Articles

  1. Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage 3/24/2023

    Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

  2. Containment Solutions To Help Emerging Biologic Companies 3/24/2023

    Set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.

  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. A Risk-Based Approach To Injectable Combination Product Development 3/14/2023

    Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

  5. Collaborating With A CMO To Bring Your Sterile Injectable Product To Market 2/15/2023

    Review considerations for collaborating with a fill/finish CMO, including CMO selection, Request for Proposal (RFP) delivery, proposal review, and project award.

  6. Jayna Blake, Manager, Business Development 2/15/2023

    Jayna provides her perspective on the key considerations when outsourcing an injectable project to a CDMO.

  7. Bag Flling Is Now Possible In The United States 2/10/2023

    Explore the reasons why one CDMO is expanding its operations to offer flexible bag filling, after being equipped with filling lines for PFS and glass vials (glass or plastic).

  8. A Lifecycle Management Strategy For Sterile Injectables 12/9/2022

    Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.

  9. The Dynamic Regulatory Environment Of Drug-Device Combination Products 11/29/2022

    Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.

  10. Spray Drying For Improved Solubility 11/15/2022

    Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.