ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• A Smarter Strategy For Optimizing Oncology Drug Products

  John McDermott, VP of Scientific Consulting, shares insights on the benefits of evaluating targeted oncology molecules in healthy volunteers and applying an effective platform to accelerate drug product optimization.

• Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls

  Utilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.

• Unlocking New Possibilities For Treating Rare Genetic Diseases

  With over 7,000 rare diseases, the potential for nanomedicine to revolutionize treatment is immense. While polymer nanoparticles hold great promise, several challenges remain.

• Selecting An Alternative Coating Technology To Silicone Oil For Prefillable Syringes

  The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.

• Taking A Best Practice Approach To Contamination Control 

  Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

• Vials Vs. Cryobags For Cryopreservation Of Therapeutically Relevant T Cells

  Explore how COP 50 mL vials could serve as a basis for cell therapies and storage solution to help facilitate the manufacture and commercialization of cell products.

• How To Leverage Modeling And Simulation In The Candidate Development Stage

  Modeling and simulation provides another way to predict the clinical performance of a molecule, based on a robust and holistic approach, before investing the required time and money.

• Understanding Injectable Drug Container Closure Systems

  Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

• Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery

  Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.

• Aseptic Filling And Processing Considerations For Biosimilars

  One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.