01.12.21 -- 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement

Several assumptions based on previous knowledge or experience regarding lyophilization are often made, but as with many techniques that have become well-developed over time, there remains a number of misconceptions that persist in this process. This tech note summarizes two webinars and includes a selection of questions from the Q&A sessions from the two-part series of webinars questioning ten assumptions that are made when developing the freeze-drying process for pharmaceutical products and how these may be counteracted.

While quality by design (QbD) evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?

Surplus and idle equipment can lead to decreases in workspace and work efficiencies for a manufacturing site. These surplus items of equipment often get in the way of operations. Read how you can get paid for them, clean up your workspaces, and reduce response time for things needed in production, all at the same time.

Optimizing the formulation of reagents for your qPCR assay requires careful experimental design that looks across several performance factors for each reagent formulation tested. These performance factors include assay specificity, reliability, repeatability, linearity, sensitivity, and efficiency.

Over the life of a drug, changes in raw materials are inevitable. But even a small modification can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.

Remote work increases the level of difficulty of proper data governance and security to prevent attacks such as hacks, ransomware, and data carelessness. Read how to mitigate the risks associated with the human side of data governance and information security.

Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal that your partner isn't carrying its weight on your journey to commercialization.

Quality risk management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its life cycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.

To execute process development effectively, life sciences organizations must understand the nuances associated with their products’ specific characteristics. In the case of fermentation, many industry processes and parameters are still in their nascent stages. Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.

Your future cleanroom is a critical asset; it is not just another construction project. The investment you make in the cleanroom facility is significant and it should perform for years to come. Learn the relative strengths and weaknesses of various cleanroom construction methodologies that are being implemented within the marketplace.

This study demonstrates integration of the HyPerforma Single-Use Bioreactor (S.U.B.) and how strategic enhancements to the sparger and agitation systems have revealed potential improvements.

Warm temperatures can denature some hormones and proteins, thus causing cleaning problems. A critical cleaning company gives insight on how temperature can affect enzymatic and emulsifying activity in cleaning mechanisms.

When it comes to outsourcing in medical device manufacturing, companies are faced with the decision to either use a selection of unrelated service providers or a single-source contract manufacturer that can handle every step of the process. While there are benefits to piecing together a group of discrete resources, there could be unintended consequences that could delay the project timeline, increase costs, and lower finished quality, in addition to creating undue workloads and stress for the internal project team. This article discusses these consequences and presents the advantages of working with a single-source contract manufacturer.

Given that the experimental design has only two conditions, leaking and nonleaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

Biomanufacturing is trending toward higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based columns.

Pharmaceutical and biotech companies are spending years and millions of dollars developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a race to the finish in some cases, and the quicker a company can get its product to patients the better. With additional novel drug products planned for approval over the next few years, along with new and emerging modalities, it is imperative that companies invest adequate time and resources in strategic planning and preparation activities to ensure the best chances for a successful commercial launch.

This webinar provides an overview of Thermo Fisher Scientific’s Quick to Care program. Watch it to learn how a single vendor with a cohesive global network can help you accelerate the drug development process and reach the market sooner.