Whitepapers

Solubility of the active pharmaceutical ingredient (API) in an oral formulation is critical for absorption from the gastrointestinal (GI) tract and the intended therapeutic effect. Ensuring that an API has the necessary solubility can be challenging for drug developers and formulators. If limitations in solubility cannot be successfully addressed, a new chemical entity (NCE) is unlikely to advance in the development pipeline. Addressing this potential roadblock to clinical success is becoming increasingly important as NCEs continue to become larger and more lipophilic and, as a result, less soluble.

Explore the potential of next-generation genome editing tools for driving the success of monoclonal antibodies for biotherapeutics.

Explore how Samsung Biologics’ DEVELOPICK™ can help mitigate development risk and identify candidates with the best potential for advancement to IND and beyond

Ashland has launched Viatel™ ultrapure bioresorbable polymers (lactide / glycolide / caprolactone chemistries), a higher purity platform of controlled release polymers used in long acting injectables and implants (LAII). Ultrapure provides improved release consistency, extended-release durations and are better suited for sensitive drug compounds due to the less acidic micro-environment.

In this application note, Pfizer CentreOne examines key considerations for the development and manufacturing of your unique sterile injectable.

It analizes how to optimize a bio-decontamination process using an atomized hydrogen peroxide new cycle development method for use in pharmaceutical aseptic enclosures.

Through in-depth interviews with leading global manufacturers, the International Data Center (IDC) established the impact TrakSYS has on manufacturing operations.

Vetting a CMO for sterile injectable fill finish means more than capacity and equipment. This white paper from Jubilant HollisterStier discusses the range of factors to consider when outsourcing manufacturing for aseptically filled and terminally sterilized products.

In this eBook learn more on how to expedite the development pathway for early phase compounds, and how lipid based formulations provide innovative approach to enhance bioavailability for challenging molecules. It also presents how the lipid-based delivery provides a tool for highly potent, poorly soluble, and unstable APIs.

Download the article to learn how lipid-based formulation allows for the timely completion of early and late-phase development activities, and provides relatively straightforward scale-up dosage form manufacturing to meet the commercial volume demand requirements for newly launched products.

The enteric delivery of pharmaceuticals has long been a challenge for numerous reasons, including protecting the active pharmaceutical ingredients (APIs) from the harsh environment of the gastrointestinal tract and assuring consistent delivery and dosage in the small intestine. This paper reviews the challenges and the science that shows Lonza’s proposed hard capsule solution has been validated to provide acid protection, customization, and scalability.

In this webinar, experts will provide an overview of why the properties and structure of pectin are well suited for site-specific delivery to the colon. In addition, experts will also provide insights into how softgel capsules, formed by the combination of both pectin and gelatin, are used in OptiGel® DR, a new delayed release delivery technology for pharmaceutical applications.

Developing and manufacturing highly potent oral solid dose drugs to respond to increasing demand in the industry requires specialized procedures and expertise.

In this application note, Pfizer CentreOne examines key considerations for the development and manufacturing of your unique sterile injectable.

When a large CDMO couldn’t give a mid-size pharma company the proper attention, Adare stepped in to help manufacture CTM batches and get their project to the clinic quickly.

A discussion of the FDA's guidance on nitrosamine impurities, various approaches for reducing the presence of impurities, and how Adare's unique nitrosamine mitigation process can help products achieve compliance.

In this article, gain insights into how early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals, and why collaboration with experienced partners like CDMOs is essential.

The Lonza Capsule Application Lab is uniquely focused on solving technical issues and creating new solutions related to dosage form and delivery. We work together to leverage our scientific and technical knowledge helping to improve your manufacturing process and methodology to deliver customized solutions.

This article addresses new alternatives in industrial refrigeration systems ready to comply with current and future regulations, applicable for both new and existing freeze

Understanding the impact of API solubility on the performance of a given drug product and determining ways to enhance dissolution rates is critical to ensuring your product makes it to market, into the hands of patients and clinicians, is well absorbed and provides its intended therapeutic effect. Selecting the best formulation strategy to address challenges for each API, however, can be time-consuming, costly and complex.

When it comes to viral vectors, the complexities related to varying serotypes and different sized payloads continue to impact efficiencies and timelines. Hear from Resilience experts on how innovative platform technologies can overcome these challenges and support scalable manufacturing.

Designed for advanced therapy manufacturing, the Marlborough, MA facility is the first new construction at Resilience. The site will produce, rest, and release viral vector drug substance (DS) and drug product (DP), for clinical and commercial use.

Understanding the impact of API solubility on the performance of a given drug product and determining ways to enhance dissolution rates is critical to ensuring your product makes it to market, into the hands of patients and clinicians, is well absorbed and provides its intended therapeutic effect. Selecting the best formulation strategy to address challenges for each API, however, can be time-consuming, costly and complex.