Knowledge Center

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SimpliFIH® Solutions: Integrated Approach To First-in-Human for Bioavailability-Challenged Molecules

Oral administration of small molecules has become increasingly difficult because most new candidates demonstrate poor aqueous solubility. The bioavailability hurdle is made more challenging with the accelerated timelines, limited drug substance availabili...

Poster

Using in vitro and in silico Tools to Predict in vivo Bioperformance of a Novel Amorphous Solid Dispersion Dosage Form Architecture

For amorphous solid dispersions (ASDs) made with active compounds that tend to recrystallize in solution, standard in vitro testing strategies often overpredict precipitation in the intestinal tract. This poster describes use of a carefully designed biore...

Presentation (slides)

APIs and ADCs – A Journey Through High Potency

Development of highly potent active pharmaceutical ingredients (HPAPIs) can be quite challenging. Crossing the boundary from small molecules to biologics into antibody-drug conjugate (ADC) territory adds levels of complexity. This presentation provides a...

Presentation (slides)

Formulation Selection and in vitro Screening for Oral Bioavailability Enhancement

This presentation focuses on the rationale for selecting technologies that enable progression of poorly soluble compounds, based on compound's physical properties (e.g., melt and glass-transition temperatures, Log P) and product specifications (e.g. dose,...

Article

Becoming a Champion Go Player

Although antibodies, at the time of writing, still dominate the clinic, there is a definite shift in the drug development pipeline towards more "complex", next-generation molecules. The array of new formats for the NGB sector is bewildering. Any expressio...

Article

Becoming a Champion Go Player

Webinar (on-demand)

APIs and ADCs – A Journey Through High Potency

White paper

Answering Today's Pharma Dilemma of Build or Buy

The need to increase speed and flexibility in drug development and manufacturing has led to new strategies to improve the development and clinical trial process. It has also led to technological innovations, such as those driving the implementation of con...

White paper

Because Scale Matters: A Flexible Approach To Demand Uncertainty

A number of developments are translating into a growing demand for mid-scale manufacturing among pharmaceutical and biotech firms. Fragmenting of patient populations through either targeted therapies, more personalized treatment protocols or competing pro...

Webinar (on-demand)

The Successful Evolution of Biotherapies from Discovery to Development

A large portion of biologics fail during development due to issues with efficacy, safety, or manufacturability. Evaluating potential liabilities as early as possible during the molecule design and lead selection phases can greatly increase the chances of ...

White paper

JAPANESE – Requirements for fully-integrated service-offerings in a HPAPI and cytotoxic environment

Drug-product development for highly potent APIs (HPAPIs) is challenging. This webinar provides best practices for developing and manufacturing highly potent compounds, infrastructure requirements that can facilitate development, and accelerated timelines ...

e-book

10 min read

eBook Chapter from "Pharmaceutical Biotechnology" – Protein Stability and Characterization

Throughout the development process of protein therapeutics a broad array of analytical techniques is applied on a routine basis to measure various molecular attributes. These measurements are carried out in the context of the quality control system of the...

Poster

An Engineered Platform for High-Loaded Dosage Forms of Amorphous Solid Dispersions

This poster outlines a novel engineered platform for the formulation of high-active-loading oral solid dosage forms containing amorphous solid dispersions (ASDs) of a rapidly crystallizing drug with a low glass-transition temperature (Tg). An engineered d...

Peer-reviewed publication

Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator and Precipitation Pathways Analyses

This paper describes work aimed to explain the differences in oral performance in fasted humans for three different dexketoprofen trometamol (DKT) salt formulations, using a combination of in vitro techniques and pharmacokinetic analysis. This work demons...

Article

Manufacturing New Modalities

Biocentury article on regulation for manufacturing new modalities.

Video

ARM Manufacturing Panel

Alberto chairing manufacturing panel at March 2019 ARM investor day in NYC featuring Andy Holt, bbb, Voyager, Pfizer and GSK.

Peer-reviewed publication

Mechanistic Study of Belinostat Oral Absorption From Spray-Dried Dispersions

Spray-dried dispersions(SDDs) are an important technology for enhancing the bioavailability of drug compounds with poor aqueous solubility. To design an effective oral SDD formulation, the key rate-determining step(s) for oral drug absorption must be unde...

Video

Opening plenary address at the Phacilitate Leaders Summit from Alberto Santagostino

Alberto Santagostino, Head of the Cell & Gene Technologies Business Unit at Lonza, gave the opening presentation titled 'Keeping up with the pace of technology in an evolving field of innovation' at the 2019 annual Phacilitate Leaders' Summit in Miami...

Presentation (slides)

Controlling the Particle Morphology of Spray-Dried Eudragit L100 Polymer

Eudragit L100--poly(methacrylic acid-co-methyl methacrylate) or PMMAMA is a useful matrix polymer in the preparation of spray-dried dispersions (SDDs), imparting excellent physical stability, limited gastric release, and fast dissolution rate at intestina...

Peer-reviewed publication

Full Spotlight on Development and Manufacturing of Next-Generation Viral Vectors

Sponsored spotlight from Bioinsights, sponsored by Lonza and featuring articles and interviews.

Video

Latest advances in automated platforms

1h webinar focused on autologous platforms and the cocoon device, followed by a Q&A.

Peer-reviewed publication

Report of the International Conference on Manufacturing

Elsevier peer-reviewed paper and international conference report on manufacturing and testing of pluripotent stem cells.

Report

Phacilitate Special Interest Group on Automation

40 page report co-authored from multiple key players in the industry on automation in cell and gene therapy.

Video

Making it happen: the road to commercial-scale

1h webinar focused on CT technology platforms including autologous, 3D bioreactors, iPSCs.

Presentation (slides)

Multiparticulate Technologies for Pediatric Products and Formulation Considerations and Strategies for Pediatrics

This presentation examines the advantages of using multiparticulates as a pediatric dosage form, particularly early in the drug-development process. Often development of age-appropriate dosage forms does not begin until after proof of concept, but a case...

White paper

Best Practices for Highly Potent API (HPAPI) Development and Manufacturing

Drug-product development for highly potent APIs (HPAPIs) is challenging. This executive summary in Japanese of our webinar provides best practices for developing and manufacturing highly potent compounds, infrastructure requirements that can facilitate de...

e-book

20 min read

Book Chapter: Leachables and Extractables: From Regulatory Expectations to Laboratory Assessment

During manufacturing, storage and administration, a pharmaceutical drug product (DP) formulation and its constituents are in contact with a multitude of polymeric materials. Every such contact leads to leaching of chemicals from the material into the ...

e-book

20 min read

Book Chapter: Parenteral Container Closure Systems

Parenteral container closure systems are in direct contact with the drug product formulation and can significantly impact the product quality. The interaction between the drug product formulation and the primary packaging components may also impact ad...