Whitepapers

Bill speaks on our Winnipeg site’s historic excellence in bringing product from development to commercialization.

This multi-pager tells the story of Emergent’s Strategic Manufacturing Partnerships, highlighting our capabilities, unique partnership models, and history of manufacturing excellence.

Discover how pharmacy-led models in direct-to-patient clinical supply are pivotal in modernizing clinical trials, offering scalable, patient-centric solutions that align with regulatory guidance and industry trends. Strategic collaboration with pharmacy providers is the key to unlocking the full potential and benefits of decentralized clinical trials (DCTs).

Global decentralized trials require fast, efficient, and sustainable clinical supply solutions. This case study shows how a biopharma company worked with Catalent’s FastChain® demand-led model to improve supply by reducing waste and shipments by 40%, speeding patient dosing to under three weeks, and enabling flexible, decentralized packaging and distribution, whilst supporting an eco-friendly trial management worldwide.

Learn how scalable single-use systems can support reliable process performance and manufacturing flexibility.

Choosing the best location for packaging and distributing clinical supplies depends on various study factors and business needs. There’s no one-size-fits-all answer, but by evaluating key considerations, sponsors can determine whether the EU or non-EU countries like the UK best fit their clinical supply strategy.

China is a key player in global clinical trials, yet its intricate regulatory environment and logistical challenges demand meticulous supply chain management. Catalent provides tailored services such as Free Trade Zones, temperature-controlled shipping, and local comparator sourcing to support sponsors in executing trials effectively and in compliance with regulations.

Discover how automated plasmid purification can free up your lab's workflows and increase efficiency, scalability, and consistency without compromising quality. Get your copy of our eBook to explore real-world insights, actionable strategies, and innovative products you need to future-proof your pDNA purification processes.

Plasmid DNA purification has a vital role in molecular biology research. pDNA isolated at maxi scale is utilized in a variety of downstream applications, including mRNA synthesis, vaccine development, antibody production, cell and gene therapy and viral vector production. Learn about this new automated process.

Watch this webinar on how to improve your plasmid DNA research using automated and high-throughput extraction methods that are now available. High yield maxi prep can be hands free, and high-throughput pDNA midi prep is possible with magnetic bead-based technology.

Decentralized clinical trials (DCTs) can be enhanced to achieve greater efficiency, compliance, and patient accessibility, which can be done by implementing direct-to-patient (DTP) clinical supply, especially the pharmacy-led model.

Globally, scientific labs generate unprecedented volumes of data through cloud-based platforms, yet most of this valuable information remains fragmented and buried across different systems. While traditional software-as-a-service (SaaS) solutions have addressed the accessibility problem, labs still struggle with data overload, forcing scientists to spend countless hours searching for information that should be readily available. This whitepaper presents AI-powered SaaS, the next advancement in lab informatics that is transforming how lab workers interact with their data, enabling natural language conversations that deliver contextualized insights exactly when needed.

Optimizing process productivity, improving scalability and increasing efficiency are all important steps to developing a biopharmaceutical manufacturing process and high-performance Chinese Hamster Ovary (CHO) media feeds, supplements and kits can help developers achieve these goals.

An interview with Dr. Evan Zynda – an expert in the cell therapy process development and manufacturing workflow – on some of the key areas of innovation within the cell therapy industry and where it’s headed in the future.

Cell therapy is set to transform the treatment of diseases across a diverse range of therapeutic areas. But, to meet these needs developers need to be ready to innovate and carve a path to success.

Preparing your cell culture process for scale up from the start can reduce the risk of delays, mitigate costs and rapidly deliver life-changing therapeutics to patients.

From automated processes and modular instrumentation to specialist regulatory support, discover how you can streamline your workflow and set the pace in cell therapy.

This eBook explores how advanced particle analysis technologies are revolutionizing biologic drug development. It highlights the importance of accurately identifying and characterizing subvisible particles to ensure drug safety, stability, and regulatory compliance. Techniques like Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM) are often used for their capabilities in detecting protein aggregates and degraded excipients such as polysorbates. Case studies and experimental results demonstrate how these tools provide high-throughput, low-volume analysis that enhances decision-making in formulation screening and manufacturing.

Small pharmaceutical companies are constantly seeking innovative solutions to streamline early clinical trials. Adaptive clinical trials offer important benefits to sponsors and patients, both from a commercial and ethical standpoint. These trials offer flexibility and efficiency, especially in the early stages, where trial protocols can be adjusted based on interim data, such as introducing new doses or modifying participant sample size. However, adjusting manufacturing demand during an adaptive trial can be complicated, and strict regulatory requirements present significant challenges. On-demand manufacturing provides a robust solution, allowing for real-time supply and demand adjustments and improved trial flexibility. This paper explores how on-demand manufacturing meets the operational needs of adaptive trials and aligns with regulatory expectations.

Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.

In this case study, learn how TrueBinding leveraged G-CON’s prefabricated cleanroom PODs to achieve their mission critical goals.

In this webcast, we review industry drivers and risks for capital construction, with a focus on cleanroom infrastructure, and discuss the goals of using a hybrid approach while demonstrating its application and benefits using real-world examples.