INSIGHTS ON MANUFACTURING LOGISTICS
-
Design Verification Testing Of Combination Products
Developing a combination product and seeking a list of tests to complete design verification testing? Review the details for planning, design inputs, design outputs, and design verification.
-
Single-Use Technologies: Trends And Top Tips For Making The Switch
Single-use technologies are an integral and rapidly growing part of the bioprocessing manufacturing landscape. Take a look at trends in single-use, plus top tips for making the switch.
-
Optimizing End-To-End Contract Analytical Support For Cell And Gene Therapies
The development and production CGTs present unparalleled complexities. Learn how a partner with robust end-to-end services can help you overcome challenges at every step of the drug lifecycle.
-
Mitigating Nitrosamine Risks In Pharmaceuticals
Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.
-
A Practical Packaging Components Checklist For Emerging Biotechs6/20/2024
A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations in selection components for your injectable drug product.
-
Lifecycle Planning For Containment And Delivery Of Biologics Drug Products6/20/2024
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.
-
Understanding Injectable Drug Container Closure Systems6/20/2024
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.
-
Microbial Challenge In-Use Studies6/13/2024
Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.
-
Navigating Your Holistic Approach To CCI For Biologic Drug Products6/12/2024
Explore an overview of the regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.
MANUFACTURING LOGISTICS SOLUTIONS
-
Why take the risk of selecting individual components that may not work well together? The West Ready Pack™ containment system, with proven container closure integrity, provides risk mitigation, convenience, and small quantities.
-
Thaw individual volumes of drug substances up to 70 L using a plate-based freeze-thaw unit designed for studies and small-scale batches.
-
Used Wilco Model Wilcomat DKI-SPEZ leak testing station, with Dell Optiplex 7020 PC with 17" Monitor, keyboard and mouse, 220V, 1ph, 60Hz, serial# 1195346S.
-
Optimize single-use solutions for cryopreservation by engaging in studies that focus on specific timepoints and conditions pertaining to therapy storage, containment/protection, and transportation.
-
20L Flexsafe® bags are the most appropriate format and a cGMP manufacturing process using WFI-quality water ensure the highest level of quality for a product.