Newsletter | August 4, 2022

08.04.22 -- 3-Step Strategy For A Successful Drug Candidate

New Podcast Episode
Featured Editorial
Industry Insights
Writing And Enforcing GxP SOPs For Compliance

For fiscal year 2020, the most common FDA inspectional observations for biologics, devices, and drugs involved SOPs. To avoid a warning letter from the FDA, life sciences companies need a methodical approach to their SOPs.

The Evolution Of Single-Use Systems And The Emergence Of Unmet Needs

The bioprocess boom of 2020, which continues unabated, has attracted many players into this space. More and more integrators are entering the market, one that's far from easy to master.

A New Mindset For Combination Product Development

As we balance the time-to-market and risk for novel therapies, we must anticipate changing needs for combination device development, highlighting the technological paradigm shift.

How Collaborative Value Engineering And Continuous Improvement Enhance The CDMO Relationship

Regular assessments of a partnership’s value in terms of supply chain, operational efficiency, data analysis, and more can optimize and extend the product life cycle.

8 Misconceptions On Collaborating To Benefit Your Drug Program

Review a few misconceptions about collaborating with Pfizer CentreOne and how they align with the values – courage, excellence, equity, and joy.

Analytical Considerations For Biopharmas During Commercialization

As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

A Review Of Ethylene Vinyl Acetate Copolymers In Transdermal Drug Delivery
Transdermal drug delivery (TDD) can offer constant drug levels, reduced dose frequency, and a noninvasive procedure that can be self-administrated. See how this technology has been driving the development of new drugs.
Proper Biological Indicator Placement During Vaporized Hydrogen Peroxide Decontamination Cycles

We discuss the three general BI types used for monitoring the VH2O2 cycles and directions on their proper placement in the isolator.

Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy

Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

Clinical Supply Optimization: Process Improvement Accelerates Clinical Trial Deliverables And Execution

A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.

Harnessing Targeted Protein Degradation

A leading biotech company working in the targeted protein degradation space was looking for fast delivery of the compounds, open, transparent, and on-time communication, and flexibility and ability to scale.

Addressing And Adapting To Evolving mRNA Market Trends

Pierre Catignol and Huisub Lim share their insights on current mRNA market trends, manufacturability, choosing an appropriate CDMO partner, and mRNA technology considerations.

Mixing Cannabis-Infused Products

Gain insights from a pharmaceutical equipment manufacturer on factors cannabis manufacturers should consider when they're looking to purchase a mixer.

Tips For Working Safely In The Laboratory With Your Biosafety Cabinet

Good technique when working within a Class II biosafety cabinet (BSC) will minimize air turbulence and prevent splatter or unwanted spread of aerosols.

Find The Right Intensification Strategy For Upstream, Downstream Processes

How do you know if an intensification approach will provide advantages? Three process intensification experts show how different intensification approaches affect outputs using different scenarios.

Chromatography, Purification, And Isolation Technologies

Explore options for the field of chromatography and allied downstream technologies and how these technologies are applied to design favorable processes in order to generate true customer benefit.

Delivering Process Robustness And Scalability In The New DynaDrive Single-Use Bioreactors (S.U.B.s)

Learn more about understanding the process robustness and vessel capability’s role in a seamless system transfer and S.U.B. process comparability.

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