ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• How To Find The Right Balance In Cell Therapy Manufacturing

  The choice between closed and open fill/finish for cell therapy drug products ultimately involves a careful balance between safety, accessibility, efficacy, and the type of cell type used.

• Overcome Common Pre-Filled Syringe Challenges Through Partnership

  The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.

• Streamline Early-Stage Development To Reach The Clinic Faster

  Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.

• A Practical Packaging Components Checklist For Emerging Biotechs

  A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

• Sample Sizes For Performance Testing Of Combination Products, Packaging

  When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

• Engineering Advances In Needle Geometry To Accommodate Viscous Biologics

  Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.

• Formulation Development From Preclinical To First-In-Human

  A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.

• Parenteral Packaging And Delivery Systems: Container Closure Integrity

  Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.

• An Insoluble Problem? Oral Drug Solubility With Functional Polymers

  Review the basics of solubility enhancement and the formulation and manufacture of products that enhance solubility and common questions on the topic.

• Formulation Research Strategy For Discovery- Stage New Drug Candidates

  Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.