INDUSTRY INSIGHTS

• Extractables, Leachables, And Risk: Ensuring Safety In Pharma Manufacturing

  This session is designed for teams developing new products, optimizing processes, or preparing regulatory submissions, and will provide practical tools for a better approach to E&L management.

• Overview Of FDA's Expedited Program For Serious Conditions

  Review more details on the FDA expedited review programs, the incentives for obtaining such designations, and the required information/data to better position your investigational product for success.

• Particles In High Concentration Biotherapeutics

  Examine advanced analytical solutions that detect, characterize, and mitigate particle formation in high-concentration biotherapeutics caused by protein aggregation and surfactant degradation.

• Best Practices For Regulatory Excellence In Clinical Research

  Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.

• Techniques For PEGylation Site Identification

  Examine how our innovative methods enable the precise identification of PEGylation sites, unlocking deeper insights into the structure, stability, and function of biotherapeutics.

• Accelerate FDA Approval With Fast Track Designation

  Learn how Fast Track Designation streamlines the FDA review process and offers faster approval for serious diseases or life-threatening conditions.

• Formulation Development For Therapeutic Oligonucleotides

  Discover how expert formulation and analytical support enable the development of stable, injectable oligonucleotide therapies across diverse delivery routes and molecule types.

• EMA Support For Rare Disease Therapies

  Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.

• The Role Of A Consulting Firm In The IND Process

  Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.

• Lyophilization To Enable Drug Products Containing Labile Molecules

  Develop lyophilized formulations to overcome stability challenges and significantly extend the shelf life of sensitive therapeutic products.

• Injection Site Reaction Screening Methodology

  Optimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.

• Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future

  See why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.

• Engineering The Future Of Lipsomal Drug Delivery

  Explore our full collection of case studies to discover how liposome technology is transforming drug delivery across a wide range of therapies.

• Advancing Drug Development With Optimized LC-MS/MS Bioanalysis

  Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.

• Advanced Methodology Of PLGA-Based Parenteral Formulations

  To enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.