In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.

Lentiviral vectors (LVV) are a common vehicle to deliver genetic material in CAR T cell therapy and gene therapy applications. Production methods have been developed by adapting technologies from the bioprocessing sector. However, these downstream workflows are long, require substantial manual labor, and suffer from low yields of infectious virus. In this article we discuss process development pain points of a modern workflow and ways to address them.

Even for experienced teams, it can be tricky to balance the efforts of reaching the first clinical trial using a manual, open method with building a more commercially suitable process. To accelerate their clinical and commercial programs, companies are choosing to work with contract development and manufacturing organizations (CDMOs). In this article, we highlight key areas where CDMOs can help companies get started in the world of CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.

Thermo Fisher’s stepwise approach to Quality by Design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

Frost & Sullivan recently invited industry leaders with gene therapy experience to participate in a new thought leadership forum, our Virtual Think Tank. This forum brought together leading minds in this emerging field to discuss key challenges and other insights related to reducing the cost of goods (COGs) for gene therapy.

Frost & Sullivan recently invited industry leaders with viral vector experience in cell and gene therapy to participate in a new and unique thought leadership forum, our Virtual Think Tank (VTT) series. This forum brought together leading minds in this emerging field to discuss the current state of regulatory issues around viral vector manufacturing, key challenges, and other insights related to viral vectors.

Bioavailability challenges are among the toughest problems faced by today’s formulators. Most of the prospective drugs in pharmaceutical pipelines today have low solubility, which means the active therapeutic ingredients can’t be absorbed when patients take them orally. This paper gives an overview of obstacles to bioavailability and summarizes the Lonza technology selection process.

Some of the most important technologies available to formulators are those that enhance bioavailability, given the large percentage of low-solubility compounds in today’s pharmaceutical pipelines. Formulators have many choices in their toolkit when it comes to bioavailability enhancement, so the tough call becomes which one to use for a given compound. Lonza has developed a full complement of tools that accurately predict the performance of bioavailability-enhanced formulations.

Clinical trials are conducted according to a protocol, which is the master action plan for how the study will be conducted. Clinical trial protocol design can have a significant impact on the sourcing strategy for commercial drug products used as comparators. View the article to learn how proper planning, effective communication with specialized experts, and providing the appropriate level of detail in the clinical trial protocol can help avoid subsequent sourcing issues and can minimize the need for protocol amendments