INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides?

  Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.

• November 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.

• Leveraging Platform Processes For Developing And Accelerating Novel Gene And Cancer Therapeutics

  Explore how platform processes advance gene therapies, the impact of strong partnerships on patient access, and the future shaped by these collaborations.

• Phase IIb Trial Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer

  This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.

• The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations

  The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

• Enhancing Medical Information Services Through Contact Centers

  As the pharmaceutical industry in JAPAC region grows, the need for efficient MI services is surging, and offshore contact centers in India and the Philippines offer a cost-effective solution.

• Are We Witnessing A New "Age Of The CDMO"?

  Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. This article examines the driving factors and the author's perspective for what to expect in 2025 and beyond.

• Navigating The Future: For Each And Every Patient

  As a full-service CDMO and bio-logistics provider, we deliver end-to-end solutions across the entire value chain, supporting the production, distribution, and delivery of cutting-edge cell and gene therapies.

• Inspiring Waves Of Change

  Our comprehensive capabilities include the production of Active Pharmaceutical Ingredients (APIs), advanced intermediates, Cell and Gene Therapy technologies, registered starting materials, and analytical services.

• Building Clinical Quality Assurance

  Navigating the intricate clinical development process necessitates a robust Clinical & Development Quality Assurance Department to ensure adherence to health authority regulations.