Whitepapers

Accelerate your viral vector and vaccine development with high-performance media, supplements, services, and support. Discover our extensive, cutting-edge portfolio, including Gibco™ Bacto™ CD Supreme, the first chemically defined microbial media, designed to support high cell density cultures of E. coli. Read the brochure to explore how you can optimize your workflow, while minimizing risks and improving cost effectiveness.

When choosing a CDMO to work on a project, there are a number of important areas to consider prior to making a selection

Despite the long-standing popularity of E. coli for microbial bioprocessing, the options for growth media have been traditionally limited. This media has often included animal origin (AO) components which can reduce batch-to-batch consistency and present safety risks to patients. Significant effort from across the industry has been focused on developing the first commercially available chemically defined microbial media. Read the article and learn how the Gibco™ Bacto™ CD Supreme Fermentation Production Media is helping to manufacture the next generation of biopharmaceuticals.

The cell and gene therapeutic market is growing substantially and finding a way to increase manufacturing capacity while maintaining high-quality standards poses a unique challenge. With a focus on maintaining consistency, utilizing a fully chemically defined medium, such as Gibco™ Bacto™ CD Supreme, can help to mitigate variability risks. Read the whitepaper to explore scalable process workflow solutions available from initial R&D investment to clinical testing, and commercialization.

Timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market. Streamlining chemistry, manufacturing, and controls (CMC) development can help accelerate this process, as well as help yield better success as the drug product moves through the early phase of clinical studies.

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.

For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully cGMP-compliant Viral Safety Services, including characterization of cell banks, unprocessed bulk testing, end of production cells, and raw materials testing.

Eurofins BioPharma Product Testing supports the development of cell & gene therapies by providing comprehensive GMP-compliant CMC testing support to ensure the identity, potency, purity, and safety.

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.

Scaling production of mAb drugs remains a critical industry challenge – especially in downstream process chromatography steps. This Avantor White Paper details how technologies such as a novel protein A chromatography resin and the use of additives can improve efficiencies in this complex process step. It also reveals the potential for expanding single-use and continuous processing systems to help further streamline downstream production and improve cost profiles.

Finding more efficient ways to reduce processing times and improve downstream yields is a major bioprocessing industry challenge. In this study, two mAbs chromatography resins were examined. Both were used for a capture step, and additives were screened to reduce the nonspecific binding of impurities. The goal of the study was to optimize chromatography steps and thus increase the capacity and removal of impurities.

Traditionally, Oncology trials placed a heavy burden on patients due to travel burden, poor patient experience and multi-year clinical trial commitments. Sites also struggle with cancer trials due to enrollment delays, complex data workflows, and multiple amendments requiring re-consents. Today, we have a more effective, patient-first solution. Optimize patient choice, improve retention and safety with Patient- First Oncology solutions that meet patients where they are.

This white paper will describe the critical factors to consider for the identification and implementation of catalytic processes using supported Platinum Group Metal (PGM) heterogeneous catalysts. Many variables influence catalyst performance. The paper will provide guidance for catalyst selection and how through an in-depth analysis can lead to process optimisation.

The successful transition of drug products between developers and manufacturers is equal parts science and art, defined by enabling processes, a culture of collaboration to support them, and, perhaps most important, a foundation of trust.

Risky Assumptions for Addressing Limited Bioavailability

Whether it’s for scaling-up, moving to another facility, or moving to another outsourcing partner, technology transfers are part of the normal course of business. Learn about the 9 dos and don’ts of executing a successful technology transfer.

Small molecule drug development has changed substantially in recent years. With the heightened focus on molecularly targeted therapies, small molecule active pharmaceutical ingredients (APIs) and drug products are more complex and potent than ever, requiring increasingly specialized manufacturing processes and drug delivery solutions. At the same time, the competitive demand for rapid entry into clinical development—combined with accelerated review pathways—translate into compressed manufacturing and delivery timelines.

Outsourcing projects to CDMOs is becoming increasingly prevalent as drug sponsors look to optimize their supply chain or conserve internal resources for other projects. In 2021 alone, 46% of newly developed drugs were outsourced. Drug sponsors can reap a variety of benefits by outsourcing late-phase projects, but it comes with risks. The technology transfer that must occur to transition a late-phase project to a CDMO is complex and costly. The average cost of a tech transfer is around $1M, so partnering with the wrong CDMO can be a costly mistake.

In the race to market, you need fast, cost-effective, and scientifically proven solutions to seamlessly guide your molecule through early-phase development. Explore these five flexible solutions that enable you to move your molecule through each early development phase with efficiency and speed.

Advancing Drug Development Using in Silico Modeling

Today’s pharmaceutical manufacturers are under more pressure than ever to deliver treatments quickly and cost-effectively around the globe. Find out how implementing in-line, real-time closed-loop process verification and control can help.

If you’re in the business of pharmaceutical product development or manufacturing for the US market, this brief talk by Dr. Richard Sidwell is for you. The need for pharmaceutical products is higher than ever. At the same time, the ability to develop and supply new products is being constrained by demographics, geopolitics, energy, and inflation. This is why it’s more important than ever to strategically invest in CMC development and engineering, onshoring, and thoughtful supply chain design. Dr. Sidwell discusses recent trends in drug product development and manufacturing given the current demographic, geopolitical, and macroeconomic trends.

When looking to scale-up monoclonal antibody (mAb) manufacturing, a crucial challenge can be delivering sustained or improved product quality with productivity enhancements. Having consistent product quality is essential to ensure patient safety and product efficacy. Manufacturers are therefore placing greater emphasis on optimizing upstream processes. Developed using an advanced multi-omics and bioinformatics modelling approach, the Gibco™ Efficient-Pro™ Medium and Feed System has been specifically formulated to help address productivity and quality challenges. This complete solution brings together two high-performance products, working in total harmony, to accelerate your workflow into a new era. Read the app note and discover the future of mAb manufacturing.

Learn how STARMAP® Online cultivates an advantageous outlook for customers through accessible CESS®-powered nanoparticle technology. This platform can reduce the time, cost, and risk of drug development, as well as use AI to assure data privacy and streamline decision-making for patients.

Learn about the benefits of tailored active pharmaceutical ingredient [API] nanoparticles in this webinar with Christopher P. Worrall, Ph.D. This presentation looks at how API nanoparticles enable patient-centric therapies and benefit many dosage forms, as well as how industry collaborations drive novel drug delivery approaches.

Learn how TargTex partners with Nanoform to produce therapies for Glioblastoma patients. This process includes identifying novel targets with small molecules, utilizing Nanoform technology to increase the active pharmaceutical ingredient [API] concentration, and improving treatment stability to move the drug to clinical development.