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.
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…
Summary: This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.
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.
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.
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…
Summary: Pharmaceutical and biotechnology companies approach external development and manufacturing partners for solutions for their product’s specific needs. New products are increasingly…
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…
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.
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…
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…
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…
Summary: Catalent Micron Technologies is a leading international provider of particle size reduction and analytical services. We deliver first-class pharmaceutical contract micronization, milling…
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…
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…
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…
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….
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…
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…
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…
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…
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….
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…
Summary: The Catalent GOLD (Global Organization Leadership Development) Program is a two-year rotational development opportunity…
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…
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…
Summary: Members of our product development eam gain unparalleled experience working on several products using multiple technologies. Hear what it’s like to work…
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…
Lipid formulation and spray-dried dispersions are widely used, and proven technologies to overcome bioavailability challenges for poorly soluble molecules.
Read the latest article published by Pharmaceutical Technology giving an overview of elemental impurities testing and elemental impurities risk assessment process.
This article outlines the preclinical studies to assess and manage developability risks of NMEs for oral drug products
How to create a development strategy that bridges gaps earlier in the process to make the transition smoother.
Lipid-based drug delivery systems provide a reliable solution for poorly soluble molecules
Clarifying the myths surrounding LBDSS which may make drug developers consider it in parallel to other formulation approaches
Developers are looking for ways to predict and overcome potential issues of new molecular entities
Gain more knowledge on dysphagia, which is one of the major factors affecting medication adherence and proper medication administration.
Leveraging knowledge about an API’s physiochemical properties from preformulation and formulation studies increases the chances of early-phase success.
A connected, data-driven approach to managing bioavailability challenges in new chemical entities
Developing specific dosing guidelines and acceptable dosage forms for pediatric patients to optimize therapeutic efficacy and limit and prevent serious adverse side effects.
Developing a tailored package of analysis to ensure compliance with regulatory guidelines.
Innovative dose forms to expand and improve your product line.
This webcast discusses key concepts that should be addressed as a molecule advances through the clinical development phases
The use of Pre-clinical tools to study pharmacokinetics, choose a lead drug candidate and move that product into development.
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 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...
Learn the key considerations for developing a new drug for pediatric patients.
Key insights on guidelines, testing requirements, and analytical approaches for complying with the USP requirements for instrument-based heavy metals testing.
How pre-clinical tools used in the industry to study pharmacokinetics are used to guide the development of new chemical entities (NCEs).
The key considerations for transitioning a molecule from discovery to Phase 1.
Evaluate critical areas in the drug development process to help ensure a successful toxicology study.
A review and quantitative analysis of the molecular properties of approved drugs formulated as lipid systems
The key spray dried dispersion (SDD) development considerations to enhance and sustain in-vivo drug solubility.
A holistic approach to the development and manufacture spray dried dispersions.
The key spray dried dispersion (SDD) development considerations to enhance and sustain in-vivo drug solubility.
Each new drug is unique and deserves a fresh approach to formulation.
Successful spray drying process for clinical and commercial production.
Key considerations for transitioning a molecule from discovery to phase 1 readiness
Unbiased & data-driven approach to select bioavailability enhancement technology.
Quick facts about OptiForm® Solution Suite
Agnostic & data-driven approach for early stages to find optimal formulation technology
Learn how to move from the bench to the clinic quickly using advanced technologies
How pre-formulation techniques can accelerate early phase development to PK and first-in-human studies.
The effect of salt form selection and polymorphic screening on formulation development.
Key development challenges and promising technologies for delivering pediatric formulations.
Crucial factors to transform a pre-clinical compound into a first-in-human candidate.
Latest formulation approaches on enabling oral route for macromolecule drugs for local treatment.
Insight on early development, characterizing solid state forms and first-in-human strategies.
Methods for developing a sound, phase-appropriate formulation for early development.
A parallel formulation feasibility assessment approach to enhance bioavailability.
Discover the latest solutions and advancement in drug delivery technologies.
Create market differentiation and enable products that meet the specific medical needs of individual patients.
Utilize OptiForm Solution Suite to provide options for candidate formulations with extensive supporting data.
A toolkit of superior technologies to overcome all your molecule’s challenges and processing difficulties to get the optimal dosage form.
Enhance bioavailability & efficacy while reducing adverse effects with particle size reduction.
Insights on how to pick the right candidates for clinical development & revamping projects.
Strategies & technologies which can minimize the risks of developing new drugs and more.
We are helping innovators develop, deliver & supply superior products improving people’s lives.
ODT platform ideal for sublingual delivery of proteins, peptides & vaccines.
Explores the benefits of co-micronization with a surfactant and cryogenic micronization.
Understand the logistics of commercial manufacturing using design of experiments (DOE).
Address bioavailability challenges faced in biologic development with a focus on oral delivery.
Mitigate cross-contamination risk and regulatory issues.
Select optimal formulation technology to enhance therapeutic performance & patient experience.
Boost bioavailability, improve ease & route of administration, and increase patient compliance.
Increase the dissolution rates of poorly water-soluble drugs to increase bioavailability.
Increase patient adherence while reducing reformulation time & costs.
Identify most suitable drug delivery technology at early stage of drug development.
Provide the ability to taste mask & coat smaller particle size APIs.
Utilize an all-encompassing approach to enable an effective dosage form faster to market.
Enable the formulation development of a drug molecule in softgels on industrial scale machines.
Increase chances of success in drug development by focusing on API optimization from the start.
Suitable path to accelerate development, avoid risk at early phase & enhance bioavailability.
Select the most suitable formulation technology to enhance the molecule’s bioavailability.
Design a safe, effective & stable dosage form, and ensure patient compliance.
Lipid-based drug-delivery systems to assist in the delivery of poorly soluble drugs.
Perform dosage form selection in the early phases of drug development.
Drug delivery solutions need to become more sophisticated and more effective.
Choose the right technology to develop an efficient Phase I enabling drug product
Solubility screening approaches that can save both time and money.
Scientists now have an arsenal of drug delivery techniques to choose from.
Learn about how softgel technologies can address API and processing challenges.
Learn more about integrating formulation technology in drug development.
Learn about Orphan drug development and other fast track product development pathways.