Whitepapers

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.

When life science facilities are forced to shut down, or operate with fewer staff, it exposes a severe lack of capabilities to monitor critical assets and environments. This white paper states critical parameters in a lab or life science facility that should be monitored by a 24/7 real-time data acquisition system.

Validation is an important process to ensure cleanrooms meet specific standards. A comprehensive cleanroom monitoring strategy combines data acquisition, analysis, and reporting to support compliance efforts and protect valuable scientific work. Read how continuous monitoring supports validation and compliance in our white paper.

How do you ensure an environment remains controlled at all times? What parameters must be monitored to ensure scientific assets are free of the threat of contamination? Learn this and more in this eBook.

Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols during the first two years of the pandemic necessitated adopting unique commissioning approaches. Developing standardized factory acceptance test (FAT) execution approaches fit for the current times can allow for consistency across equipment vendors and their biopharmaceutical clients. This article describes pragmatic best practices that would support the momentum for new domestic manufacturing facilities.

Since 2020, the CDMO landscape has undergone significant changes. Dearth of fill/finish capacity in the US, exacerbated by COVID and vaccine production, caused market dislocation but also opportunity. With insights gathered through a blind, independent “voice of the customer” industry survey, discover what over 300 decision makers had to say about post-COVID trends and outsourcing plans. Among the intriguing responses captured in the survey – nearly 80% of respondents expressed they were open to, or actively looking for, new CRO/CDMO partners over the past 12 months.

Learn how Gibco™ Rapid Prototyping can help idenitfy the most feasible cell culture media for cGMP scale-up.