From Basics To Best Practices: Exploring Bioassays And Binding Assays
Summary: Biologics analytical testing is rapidly evolving as new testing protocols become available and companies seek to expedite current methodologies. Learn about the latest cell-based bioassays…
Strategies For Speeding Time To Clinic For Biotherapeutics
Summary: As the need for accelerated biopharmaceutical development around the world continues to grow, companies are facing complex challenges that need to be overcome to remain competitive for increasing process productivity…
Biologics Development
Summary: Catalent Biologics provides comprehensive services to meet complex biologic development needs. Click to see our global locations and services.
Beating the Clock – Case Studies in Expediting Biologic Development
Summary: Biologic drug development is complex, requiring broad capabilities and expertise to ensure the highest likelihood of regulatory approval and commercial success. The journey from cell line development…
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 animal 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.