Newsletter | January 24, 2025

01.24.25 -- December 2024 — CDMO Opportunities And Threats Report

INDUSTRY INSIGHTS

Embracing AI In Digital Transformation: What You Need To Know

In the age of digital transformation, AI is no longer optional. Learn how to successfully integrate AI into your organization's operations for a competitive edge.

Lower Punch Tip Bending/Buckling

When manufacturing mini-tablets, adjusting punch force ratings is crucial to prevent bending or buckling. The Rankine-Gordon formula offers a safer force rating for microtip tooling.

Accelerated API Manufacturing: Combining All Process Development Stages

During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

Annex 1 Compliance Guidelines For Biological Indicator Users

Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.

Blow-Fill-Seal For Biologics: Breaking Through In Pharma Packaging

As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs.

Design, Operation, And Automation In Aseptic Filling Systems

Learn about a modular and compact filling and closing system for flexibility in pharmaceutical manufacturing operations and the automated processing of vials, syringes, and cartridges.

Stick-Pack Benefits For Pharmaceuticals And Nutraceuticals

Explore the key advantages of stick-pack formats for pharmaceuticals and nutraceuticals, from enhanced product safety and cost-efficiency to improved compliance and marketability.

De-Risk Through Early In Silico And In Vitro Assessments

Rebecca Michael, Ph.D. from Lonza Early Development Services answers attendee questions from a recent webinar about in silico and in vitro design and optimization tools.

Pharma Analysis And QC: Trends From The Rapid Pharma Evolution

Discover how the pharma analysis and quality control community envisions future trends and if the challenges faced by your peers are the same as yours.

The Role Of Training Devices And Education In Self-Injection Therapies

Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

Specializing In Small And Early-Stage Partners, Not Just Small Batches

Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

Understanding Computer Software Assurance (CSA)

The FDA recommends a new approach to computer system validation called Computer Software Assurance. Explore insights that can help you understand CSA and how to implement it in your organization.

Production And Clarification Of Lentiviral Vectors

Explore scalable processes for lentiviral vector production and clarification at the 50 L scale, utilizing the CTS LV-MAX system and single-use bioreactors for robust gene therapy manufacturing.

FEATURED EDITORIAL

December 2024 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

SOLUTIONS

Robotic Pharmaceutical Labeling Cell System: HERMA 211R HC

Factors Which Impact mAb Process Scale-Up

Polymer Processing Capabilities

SecurityLink HPLC/UHPLC Fingertight Fittings

Buffer Innovation In A Single-Use Package

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