Whitepapers

Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.

Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, and quality of advanced therapies, supporting your journey from product development through regulatory approval.

Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.

Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.

Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process design and qualification, a robust validation strategy can be developed to support flexible, scalable manufacturing for small-molecule drug products.

Parenteral drugs are becoming increasingly complex, creating new challenges and opportunities. This paper explores potential innovations across the entire value chain.

Despite selecting the right, compendial excipients for a balanced formulation, you may encounter obstacles that delay market deadlines. Learn how to streamline the formulation and fill-finish process with the right raw material selection, secure and efficient fluid pathway design, comprehensive regulatory support, and supply chain transparency.

Biopharma companies often lack the capacity and infrastructure to handle large buffer volumes needed for mAb production. Avantor offers four key strategies to improve operational efficiencies and reduce facility footprint, such as pre-weighed, GMP-compliant raw materials or ready-to-use hydrated solutions. Learn more about these customizable solutions.

The growing complexity of therapeutic monoclonal antibodies (mAbs), especially bispecific antibodies, presents significant manufacturing challenges such as instability, low yields and aggregation. This article explores innovative solutions, including detergent-based viral inactivation as an alternative to low pH treatment, high- performance chromatography ligands and advanced formulation excipients.

Scaling up monoclonal antibody (mAb) production can be challenging, but it doesn't have to slow you down. Explore how our large-volume handling solutions, GMP-grade chemicals and customized solutions for process development, optimization, and validation help you scale up quickly and meet regulatory standards with confidence.

Can biopharma manufacturers avoid extra costs, potential problems and wasted production time by designing a fully compliant (cGMP) manufacturing process early on? This article explores where planning ahead, using compendial raw materials of the highest quality and purity, can yield substantial benefits to both productivity and patient safety.

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever. This ebook provides a comprehensive roadmap for understanding nitrosamine risks and offers actionable strategies to mitigate potential impurities. Through expert insights from Adare Pharma Solutions, you’ll learn how to remain compliant, identify risks, and implement cutting-edge strategies for nitrosamine mitigation.

Looking to improve drug product effectiveness and differentiate? Mucoadhesion – the ability of a formulation to adhere to a mucous membrane – is an attractive option for those keen to ensure their products stand out in a crowded market.

Carbopol® polymers are efficient suspending agents that simplify manufacturing and improve the dosing experience for pediatric and geriatric patients. They offer excellent performance and versatility as pharmaceutical suspending agents for oral liquid formulations. They are compatible with various APIs, flavors, and preservatives and also provide a reliable supply. In this webinar, the Lubrizol team together with the IMCD team takes you through formulation aspects of Carbopol® polymers as well as the results of a case study on an Acetaminophen oral suspension formulation.

This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion. The basic mechanism of mucoadhesion and methods to evaluate it in the context of pharmaceutical applications will also be reviewed, also how it can improve and differentiate drug products.

Cell-based assays (CBAs) are key tools for evaluating the potency of new biologic drugs. Catalent’s transcription-based bioassay simplifies and empowers the testing of new biologics.

In this rapidly changing environment, your choice of CDMO partner is critical. The right partnership can serve as your key to commercial success, while the wrong one can lead to costly delays, quality issues and compliance risks. To help you overcome your OSD challenges and drug product manufacturing challenges and streamline your journey to commercialization, our experts have developed an eBook to help you find the right CDMO for your project.

This whitepaper explores the importance of safe cGMP pharma product storage, highlighting challenges CDMOs face with inventory bottlenecks and delays. It examines off-site cGMP storage benefits, including cost savings, flexibility, and compliance, while addressing key factors for maintaining product safety and accessibility.

Elemental impurity testing is essential to deliver safe drug products to patients and is a regulatory requirement. It is important to assess the risk of elemental impurities from all sources in the manufacturing process, including process equipment, water, container/packaging, raw materials, drug substances, and the final drug product.

Compendial testing covers a wide array of materials, subjects, and locations designed to create standards and programs that ensure the quality and safety of approved articles for a geographical location or areas such as USP (For the United States market) or Ph Eur (For European markets). The compendia provide monographs and test methods for active ingredients, raw materials, drug products, utilities (water and gases), and packaging components.

Revolutionize pharmaceutical manufacturing through paperless manufacturing. By eliminating paper-based processes, you can quickly centralize your data, reduce cost and time, minimize errors, and release products faster. Even the simplest “paper on glass” digital systems enable streamlined workflows and can ensure real-time data access and seamless communication. Paperless facilities are a reality! Transform your operations today!

Amid surging drug shortages and costly launch delays, it’s crucial to enhance operational flexibility and efficiency without compromising quality. Discover how end-to- end integrated automation systems can streamline your processes, improve flexibility, reduce time-to-market, maximize revenue, and drive continuous improvement. Transform your pharmaceutical manufacturing processes today!

This case study explores the deployment of an innovative logistics solution designed to support the survival of premature infants through the rapid collection, retrieval and delivery of essential, temp-sensitive supplements to hospitals in Sydney, Australia. Storage specifications for the supplements was -20°C with instant availability required upon order. Retrieval was immediately followed by expedited delivery at -80°C with dry ice. Executed by Marken, this project required a comprehensive system enabling immediate access, and transportation of these critical supplements, ensuring they reach newborns in regional hospitals when every second counts.

Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.

Harmonizing technological innovation and a platform approach in biomanufacturing can reduce time and cost barriers to produce stable, high-expressing antibody-based therapeutics