Whitepapers

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.

During therapy manufacture, consumable stability is vital to ensure flexible material handling and consistent results. This is particularly true for cell culture media, which is volumetrically the largest bioprocess material component, especially in perfusion workflows. In our new study, we explore the shelf-life of reconstituted Gibco™ High-Intensity Perfusion CHO Advanced Granulation Technology (AGT™) media (HIP CHO AGT media). Chemically defined and animal origin-free, this easy-to-use perfusion medium can provide flexibility with excellent post-reconstitution stability and help you achieve high titers in your CHO cell lines. Discover how HIP CHO AGT media can support the optimization of your monoclonal antibody (mAb) manufacturing.

Learn more about the Capsugel® Enprotect™ capsule An innovative capsule for enteric delivery with no additional coating required for low pH protection.

Learn more about the Capsugel® Enprotect™ capsule and our breakthrough enteric manufacturing technology.

This article proves the viability of including a catalyst in a nebulized hydrogen peroxide recirculated system and the low impact in complete cycle times.

Important considerations regarding the production of high-quality empty hard capsules, critical excipients of finished pharmaceutical products.

A primer for understanding these remarkable therapies and their impacts in clinical trials.

Learn how the right integrated CDMO can help small biotech companies move a project into and through the clinic and onto the market with ease.

Automated method development and robustness workflow for Triumeq and related compounds using ChromSwordAuto and Thermo Scientific Vanquish Core HPLC

Improve process productivity and performance with the state-of-the-art Gibco™ Efficient‑Pro™ Medium and feed system. Formulated to work in perfect harmony, the system comprises the high-performance Efficient-Pro Medium and a choice of two premium feeds—Gibco™ Efficient-Pro™ Feed 1 for CHO-K1 cells and Gibco™ Efficient-Pro™ Feed 2 for CHO-S, CHO-GS, and CHO-DG44 cells. Watch our how-to video to learn how the system can help simplify your process and elevate your monoclonal antibody (mAb) quality and titers. Utilize our specialized insights to develop your optimal Efficient‑Pro feeding protocol and maximize the benefits of choosing the Efficient-Pro™ system. Revolutionize your process with a cutting-edge media and feed system, designed to accelerate your mAb manufacturing workflow and transform your process performance.

The update for EU annex 1 is more than a simple revision, solidifying the expectation that facility fully understand their processes and systems.  

Discovery the industry's best kept secret...a fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing, and fill/finish cGMP manufacturing for sterile injectable and topical products – all under one roof. Whether your drug product is liquid or lyo, aseptically filled or requires terminal sterilization, the August Bio team brings to bear more than two decades of drug development and launch expertise. Supporting projects from preclinical to clinical to commercialization and with new multiple high-speed filling lines (vials, syringes, IV bags), August Bio also offers the rarest of CDMO attributes today - immediate, available capacity.