Newsletter | September 5, 2025

09.05.25 -- Late-Stage Formulation Is A Different Ballgame

SPONSOR

Webinar: Liquid Phase Peptide Synthesis: Regulatory, Analytical & QC Perspectives

Discover how Cambrex is advancing peptide manufacturing with innovative liquid phase peptide synthesis (LPPS) technology, reducing costs, environmental impact, and reliance on specialized reactors. Join experts Adrian Amador and David Wang for this live webinar exploring LPPS applications, regulatory considerations, impurity control, and analytical strategies. Register today to gain insights that can accelerate your peptide development programs. Click here to learn more.

INDUSTRY INSIGHTS

Human Skin Explant Model For The Investigation Of Topical Therapeutics

Learn more about an ex vivo cultured human skin explant model in which pathological tissue integrity, barrier function, and metabolic stability have been characterized over time.

Sustainability By Design In API Manufacturing

Explore the urgent need for sustainability in small molecule API manufacturing, as well as reveal regulatory drivers, green chemistry innovations, and practical strategies to reduce emissions.

From IND To NDA: The Role Of The Kilo Lab In A Seamless Scaleup

To derisk your manufacturing, work with an outsourcing partner that prioritizes the kilo lab as a space to develop a proven, robust, and reliable workflow from clinical to commercial scale.

FEATURED EDITORIAL

Late-Stage Formulation Is A Different Ballgame. Insights From An Allstar

The art and science of late-stage/commercial formulation, compared to early-phase formulation, is a different ballgame, says Dileep Boinipally, currently utilizing CDMOs to advance a pipeline of oral and injectable candidates. He has a stadium full of advice for readers.

Audit Trail Compliance And What To Look For In Mitigation Software

In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

INDUSTRY INSIGHTS CONTINUED

Modifying The Micro-Environment To Improve Dissolution Rate

Discover how modifying the micro-environment with targeted excipients can significantly enhance the dissolution rate of poorly soluble drugs using conventional manufacturing methods.

Nitrosamine Analysis: Solutions For Risk Management And Analytical Testing

Testing for nitrosamines is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.

Considerations When Outsourcing Your Packaging Operations

Explore the key to maintaining and enhancing existing and new partnerships as well as how outsourcing one crucial aspect of bringing products to market can benefit overall supply chain optimization.

In Vivo Testing Of Nasal Dosage Forms

Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.

Formulation Strategies For Enabling "Undevelopable" Compounds

Pursue the optimization of target binders without sacrificing binding efficiency and specificity for improved drug-like characteristics. Empower the development of the most effective drug candidates.

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Explore 20+ new CDMO presenters in quick 20-minute sessions during Outsourced Pharma’s October Partner Week. Sessions include Analytical Services, ADC, Large and Small Molecules, Cell and Gene Therapy, and Fill/Finish. Each session offers a quick, informative look at capabilities to help you find the best-fit partner. Registration, on-demand access, and interactive Q&A are all free.

SOLUTIONS

Solve Complex Small Molecule Challenges

We specialize in the custom development and manufacturing of small molecule APIs, intermediates, and RSMs, offering scalable solutions from kilograms to multi-ton quantities.

Top Contract Drug Development And Manufacturing Company

From formulation to commercial scale, our pharmaceutical manufacturing (CDMO) team provides tailored solutions for each phase of your drug development program.

Amorphous Solid Dispersions: Pre-Clinical To Commercial Capabilities

ASDs are an attractive option for commercializing poorly soluble compounds. This talk focuses on capabilities to screen the potential for ASDs in early phase studies and their commercial applicability.

Analytical Method Development And Validation

Our scientists specialize in formulating dissolution media with the ability to sensitively differentiate the release profiles of various drug formulations under biorelevant conditions.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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