinar, biopharma R&D professionals will review strategies for moving successfully and efficiently from preclinical studies to first-in-human trials. They will call upon their own experiences to provide advice that will help others in the industry navigate this crucial transition.
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.