Newsletter | June 17, 2025

06.17.25 -- Getting To The Heart Of CDMO Tech Transfer Excellence

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Don't miss the next Bio-Expo Live! This interactive, multi-day event is organized by stages of drug development and production, making it easy to find sessions tailored to your company's needs. Browse the full agenda and register for free to join the conversations most relevant to your work.

FOCUS ON OUTSOURCING

May 2025 — CDMO Opportunities And Threats Report

By Outsourced Pharma

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.

Getting To The Heart Of CDMO Tech Transfer Excellence

Article | Bora Pharmaceuticals

Discover five key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to CDMO success.

Mitigating Oxygen Heterogeneity In Large-Scale Bioreactors

Article | By Jinhyoung Lee, Samsung Biologics

Oxygen heterogeneity, caused by pressure variations and other factors in large-scale bioreactors, can significantly impact cell growth and product yield.

The Benefits Of Incorporating Lean Methodologies Into Project Management

White Paper | By Patrick Hayes, CAI

Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.

SMARTag Technology, From Bertozzi Lab To Best-In-Class ADCs

Webinar | Catalent

Hear experts discuss the latest trends in antibody-drug conjugate (ADC) discovery and development and how next-generation pipelines are being shaped by payload and linker-chemistry innovations.

Best Tech Transfer Practices To Optimize Clinical And Commercial Supply

Webinar | Lonza

Facing challenges transferring your biological product from development to manufacturing? Delve into strategies for tech transfer processes, ensuring regulatory compliance, quality, and consistency.

Partnering For Scalable Suspension Processes Tailored To AAV Therapies

Article | By Samir Acharya, Andelyn Biosciences

Achieving optimized, scalable suspension processes for adeno-associated virus (AAV)-based therapeutics comes with a number of technical and business challenges.

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The PDA Regulatory Conference 2025 Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle continues its 34-year tradition of delivering impactful content that supports the development and implementation of effective quality systems across the product lifecycle. This premier pharmaceutical CGMP conference on 08-10 September 2025 in Washington, DC will focus on strategies to manage manufacturing and quality risks while driving operational excellence and sustainable compliance.

OUTSOURCING SOLUTIONS

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Capacity Update July 2024: Large Molecule Development - Aton Biotech

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Capacity Update April 2025: Large Molecule Development - Northway Biotech

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Capacity Update April 2025: Large Molecule Development - Boehringer Ingelheim Biopharmaceuticals GmbH

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