11.12.20 -- Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products

Once deemed an experts-only approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis, including freeze-drying cycle optimization, lyophilization chamber moisture distribution mapping, and 100 percent moisture inspection of commercial freeze-dried product.

The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products in order to bring them to market faster.

“Business preparedness” is a term rarely used outside the boardroom, but in light of the COVID-19 crisis, it’s gaining new relevance. Currently, it’s on everyone’s agenda and at the forefront of most internal meetings.

When it was conceived by the Environmental Protection Agency (EPA) more than 30 years ago, “Green Chemistry” was intended to prompt solutions to real-world environmental problems resulting from industrial processes, emissions, and waste. These drivers remain as relevant now as they were then.

Biologics manufacturing subjects the formulation to different stresses and conditions that may compromise quality and stability. Read about the options provided by wearable technology that offers new alternatives that were not previously possible due to historically binding parameters for formulators.

Partnering with a CDMO requires a policy that addresses management responsibilities, risk management, documentation, change management, CAPA, process performance, and product quality. 

Advanced analytics is a key innovation for digital transformation. While many industrial companies are rolling out pilots and enterprise analytics projects, it is important for users to understand the features and capabilities of the analytics offerings.

This article presents a quality systems technique that is ideal for improving trust between a manufacturer and a supplier, as well as improving the overall quality of medical devices.

Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs), and greater flexibility. Continue reading in Part 2 of this series how, in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.

As this next wave of antibody-based therapies gains momentum, biochemists have begun to create even more innovative molecules with additional modes of action including multispecific antibodies and other so-called Frankenmolecules. However, informatics technologies have not kept pace with these scientific innovations.

The most recent innovations in injectable formulations are beginning to push the limits of many traditional drug delivery platforms. This article discusses the process used for the delivery of these formulations through developing an in-depth understanding of their properties and the unique challenges that they pose at the very earliest stage in the design process.

A single vendor offers access to a network of experts who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. 

Pharmaceutical manufacturers are striving for more diversified portfolios targeting a greater number of monoclonal antibodies (mAb); the key to driving down overall costs is to lower capital expenditure (CAPEX) investments by better utilization of equipment. This article provides an overview of a successfully designed closed and physically connected mAb process at the pilot scale with single-use components.

Key risks for drug contamination are by humidity, oxygen, or microbiological ingress, which can impact the drug stability throughout the product life cycle. 

A centrifuge is an integral component of a laboratory and is critical to the success of analysis. However, choosing the correct centrifuge for a particular application can be a daunting task.

The cell culture process is crucial for maximizing the production of biologics and vaccines, optimizing product quality attributes, minimizing impurities, and simplifying operations.

For many pharmaceutical companies that do not have their own facilities, choosing the right partner for late-phase clinical trials and commercial production is a critical aspect in the management of parenteral products. This webinar offers insight into the importance of looking for a partner with extensive experience in the parenteral arena as products move through clinical phases and toward commercialization.

Faciliflex Express is designed for cell and gene therapy companies that need to rapidly bring their therapies to patients. The traditional process of specifying a cleanroom has thousands of decision points. Hear how Faciliflex Express eliminates the guesswork and provides a proven off-the-shelf solution.