Whitepapers

This whitepaper explores the criteria for defining true quality in a CDMO partnership, including multiple product, process, and relationship variables

Biotech, BioPharma’s, CDMOs, CROs who are investigating promising nucleic acid-based drug candidates like vaccines, mAbs, and other biologics & biosimilars must go through stringent quality control checks for their molecular entities to ensure safety & efficacy of their drug candidates. Explore the best quality control workflows using QualTrak qPCR ecosystems. Learn more inside this eBook about the benefits of:

Implementing a proper contamination control strategy (CCS) helps ensure product quality and patient safety. Additionally, it is a core element of good manufacturing practices.

Analytical Method Development for Synthetic Peptide Purity and Impurities Content by UHPLC - Illustrated Case Study

KBI Biopharma has created a platform E.coli resulting in a PURE, efficient platform expression strain - PUREcoli™ - to reduce impurities and reach higher titers.

This executive summary highlights strategies that can be used to maximize long-acting parenteral formulations using nanoparticles, microspheres and in-situ forming gels.

A company focused on the treatment of advanced solid tumors, partnered with Catalent for the development, clinical trial supply and scale-up of a spray-drying program.

Discover how to use enteric polymer coatings effectively for controlled drug delivery in oral medications to enhance your drug formulations.

In pursuit of increased competitiveness and bottom-line impact, pharmaceutical manufacturers face increasing pressure to fast-track technological innovation while maintaining regulatory compliance. This e-book explores how Artificial Intelligence (AI) can unlock new levels of insights into what is causing variation in processes that can wreak havoc on your drug manufacturing performance. Learn how to use AI so you can improve your manufacturing operations in GxP environments that are capable of delivering real returns on Pharma 4.0 technology initiatives.

How to Craft a Successful Orphan Drug Designation

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.

From stumbling over a journal article in a library to developing a new form of analytical technology, Sean Hart, PhD, covered an exciting journey with laser force technology.

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.