SMALL MOLECULE OUTSOURCING
How To Safely Handle Your Antibody Drug Conjugate
Internal specialized occupational toxicology and industrial hygiene knowledge can help solve the mystery of safe handling ADCs.
Scaling Up A Revolutionary Amorphous Solid Dispersion Platform
Process parameter and quality attribute relationships, including those for typical pre- and post-ASD unit operations, will be explored in the context of real-world examples.
Formulating Better ASDs And mAbs: Advances In Applied Nanotechnology
Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.
Understanding FDA Calibration Requirements And Best Practices For Reducing Risks
Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.
Considerations For Complex Formulations: How To Simplify Your Outsourcing
Experts share the necessary development and manufacturing considerations for a smooth tech transfer, exploring these challenges in depth, and discuss the questions you should be asking your manufacturer.
Combination Products: Navigating Regulatory Strategy, Design Verification
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
Rapid Developability Assessment Of Early Phase Molecules
A case study illustrating how to use PBPK modeling, the developability classification system, and the biopharmaceutics drug distribution classification system to facilitate development of a molecule.
Simultaneous Spray Drying: Dry Powder Inhaler Combination Formulations
The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.
Formulation Of Crystalline Nanoparticles Enabling Superior Drug Load
Explore how bioavailability of poorly soluble APIs can be improved and patient compliance enhanced by reducing the size or number of tablets that a patient must take to achieve the required dose.
Challenges With Pediatric Flavors For Taste Enhancement And Modulation
Taste masking for children can present unique challenges for drug developers. Learn how we can use flavor, not just to provide a desired taste, but also to provide taste masking.
Understanding Nitrosamines: Key Regulations And Best Practices
Gain expert insights into nitrosamine regulations and discover practical strategies for ensuring compliance and safeguarding product safety.
Discovering A Unique Multimillion Euro Nanotechnology Facility
Dr. David Rowe, Head of Manufacturing at Nanoform, provides an overview of Nanoform's manufacturing capabilities and introduces a new, state-of-the-art nanotechnology facility.
Improving Bioavailability, Drug Loads, And Pill Burdens Of Solid Dispersions
Explore the pros and cons of marketed amorphous solid dispersions with so-far unpublished data as well as a green alternative to ASDs: best-in-class nanotechnology to manufacture nanocrystals.
Taste Masking 101: Sensory And Performance Evaluation
Learn how techniques and innovations in taste masking sensory and performance evaluation can help accelerate your formulation development and confirm desired taste profile.
The Future Of Oral Solid Dose Development And Innovation
Tom Sellig, CEO of Adare, discusses the ongoing relevance of small molecules, oral solid dose development, trends like GLP-1, and innovations like 3D printing in pharmaceuticals.
OPTIMA 7000 Fill Line
Ajinomoto Bio-Pharma Services is a leader in aseptic filling, offering a wide range of capabilities for vials with our OPTIMA 7000 fill line. The OPTIMA VFVM 7000 safely processes various types and classes of biopharmaceutical products in 2 mL to 100 mL sizes.
Cambrex Scientist Spotlight: Myoung Goo Kim
Myoung Goo Kim, Chemistry R&D Manager in High Point, NC, is a recognized expert in process chemistry, specializing in API manufacturing for Cambrex’s clients.
Cambrex Scientist Spotlight: Elena Bejan
Holding a Ph.D. in organic chemistry from Paris-Sud University and an MBA from the Rotman School of Management, Bejan leads R&D efforts at Cambrex with a focus on scientific innovation.
How Can Nanoparticle Engineering Make The Difference For Alzheimer's?
Commercial Insights Officer Jamie Unwin discusses the power of innovative nanoparticle engineering technology and AI-based digital twin.
The Paradigm Shift To Continuous Flow Processes: A Holistic View
A clear increase in continuous flow processes has emerged over the past decade, thanks to the commercialization of preparative flow reactor units.
Environmental Sustainability: Wastewater Incineration Reduction
Discover an approach to wastewater treatment that reduces the environmental impact of small molecules production and introduces advanced treatment methodologies to avoid wastewater incineration.
Dramatic Reduction Of Solvent Usage In Pharmaceutical Spray Drying
Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).
Nanoscale Technology's Potential: A Fireside Chat With Industry Leaders
Nanoform CEO Edward Haeggstrom and Shawn Davies, head of drug delivery, biopharmaceuticals development, AstraZeneca, discuss the potential of nanoscale medicines and delivery devices.
Accelerating Clinical Development: Modern Tools In Process Chemistry
Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.
Expanding The OSD Toolbox
This session is designed to provide practical solutions for enhancing bioavailability and scalability in pharmaceutical formulations.
Cambrex Scientist Spotlight: Kelly McGuill
McGuill is dedicated to inspiring the next generation of scientists. Her commitment to quality ensures that clients stay compliant and focused on advancing to the next phase of their projects.
How To Design An HPAPI Plant And Its Containment Systems
Dr. Friederike Hermann, head of occupational hygiene and biosafety, shares her expertise on requirements and evaluating the right containment that meets the needs of all process steps and stakeholders.
Improve The Bioavailability Of Poorly Soluble Drugs
KinetiSol is a fusion-based, solvent-free process that utilizes frictional and shear energies — in a fraction of the time of other amorphous solid dispersion technologies.
Cambrex Scientist Spotlight: Daniel Kirschner
With a Ph.D. in bioanalytical chemistry from the University of Alaska Fairbanks, Kirschner brings nearly 15 years of experience in pharmaceutical development across biotech and CDMO sectors.
Innovative Technology For Developing, Scaling Peptide-Based Therapeutics
Watch as experts walk through several technologies and case studies, focusing on liquid-phase peptide synthesis, crystallization, method development for impurity analysis, and more.
Cambrex Scientist Spotlight: Jonas Nilsson
Jonas Nilsson, Principal Scientist based in Karlskoga, Sweden, leads a team of synthetic chemists focused on process development and optimization.
Nanoparticle Enabled Formulation And Drug Delivery Solutions
Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.
Patient- And Planet-Centric Bioavailability And Sustained Delivery
By reducing the size of drug particles, nanoforming offers new opportunities — from increased bioavailability to sustained drug delivery. Discover the potential benefits supported by case studies.
Rapid, Material-Sparing Feasibility Screening For Hot Melt Extrusion
Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.
Cambrex Scientist Spotlight: Luigi Bellone
Luigi Bellone, Head of Quality Assurance in Paullo, Milan, brings over 20 years of experience in quality assurance (QA), quality control (QC), and regulatory compliance within the pharmaceutical industry.
HPAPI Drug Product Development And Manufacturing Using Micronization Technology
Learn how to classify HPAPIs in early development and recommendations for safe product handling, from clinical manufacturing to commercialization.