RECENT WEBINARS
Optimizing The Progression Of Biotherapeutic Candidates To FIH Studies
Learn actionable strategies that can lead to higher success rates and smarter resource investment, paving the way for a successful path to IND submissions and commercialization.
A New Look At Subcutaneous mAb Delivery Using Nanoformed Particles
A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the monoclonal antibody (mAb) impacts the overall behavior of the drug product.
How To Optimize Labeling In A Pharmaceutical Environment
Accurate, readable pharmaceutical labels are crucial. Learn to navigate considerations like printing, application tolerances, and inspection to select the right machinery for your production environment.
Accelerate And Enhance Biomanufacturing Operator Training
Unlock the power of blended operator training and learn how combining digital tools with hands-on instruction reduces errors, boosts retention, and empowers your workforce for real-world production success.
Navigating Regulatory Shifts: EU GMP Annex 1 And USP 382
Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.
Mastering The Complexities Of Gene Therapy Document Writing
Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.
Optimizing Biotherapeutic Protein Expression With CHO Vector Technology
Review the development of a high-strength synthetic gene promoter that enhances titers while maintaining exceptional product quality and expression stability, to support more efficient biomanufacturing.
Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation
The following insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.
Digital Transformation In Contract Manufacturing: A Leadership Perspective
Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.
PUPSIT Without The Pain: Practical Solutions For Implementation
Explore the critical role of pre-use post-sterilization integrity testing in quality risk management, as well as learn about integrity testing, wetting procedures, and innovative filtration systems for effective implementation.
CLD To Upstream Optimization: Enhancing Biologics Quality, Productivity
Explore how advanced cell line development and upstream processing strategies optimize both productivity and therapeutic effectiveness, ensuring the development of high-quality biologics.
3D Screen Printing: Breakthrough Solutions For Patient-Centric Therapies
Explore 3D screen printing’s potential to revolutionize pharmaceutical manufacturing with scalable, customizable, multi-drug tablets and precise, patient-centric drug release profiles.
Harnessing Potential: Innovations And Improvements In Viral Gene Therapy
Review the potential of AAV-mediated gene therapy as a platform approach to treat multiple genetic neurological diseases, and explore suggestions to streamline translational studies and reduce costs.
Transforming Rare Disease Drug Development For A Faster Cure
This comprehensive exploration aims to shed light on the critical aspects of expediting curative therapies, with a focus on the strategic role that CDMOs can play in this transformative journey.
Optimize Your Process For Producing High-Concentration Drugs
Explore the challenges and solutions in high-concentration monoclonal antibody manufacturing, which includes practical strategies for maximizing product recovery and optimizing processes for efficient production.
Optimal Tech For Predicting Drug Responses At The Cellular Level
Explore how preserving spatial molecular information and leveraging AI-driven spatial-omics can transform treatment prediction, patient stratification, and personalized medicine.
Minimizing Risk In RNA-LNP Encapsulation And Drug Product Manufacturing
Learn about an integrated drug substance/drug product offering for your IND program and beyond, with a holistic approach to ensure process robustness at every stage.
Shifting Drug Development With Advanced Analytical Characterization
Explore the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.
Who's In Charge? How To Ensure Effective Trial Oversight, Leadership
Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.
Rapid Delivery Of Toxicological Study Material: Accelerating Development
Explore key strategies and technologies designed to address the analytical considerations and material flows to facilitate the rapid delivery of toxicological material.
How High Drug Load Nanocrystalline Tablets Lower Pill Burden
We showcase the development of high drug load nanocrystal based tablets and prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the overall pill burden.
Human Factors Testing: Engaging End-Users In Med Device Development
Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.
Get $mart: 1 Year Out From Phase 1 Injectable Trials, Avoid 3 Expensive Mistakes
Learn how to scale up injectable drug production for Phase 1 trials, avoid costly mistakes, and find the right CDMO partner for long-term success.
Bioprocess Optimization: Leveraging Functional DOE With Time-Based Insights
Explore the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.
Discovery Through Commercialization: A Biologic Drug's Analytical Journey
Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.
From Research To Reality: Overcoming CMC Challenges In Cell & Gene Therapy
Explore the importance of adopting a Quality by Design (QbD) approach in the development process while integrating regulatory and CMC strategies for maximum efficiency and benefit.
De-Risking Early Phase Micronization With Integrated Solid Form Selection
Review a case study describing the selection of the optimal solid form of an API designed for pulmonary administration through the pulmonary route.
Contract Manufacturing: Must-Know Trends And Strategies For 2025
Regulated industries face rising demand, tech breakthroughs, and regulatory harmonization. Discover how contract manufacturers must leverage AI and cloud solutions to stay agile and compliant in the future.
Essential Considerations For Selecting The Right Biologic Fill/Finish Partner
Partnering with a provider that prioritizes quality and yield optimization not only ensures product safety but also helps reduce operational costs.
CMC And Clinical Strategies For Developing Injectable, Oral Peptide Drugs
In this session, Chief Scientific Officer Dr. Andy Lewis delves into the key drivers shaping peptide drug development and explores innovative delivery options to enhance therapeutic outcomes.