02.18.26 -- Not So Fast Into The Night: Your Outsourcing Needs A Pause

Targeted modalities are pushing the boundaries of technology and therapeutic effectiveness. Their potential to transform patient care depends on leveraging the right expertise, technologies, and partnerships.

Overcome challenges and complexities in ophthalmic drug development by partnering with an integrated CRO/CDMO provider with extensive regulatory knowledge and scientific expertise.

A recent project applied process improvement methodology to the process validation step that ultimately provided not only an optimized, robust process but also an economic advantage.

This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” examines the most common causes of timeline delays in outsourced small molecule development—such as tech transfer challenges, assay development gaps, lean SME resourcing, supply chain constraints, and quality events—and offers practical strategies like contractual detail, contingencies, on-site presence, schedule buffers, and understanding CDMO internal turnaround times.

Combining POWDOSE and Diffucaps enables precise, individualized solid oral dosing—improving drug delivery, patient compliance, and therapeutic outcomes in personalized medicine applications.

Choosing the right bioanalysis CRO is vital to avoid costly delays. Sponsors need evaluation strategies that prioritize proven quality, predictable timelines, and submission-ready data.

Begin your ADC manufacturing journey by finding a partner who can provide support through every phase of the conjugate life cycle, including process optimization, scale-up, and validation.

The development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

Adopting renewable feedstocks is crucial for green chemistry. Innovations using bio-renewable materials can drastically reduce waste, solvent use, and process steps, leading to major benefits.

Discover how early polymer selection drives formulation success, with case studies linking polymer choice to drug release and practical insights for developing robust CR products.

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

Our state-of-the-art laboratories, equipped with cutting-edge processes and analytical instrumentation, enable us to efficiently conduct route scouting, accelerate process development, and optimize reaction conditions for the scale-up of materials used in toxicology studies and cGMP clinical and commercial production.

Learn about UK-based Upperton Pharma Solutions and the many advantages of partnering with a CDMO, including their extensive expertise and capabilities across oral solids and specialized nasal and pulmonary formulations.

Mikart manufactures a range of blister pack solutions — including blister pack tablets, 2-piece hard- and softgel capsules, and more — as part of our commercial pharmaceutical packaging and clinical trial packaging services.