Process and Scaling

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

This latest round of funding adds 14 new technology projects, workforce development, and Global Health Fund projects to NIIMBL's portfolio.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Regulators have exaggerated expectations for simulated media fills.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Bioprocessing advances improve product yield, cut costs, and streamline integration between upstream and downstream processes.

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.

Analyzing process and equipment data provides insights that can improve quality and productivity of pharmaceutical manufacturing.

The technology center is dedicated to developing greener, safer chemistries for manufacturing pharmaceutical raw materials and intermediates.

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.

Advanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

The partners have developed a scalable, cost-effective purification process for adeno-associated viruses.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

Systems-based pharmaceutics case studies, challenges, and new uses were discussed at PSE’s Advanced Process Modeling Forum.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline.

As tests at GSK have shown, integrating powder testing into overall operations can optimize process understanding, and with it, raw material selection, equipment design, and process development.