Newsletter | June 12, 2025

06.12.25 -- Lean Thinking For Pharma — Flow Without Facility Upheaval

SPONSOR

Webinar: What Your Environmental Monitoring Isn’t Telling You

Discover the hidden risks your environmental monitoring (EM) might be missing in this Contec webinar. Learn how stable EM trends can create a false sense of security, overlooking issues like environmental residues, poor housekeeping, and inadequate operator training. Gain practical strategies to enhance contamination control, supported by real-world examples and expert insights, and receive checklists to improve cleanroom management immediately.

INDUSTRY INSIGHTS

Lessons Learned From Implementing The FDA's CSA Guidance

Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

Increasing Manufacturing Downstream Process Efficiencies

Downstream processing can account for up to 80% of biopharmaceutical production costs. Optimizing this stage is crucial for resource management, product quality, and overall yield.

Formulation And Evaluation Of Enteric Coated Aspirin Capsules

Enteric polymer coatings play a crucial role in oral drug formulations, protecting the API from harsh gastric conditions and enabling targeted drug delivery with optimized release based on location.

Understanding AI In Life Sciences Quality Assurance And Validation

Discover how AI is revolutionizing Pharma 5.0 with Daniel Tobin as he reveals practical strategies to enhance quality assurance, ensure compliance, and accelerate innovation in life sciences.

De-Risk Through Early In Silico And In Vitro Assessments

Rebecca Michael, Ph.D. from Lonza Early Development Services answers attendee questions from a recent webinar about in silico and in vitro design and optimization tools.

From Bottlenecks To Breakthroughs: Mastering Buffer Management

Traditional process liquid and buffer manufacturing has been shown to be resource-intensive. Watch to explore strategies to overcome buffer-related bottlenecks in large-scale biomanufacturing.

Overload Setting – Tricks And Techniques

Learn how a partner company that is committed to assisting manufacturers with calibration and optimal set-point establishment can serve as a valuable resource in achieving optimal tablet production.

4 Steps To Understanding The Quality Journey

Explore a four-step framework for organizations to enhance quality management, emphasizing its importance in driving business success, customer satisfaction, and competitive advantage.

Accelerating Technology Transfer Through Unified Recipe Management

See how a unified recipe authoring workflow can reduce technology transfer times in manufacturing, enhance validation efficiency, and streamline operations by integrating process control systems.

Forget Lean Cleanroom Construction, Practice Lean Installation

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.

Mobile Lab For A Large Pharma Client

Completed in 2021, find out how this custom BSL-3 mobile laboratory received PHAC approval and ensured a secure environment for PPD powder-related MTech development work.

Building More Resilient API Supply Chains

It is important to pursue a dualistic, longer-term supply strategy that embraces cost control and supply reliability/diversity to improve the integrity and resilience of international supply chains.

SPONSOR

The PDA Regulatory Conference 2025 Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle continues its 34-year tradition of delivering impactful content that supports the development and implementation of effective quality systems across the product lifecycle. This premier pharmaceutical CGMP conference on 08-10 September 2025 in Washington, DC will focus on strategies to manage manufacturing and quality risks while driving operational excellence and sustainable compliance. Register Now

FEATURED EDITORIAL

Lean Thinking For Pharma — Flow Without Facility Upheaval

Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

SOLUTIONS

Small Molecule Process R&D And Manufacturing

Technology To Overcome Absorption Hurdles And Solubility Limitations

Transform Your Chromatography Processes With An Innovative Approach

Single-Use Microbial Impactor On A Filling Line

The Key To HPAPI Manufacturing Success

Integrated Biotech Services: From Strain To Commercial Product

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