Knowledge Center

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Achieving the right particle size for respiratory drug delivery is crucial, and jet milling is a key technique. But how do you choose the right API solid form (salt, cocrystal, or solvate) for successful micronization and high yields? This webinar o...

White paper

15 min read

Exploring the Need for Dose-Flexible Manufacturing

Bringing a new drug to market is a complex journey, often involving various dosage forms throughout clinical development. From initial discovery to final product, the needs can shift dramatically. For example, pediatric and oncology medicines often requir...

Webinar (on-demand)

Linking Rational Design and Material-Sparing Strategies for Enabled Intermediates and Their Drug Products

The rapid development of enabled forms and formulations is crucial for tackling the challenges posed by poorly soluble molecules. In this webinar, we delve into the importance of identifying unique risks to oral bioavailability and explore effective solut...

Webinar (on-demand)

Flexible-Dose Development Strategies for Today's Clinical Landscape

This on-demand webinar explores the importance of dose-flexible manufacturing strategies in modern drug development. With a growing emphasis on early clinical studies, especially in pediatric and oncology treatments, flexible dosing is becoming crucial. H...

Webinar (on-demand)

How to Bring (Any) mRNA to Life - Simplifying Nucleic Acid Encapsulation

Current delivery systems for the encapsulation of Nucleic Acids have strengths and weaknesses. In this on-demand webinar, new technologies for the encapsulation of Nucleic Acids such as FDmiX that can potentially overcome the limitations of currently avai...

Webinar (on-demand)

PBPK Modeling for Identifying and Mitigating Absorption Risks in Early Drug Development

When coupled with in vitro measurements, PBPK modeling is effective in early development for 1) identifying absorption risks, 2) assessing the potential for solubility enhancing formulations such as salts, cocrystals, or amorphous solid dispersions to mit...

Presentation (slides)

8 min read

Optimizing GMP Manufacturing of Lipid Nanoparticles

Lonza is now offering next-generation encapsulation of nucleic acids with FDmiX. In this presentation you will find data demonstrating that the use of this new mixing device results in high manufacturability, stability and homogeneity of nucleic acid Lipi...

Article

3 min read

Simplify the Encapsulation Process of Nucleic Acid Payloads with FDmiX Technology

Enable a reliable, swift scale-up to cGMP manufacturing for mRNA encapsulation with the high-end FdmiX technology. Discover how to master challenges, streamline production and allow for faster, more predictable development of nucleic acid delivery systems...

Technical/Service brief

5 min read

Bioavailability Enhancement Technologies

The increasing fraction of low-solubility compounds in drug discovery has necessitated routine use of enabling technologies to improve oral drug absorption and bioavailability. However, choice of the best enabling technology can be challenging. Lonza empl...

Technical/Service brief

3 min read

Micro-Dosing and Powder-in-Capsule Evaluations

Lonza's leadership in powder-in-capsule (PIC) development using our Xcelodose™; precision powder micro-dosing systems technology spans more than 200 active pharmaceutical ingredients (APIs) and more than 600 batches. This micro-dosing platform and extens...

Technical/Service brief

5 min read

Hot-Melt Extrusion Technology

Hot melt extrusion (HME) is a leading approach to producing amorphous solid dispersions to increase solubility and bioavailability of promising drug compounds. HME technology offers numerous advantages, including well-defined process understanding, small ...

Technical/Service brief

PBPK Predictive Modeling Services

Physiologically based pharmacokinetic (PBPK) modeling simulates dynamic physiological factors impacting oral performance, and when coupled with in vitro testing and experience in addressing key formulation challenges such as bioavailability, has proven ef...

Webinar (on-demand)

CMC and CDMO: The Importance of Choosing the Right Partner

Small pharma companies are driving pipeline innovation and are increasingly taking more complex small molecules further down the development pipeline, if not all the way to market. The growth in expedited regulatory programs has added a need for greater s...

Webinar (on-demand)

Multiparticulate Approaches to the Design, Development, and Commercialization of Flexible Dosage Forms

Multiparticulate technology is seeing increasing use in the pharmaceutical industry to enable modified release, high dose, and age-appropriate dosage forms. Familiarity with key concepts in technology selection, development, scale up and commercialization...

e-book

Formulation of Dry Powder Inhaler

Spray drying, a particle engineering technique used to convert a liquid feed into a dry powder in a single, continuous step, is one of the most promising manufacturing techniques currently utilized in the pharmaceutical industry. The control that spr...

Article

How CDMOs Can Help Small Biotechs Meet Timeline Goals for Their Product Pipeline

The right integrated CDMO can help a small biotech company move a project into and through the clinic and onto the market with ease. It can be challenging for small biotech companies to find the best possible drug development process to bring their drugs ...

Presentation (on-demand)

in vitro -in silico Tools for Performance Testing of Amorphous Solid Dispersions

Development of robust oral drug products requires biopredictive in vitro dissolution methods to evaluate how drug formulation and GI physiology impact bioperformance. Knowledge of the in vivo problem statement and rate-determining step to absorption can a...

Presentation (on-demand)

Dramatic Reduction of Solvent Usage in Pharmaceutical Spray Drying

Spray drying is a commonly used process for producing amorphous solid dispersions (ASDs) of drugs that are poorly water soluble. This requires the use of large volumes of organic solvents to dissolve the drug and polymer prior to processing. Drug molecule...

Webinar (on-demand)

Improved Delivery of Poorly Soluble Compounds Using Capsule Formulations

In this webinar, two experts from Lonza will look at issues around drug solubility, and how bioavailability can be improved. Compounds that are poorly soluble in water are still prevalent in the drug development pipeline, and technologies such as amorphou...

Article

5 min read

A Q&A With The Experts: New Technologies To Improve Solubility Of Brick Dust Compounds

This Q&A session explores three enabling technologies designed to improve drug solubility in organic solvents for spray drying.

Presentation (slides)

Streamlined selection of in vivo predictive dissolution media for in vitro testing of poorly water soluble drugs

Oral drug product administration is the most common delivery method in the pharmaceutical industry. Successful oral delivery requires dissolution of solid dosage forms in gastrointestinal (GI) fluids and permeation across the GI membrane. Therefore, effic...

Presentation (on-demand)

Rapid Development of Amorphous Solid Dispersions for Improved Bioavailability

A growing number of drugs in the development pipeline are poorly soluble in gastrointestinal fluids, and can severely limit oral bioavailability. This talk describes how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro...

Webinar (on-demand)

Solid Form Screening And Rapid Formulation Selection

In this on-demand webinar, case studies will highlight how a combination of experience, targeted testing, and basic scientific principles can quickly lead to the selection of progressible, commercially viable, formulations in early drug development. Click...

White paper

Selecting In-Vitro Dissolution Methodologies For Amorphous Solid Dispersions

Read an article by Life Science Connect about how achieving good in vivo performance is a key attribute for ensuring safety and efficacy of oral solid dosage (OSD) forms intended for systemic delivery. Yet, new drug targets and mechanisms of action contin...

Webinar (on-demand)

Streamlined Selection of in vivo Predictive Dissolution Media

Oral administration is the most common delivery method for medicines. If a patient is to get full benefit from an oral medicine, the solid dosage form must first dissolve in their gastrointestinal (GI) fluids, and then permeate across the GI membrane. The...

Peer-reviewed publication

in vitro -in silico Tools for Streamlined Development of Acalabrutinib Amorphous Solid Dispersion Tablets

Amorphous solid dispersion (ASD) dosage forms can improve the oral bioavailability of poorly water-soluble drugs, enabling the commercialization of new chemical entities and improving the efficacy and patient compliance of existing drugs. However, the dev...

Webinar (on-demand)

Dry Powder Inhalation Delivery of Monoclonal Antibodies

Monoclonal antibodies (mAbs) are powerful therapeutics that address unmet treatment needs in a wide range of serious diseases. Local delivery of mAbs used in the treatment of lung indications via the inhalation route may help reduce dose, limit systemic e...

Presentation (on-demand)

Powder in Capsule: A Way to Accelerate Drug Product Development by Technologies

The Powder in Capsule (PIC) approach by means of micro-dosing provides an alternative pathway for drug development. Micro-dosing provides a quick way to evaluate the drug substance performance and remain cost-conscious to investments in the development of...