04.16.24 -- Managing Supply Chain Risks Using Relational Risk Analysis

Listen as Olena Chervonenko, Associate Director Quality Management and Compliance at PharmaLex, provides deeper insights into technology transfer and essential factors for achieving success.

Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.

Learn why it is not possible to definitively categorize or certify wipes for a specific class of cleanroom environment.

Compare and contrast the different construction methods available for designing and constructing a cleanroom, including stick-built construction, modular panels, prefabricated modules, and more.

Here, we provide a lyophilization process overview that dives deeper into freeze-drying and reviews drying pressure, temperatures, cycle optimization, scale-up considerations, and storage.

Identifying a trusted supplier that can address the myriad of challenges that accompany development for AAV-based drugs is critical to securing an asset’s ultimate commercial success.

Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.

Three experts in cold chain management walk through the advantages of end-to-end platforms for bulk drug substance management.

Gain a better understanding of the criticality of buffer to the biomanufacturing process as well as the challenges inherent to handling the sheer amount that is needed almost continuously.

Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

Partnering with a CMO that has applied traceability, serialization, and aggregation standards across its operations promises business continuity and speed-to-market that translates to a competitive advantage.

Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.

Lean construction, as a buzzword, gets a lot of play in the cleanroom industry for good reason. It is an idea that got its start with Toyota in the 1950s to maximize efficiency and eliminate waste in production.

As on-body delivery systems (OBDSs) enable the shift to patient-centric treatment, manufacturers must optimize the device and therapy formulation to minimize the risks and increase adherence.

As demand for more precise, tailored CRO services grows, so does the emphasis drug developers place on their partners’ flexibility, agility, and enthusiasm for collaboration.

Experts share the necessary development and manufacturing considerations for a smooth tech transfer, explore these challenges in depth, and discuss the questions you should be asking your manufacturer.