Whitepapers

Oligonucleotides are a class of biotherapeutics presenting complex challenges in the development and commercialization of gene therapies. Download our paper and learn how to move your project forward.

Speed is a critical factor in early-stage development. Solid state studies within an integrated CMC platform can support formulation development, accelerate timelines to Phase I clinical studies and increase the likelihood of successful clinical trial results.

Process equipment used in the healthcare and pharmaceutical industries follow rigid specifications for accuracy, consistency and cleanliness.

This case study shares why a leading biotech company reached out to Aizon to identify how artificial intelligence (AI) could be used to further optimize yield. The team was able to analyze five years of historical batch data to discover a direct correlation between hold up volume and time between process operations as well as generating millions of additional recovered revenue.

Real-world examples that demonstrate the value of using AI in GxP compliant manufacturing environments.

The lab of the future is about the whole enterprise. It generates business value by using advanced digital tools and techniques to make contextualized, actionable scientific data available at the bench, in the executive boardroom, and wherever that data can help generate revenue, accelerate innovation, and drive meaningful business decisions. This paper will help you keep up—and even get ahead—in a future that’s rapidly approaching.

The term “digital transformation” attracts a lot of hype. No wonder: the modern gleam of digital and the big-picture promise of that word transformation are irresistible. So much of that hype is based on speculation and inflated claims, though. This paper is your answer. It provides a hype-free account of three transformational projects undertaken in three intensely competitive industries.

The efficiencies and insights of artificial intelligence (AI), machine learning (ML), predictive analytics, and other emerging technologies offer abundant opportunities to laboratories. To help customers leverage digital transformation and prepare for the lab of the future, LabVantage Solutions has devised a five-step process for successfully implementing and profiting from AI in the lab.

The increasing number of breakthroughs in small molecule drug development are exciting, but corresponding workflows are complex and require much more tailored approaches to ensure successful upstream and downstream processing, drug approvals and commercialization.

Enteric polymer coatings play a crucial role in oral drug formulations, protecting the active pharmaceutical ingredient (API) from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location. By selecting enteric coatings, formulators can ensure the protection of their acid-sensitive APIs and create a controlled release drug delivery system. With the latest polymer coatings technology, there's no limit to the precision and adaptability that can be achieved in drug formulations. This white paper provides valuable insights into the successful application of enteric polymer coatings for controlled drug delivery systems. Discover how this innovative technology can transform your oral drug formulations.

New drugs receiving expedited approval have shorter timelines, which can create unique challenges for development and manufacturing. Learn how to leverage the drug development knowledge and build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process. Download the executive summary to get expert insights on overcoming manufacturing challenges associated with expedited development programs.

This eBook includes an overview of outsourcing trends in the oral solid dose market. Featured articles describe the robust market resulting from the demand for specialized dosage forms such as controlled release, pediatric and geriatric delivery vehicles.

The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition. The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this executive summary, experts will demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs) and their impact on the finished dosage. In addition, the experts will explain how these approaches can facilitate in the tech transfer of a program. Lastly, this executive summary includes an overview of Catalent’s oral solid dose turnkey solutions featuring advanced oral solid dosage (OSD) manufacturing technologies and expertise throughout an extensive global network.

A panel of experts from bio/pharmaceutical companies discuss plasmids to establish specifications using a risk-based approach to manage supply, including the response to cell & gene therapy industry feedback, future outlook and re-evaluating plasmid risks.

The Eurofins BioPharma Product Testing (BPT) lab in Portage, MI, is expanding its capabilities in raw materials testing through collaboration with its Lancaster, PA, site. With a surge in demand for raw materials testing, BPT aims to enhance business continuity and deliver seamless services. This expansion aligns with Eurofins' commitment to meeting clients' testing demands efficiently and maintaining high-quality results.

Eurofins BioPharma Product Testing’s Biologics Raw Materials testing team has vast experience in cell & gene therapy testing, including evaluating critical quality attributes for ancillary and raw materials.

No bio/pharmaceutical product can be manufactured without first establishing the identity, purity and quality of its starting materials to ensure the product is suitable for its intended use. This guide covers all testing and considerations for raw materials supported at Eurofins BioPharma Product Testing.

International Journal of Pharmceutics: In Vitro: The dissolution characteristics of five capsules (Next Generation Enteric [NGE], Vcaps® Enteric [VCE], VCE DUOCAP® [VCE/VCE] system, Hard Gelatin Capsule [HGC] as negative control, and Creon® 10,000 U as market reference) were evaluated using an in vitro simulation of the stomach and upper intestinal tract with an acidic duodenal incubation (pH 4.5 for the first 10 min, pH 6 for the remaining 17 min) to simulate exocrine pancreatic insufficiency. Caffeine was a marker of capsule dissolution, and tributyrin to butyrate conversion measured pancrelipase activity. All capsules were filled with pancrelipase; the NGE, VCE, VCE/VCE, and HGC capsules also contained 50 mg caffeine. Caffeine was released first from the HGC capsule, followed by the VCE, NGE, and VCE/ VCE capsules. Pancrelipase activity followed this trend and demonstrated a similar activity level over time for the NGE, VCE/VCE, and Creon® capsules. The HGC formulation confirmed gastric degradation of unprotected pancrelipase. NGE capsules provided similar protection to the simple fill formulation as observed for the complex formulation of the Creon® capsule in a setting with increased pepsin activity and may hasten the time needed to go from formula development to first-in-human studies for pH sensitive drugs or those requiring small intestine targeting.

Introducing Lonza Capsules & Health Ingredients' groundbreaking enteric manufacturing technology - the Capsugel® Enprotect® capsule. This unique bi-layer capsule with the Coni-Snap® secure closure design utilizes HPMC and HPMC-AS polymers. It protects acid-sensitive APIs and enables rapid dissolution release at pH 6.8 without the need for additional excipients. The bi-layer manufacturing technology streamlines drug development processes, while personalized oral dose customization enhances product differentiation. Partner with us to revolutionize the microbiome market, overcome enteric delivery challenges, and drive innovation in modern healthcare.

Invivo: Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach. However, an enteric formulation is often accompanied with a higher development effort in the first place and the potential degradation of fragile APIs during the coating process. Ready-to-use enteric hard capsules would be an easily available alternative to test and develop APIs in enteric formulations, while decreasing the time and cost of process development. In this regard, Lonza Capsugel® Next Generation Enteric capsules offer a promising approach as functional capsules. The in vivo performance of these capsules was observed with two independent techniques (MRI and caffeine in saliva) in eight human volunteers. No disintegration or content release in the stomach was observed, even after highly variable individual gastric residence times (range 7.5 to 82.5 min), indicating the reliable enteric properties of these capsules. Seven capsules disintegrated in the distal part of the small intestine; one capsule showed an uncommonly fast intestinal transit (15 min) and disintegrated in the colon. The results for this latter capsule by MRI and caffeine appearance differed dramatically, whereas for all other capsules disintegrating in the small intestine, the results were very comparable, which highlights the necessity for reliable and complementary measurement methods. No correlation could be found between the gastric residence time and disintegration after gastric emptying, which confirms the robust enteric formulation of those capsules

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.

Once APIs move into later phases of development, an advanced impurity control strategy is vital and demands a comprehensive analytical methods approach.

Oral administration is the preferred route of delivery for therapeutic molecules due to its convenience. However, most New Chemical Entities (NCE) exhibit physico-chemical properties limiting their absorption in the gastrointestinal (GI) tract, with almost 70% of identified molecules facing solubility issues in aqueous GI fluids according to Pharmacircle data from March 2022. Lipid-based formulations (LBF) is an interesting approach to enhance oral bioavailability of poorly water-soluble (PWS) drugs, including small molecules and macromolecules such as peptides and proteins.

Expand your mAb NBE candidate pipeline numbers by leveraging ProtaGene's flexible analytical capacities. Get a complete overview of ProtaGene's end to end services.

Long-acting products, such as Long-Acting Injectables (LAIs) and implantables, have gained significant traction in recent years, revolutionizing patient treatment and medication adherence. By reducing the number of doses required, long-acting products improve patient compliance and eliminate the risk of missed doses. Moreover, they minimize toxicity and side effects, offering a more comfortable patient experience. This article delves into the numerous benefits of long-acting drug delivery systems, including their ability to harness highly potent APIs, streamline development and intellectual property protection, and provide consistent drug release over extended periods. You’ll explore their applications in various medical fields, such as CNS disorders, cancers, diabetes, substance abuse, eye diseases, HIV treatment and prevention, and contraception. Discover how Lubrizol Life Science – Health overcomes challenges in developing these innovative drug delivery systems and gain insights into successful long-acting drug development. Whether you’re a healthcare professional, researcher, or simply curious about the future of medicine, this article offers valuable knowledge and opens up new possibilities in patient care.

Iterion Therapeutics, a clinical stage biotechnology company, is dedicated to developing novel cancer therapeutics for a broad range of cancers. When Iterion’s lead product, Tegavivint, demonstrated low solubility in water, they needed a partner who could not only solve their bioavailability challenges, but also develop a scalable formulation with a viable manufacturing strategy. They turned to the experts at Lubrizol Life Science Health (LLS Health). In this case study, you’ll learn how LLS Health combined its nanomilling expertise and GMP manufacturing capabilities to maximize bioavailability, improve patient experience, and take Iterion’s poorly soluble compound into clinical studies

CONRAD is a biomedical research and development organization dedicated to improving the reproductive health of women, especially in developing countries. They have developed a first-in-class, multipurpose intravaginal ring (IVR) that combines levonorgestrel with tenofovir to provide contraception while preventing against acquisition of Human Immunodeficiency Virus (HIV) and Herpes Simplex Virus (HSV). To bring this novel concept into the clinic, CONRAD needed the support of a contract development and manufacturing organization (CDMO) with specialized expertise in long-acting implant and IVR development. Lubrizol Life Science – Health was able to provide CONRAD with comprehensive support throughout the project from technology transfer to manufacturing. Their experts were proactive and creative in streamlining manufacturing of the product, and they integrated quality control and assurance from the very beginning of the project. As a result, we helped CONRAD to bring a novel, life-changing product to the clinic, and they are committed to helping other organizations develop and commercialize innovative drug eluting devices (DED).