ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Gliding Towards De-Risked Combination Product Development

  Learn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.

• Meeting Annex 1: A Proactive Approach To Regulatory Compliance

  It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.

• Steps To Overcome Challenges Associated With Biologic Formulation Development

  Explore guidance on the challenges posed by biologics, including overcoming degradation, establishing a stress test process, and the value of lipid nanoparticles (LNPs) and polymeric nanoparticles (NPs).

• Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

  Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.

• Early Solid Form Screening To Guide Drug Development

  Conducting solid form screening early can help your team select and isolate the ideal lead polymorph to ensure manufacturability and stability while avoiding costs and hiccups down the road.

• The Role Of The Contract Manufacturer In Medical Device Development

  With a trusted contract manufacturing partner, pharma companies can ensure that their innovative therapies come to market efficiently without compromising the quality of the drug and its delivery system.

• NovaPure Stoppers - The Right Choice For Oncology Drugs

  Vial containment systems with NovaPure® elastomer stoppers offer substantial performance benefits with their enhanced dimension control, reduced particle levels, inspection of every stopper, and use of FluroTec® film. Explore the performance of the film and why NovaPure stoppers should be the choice for sensitive drug products.

• Reduce Costs And Improve Adherence For Self-Administration Of Biologics

  There is a growing trend toward wearable injectors for bolus delivery in order to help improve adherence and lower the costs of therapy. 

• Successful Industrialization Requires Solid Foundations

  Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.

• Solutions For Accelerated Pharmaceutical Development

  Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.