08.05.22 -- Critical Risk Assessments With CDMOs

With increasing molecule complexity posing growing challenges for formulation and manufacture, oral solids specialists require extensive expertise and cross-team collaboration to ensure project success.

This article discusses the manufacturing challenges and highlights the key considerations when evaluating product development tools, selecting equipment, and optimizing small-batch fill/finish lines.

ISR split the data from its most recent Biologic API CDMO Benchmarking report by large and non-large respondents to highlight the differences in outsourcing preferences and practices.

Although most current legislation concerning traceability of pharma products focuses on serialization rather than aggregation, the latter is an essential component of internal and external traceability of products.

When replacing your CRO becomes the only feasible option, a partner experienced in such transitions — as well as sensitive to the impact on your timeline and costs — is invaluable.

In this article, we cover the basics of manufacturing these tablets that start out in research and development, an independent lab, a CDMO, or brand name manufacture.

We take a deep dive into real-time visibility and consider the top needs faced by three major players in pharma manufacturing: quality assurance, supervisors, and operators.

An introduction to the principles and practices of bulk solids feeding.

Patients want a better quality of life and more freedom of choice, and manufacturers want to fulfill this wish with flexible equipment. Self-medication is a good example of how this can be implemented.

Informed quality leaders who stay abreast of the trends shaping the industry’s future will be critical drivers of transformation, versatility, and success within their organizations.

To evaluate whether a perfusion application will work in a production process, standardized terminology is critical. This white paper explains key terms that are essential for understanding the process.

Meeting demand for high-quality, adeno-associated virus requires scalable, cost-effective production. The process we developed optimizes each step from suspension cell culture to purified bulk.

Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost-efficiency, supply chain continuity, and patient benefit.

Review key approaches and technologies that enable a DNA to IND timeline, with case study examples for application in vector, process, analytic, and formulation development of bispecific molecules during preclinical development.

Learn alternative technology options and data integrity compliance capabilities that are critical to CCIT due to a wide variety of applications and regulatory requirements.