02.26.24 -- Novel Approaches For Obtaining High-productivity Clones

A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.

Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Learn how to troubleshoot these and manufacturing deviations that impact viral safety.

Understanding the key characteristics of an effective data management plan as they relate to contract service providers is important in developing an effective data management plan.

Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: next-generation Sequencing (NGS), bioinformatics, and computer system validation (CSV).

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end user.

Explore how the widespread adoption of auto-injectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Not all CDMOs are suitably equipped to handle aseptic processing and sterile F/F operations on a clinical and a commercial scale while offering robust safety measures and global reach.

Learn how we simplify bringing life-changing molecules to market, from preclinical to commercial, with our CTDMO services designed to support global clients.

Explore how a novel conjugation technology is enabling streamlined and cost-efficient production of antibody-drug conjugates (ADCs), driving the development of effective targeted cancer therapies.

Next-generation sequencing (NGS) delivers significantly more data than traditional sequencing methods, opening up a range of possibilities for the analysis of biologic therapeutics such as monoclonal antibodies or viruses.

Learn how our robust analytical and GMP manufacturing services can enable cost-effective, flexible, and accelerated support for preclinical to commercial supply.

Catalent Biologics is poised to advance your product with speed. Leverage our robust filling lines and proven expertise in commercial manufacturing to successfully deliver your critical medicines.

The BD UltraSafe Plus passive needle guard for prefilled ISO standard glass syringes is designed to support viscous drug delivery with ergonomics and drug visibility.