Newsletter | October 9, 2024

10.09.24 -- Who Handles Maintenance At Your CDMO? You Should Know

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Strategic CMC Planning Through A Phase-Appropriate Quality Approach

How can you ensure to meet the goals of your drug development program without sacrificing the late-stage requirements? Implementing a phase-appropriate quality approach to CMC planning ensures that quality activities are aligned with specific risks and challenges of each phase. Watch this webinar to learn more on how to integrate quality, scalability, and sustainability considerations into each stage of the development cycle. Learn more.

FEATURED EDITORIAL

Who Handles Maintenance At Your CDMO? You Should Know

Computerized Maintenance Management Systems (CMMS); Integrated Facilities Management (IFM); Mechanical / Electrical Systems (M&E); and pest control (!) ... who handles maintenance at your CDMO? Here's what you should know from someone who has been doing it for decades.

Strategic API Sourcing: Offshoring Vs. Nearshoring For A Resilient Supply Chain

Generic drug manufacturers must carefully consider the decision to offshore or nearshore API sourcing. It's not only about managing costs but also about ensuring a stable and reliable supply.

The Shifting CDMO Landscape – Don't Lose Your Balance

Our panelists describe how the landscape of today’s CDMOs continues to “shift,” what that means, and how to select and form solid partnerships within the changes.

INDUSTRY INSIGHTS

Optimize Punch Ejection Height For Maximum Press Speed, Increased Yield

Accurately setting the lower punch ejection height in your tablet press is crucial to the ejection process. Explore how to avoid poorly positioning your punch.

Work With An In-Country Clinical Trial Depot For Efficiency And Compliance

If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.

Identify And Mitigate Absorption Risks With PBPK Modeling

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

Key Offerings To Help Support Your OSD On Its Journey To Market

Examine several important factors needed to effectively support oral solid dosage therapeutic manufacturing and overcome the complexities involved.

Seizing Market Share Pre-Patent Expiry: Navigating Paragraph IV ANDA

The dynamic pharmaceutical landscape demands agility and strategic foresight. Uncover how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.

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Join the next Outsourced Pharma Live as our panel explores the critical considerations and best practices for selecting and managing CDMOs in the development of novel therapies, including advanced therapy medicinal products like cell and gene therapies. Industry experts will share insights on evaluating CDMO capabilities, ensuring quality and compliance, and fostering effective partnerships to accelerate innovation while mitigating risks.

SOLUTIONS

Nitrosamine Capabilities

Pinpoint impurities and conduct confirmatory testing under cGMP with the help of an expert team utilizing cutting-edge mass spectrometry technology to boost your drug product development.

Pathways For Pulmonary Delivery

As orally inhaled drug delivery grows to encompass novel therapies and diverse molecule sizes, CDMOs are rising to meet the demand for specialized knowledge and scalable manufacturing capabilities.

A Versatile And Future-Proof Blister Packaging Machine

The BE3 Flex is a versatile, mid-speed blister packaging machine, designed for high-quality, tool-free format changeovers, accommodating diverse pharmaceutical applications with maximum efficiency.

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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