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.
Webinar: 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 <1207> “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
Strong Partnership Environment Heralds Success in Pharma Summary: Catalent believes it is essential to share knowledge and experience to improve understanding of drug formulation and delivery challenges and contribute jointly to finding solutions. Will...
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
Accelerate Your Early Drug Development Journey
Learn how to move from the bench to the clinic quickly using advanced technologies
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.
About Us: Catalent Corporate Brochure
We are helping innovators develop, deliver & supply superior products improving people’s lives.
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.
Accelerate More Molecules to Clinic
Identify most suitable drug delivery technology at early stage of drug development.
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.