Articles, App Notes, Case Studies, & White Papers

  1. Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing 9/9/2022

    This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

  2. Overcoming Melt Processing Challenges 7/21/2023

    Discover how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.

  3. How To Ensure Correct Component Selection When Outsourcing To A CMO 3/22/2023

    A CMO-recommended lyophilization stopper was contributing to several operational inefficiencies, including sticking and interlocking of stoppers during filling operations. Requalification work was required to make a change.

  4. Opioid Reformulation Filed As A CMC Supplement In Less Than A Year 4/1/2019

    Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.

  5. Customized Release Through Dispersed Dosage Formats 6/13/2024

    Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.

  6. Leveraging Advanced Analytical Capabilities To De-Risk Drug Development

    Characterizing a molecule's identity enables efficient process development and regulatory compliance. To achieve this, sponsors must leverage advanced analytical techniques that illuminate structure and purity.

  7. Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway 1/24/2022

    Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

  8. Is It Ever Too Soon To Start Your Performance Testing Assessment?

    Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

  9. Gaps In Reconstitution Process Filled By Water-For-Injection Syringe

    The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.

  10. Enhancing Patient Adherence Through Autoinjector Access

    As autoinjectors evolve to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.