Newsletter | January 9, 2025

01.09.25 -- Survey Findings: How Are IDMP Readiness Efforts Progressing?

SPONSOR

We’re ready to help usher your next drug into market! 2025’s first Outsourced Pharma Capacity Update provides a unique, virtual experience and the details necessary to find a CDMO for your specific timeline, volume, and production needs. Join us the last week of January as we draw the curtains on the industry’s best and give you complimentary VIP access to the resources available to support your success. Learn more and register to save your seat!

FEATURED EDITORIAL

Survey Findings: How Are IDMP Readiness Efforts Progressing?

ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

Is Executive Leadership At Today's CDMOs Up To The Job?

A report from WittKieffer's Global Life Sciences provides a macro analysis of the executives that helm today’s CDMOs. When choosing a CDMO, are you adequately assessing their senior executives? Do they inspire confidence in being a well-governed and operated entity?

INDUSTRY INSIGHTS

Challenges Associated With In-Use Simulated Administration Of Biologics

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

Current Trends And Innovations In The Development Of ADCs

Learn the current innovations and trends in the development of ADCs focusing on three main aspects: linker technology, drug payloads, and manufacturing.

Can Glass Prefillable Syringes Withstand Deep Cold Storage?

Examine the impact of deep cold storage on functional performance, sub-visible particle levels, and container closure integrity in prefillable syringes.

How An Optimized Purification Platform Can Speed mAbs Clinical Production

Discover how a purification development platform with a mixed-mode chromatography step enabled Igyxos Biotherapeutics to streamline clinical trial supply and produce high-quality material efficiently.

Robust CHO Cell Expression Platform For High-Quality Biomanufacturing

Rapid development of high-quality cell lines is vital to biomanufacturing projects. How developers approach the fundamental steps can define their core biologics capabilities and keep projects on track.

Process Development For Lyophilized Products

Here, the authors explain how to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

Overcoming HCP Co-Elution Issues Using Cell Line Engineering

Product quality assessments revealed that a customer’s therapeutic protein had a range of hydrophobic HCPs. Review a solution that took an alternative approach by utilizing cell line engineering.

Adapting An Adherent hCK Cell Line To A Serum-Free Suspension RCB

This study develops a serum-free suspension MDCK cell line optimized for isolating human influenza viruses from clinical samples and scalable vaccine production.

SOLUTIONS

Capacity Update October 2024: Fill/Finish

In this video, we provide information about our new facility expansions, enhanced filling capacity, and advanced packaging capabilities designed to support and elevate drug development projects.

Your Innovation, Delivered With Certainty: Leveraging A Leading Global CMDO

We ensure that clients can tap into the knowledge and resources of Recipharm's experts worldwide, enabling them to navigate complex regulatory landscapes and penetrate new markets.

The Ultimate Guide To Clinical Supplies For Japan Studies

Utilize our Japan team's comprehensive services, including primary and secondary clinical packaging and labeling, comparator sourcing, cold chain storage, and local and global distribution.

Capacity Update October 2024: Fill/Finish

Our San Diego facility features a high-speed, multi-purpose fill-finish line for vials, syringes, and cartridges, capable of fulfilling your injectable manufacturing needs.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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