INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Essentials Of Auditing In The Manufacturing Of Cell And Gene Therapies

  Read useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect.

• Gene Therapies: Overcoming The Biggest Hurdles In Manufacturing

  The last decade saw a great rise in gene therapy popularity. Today, gene therapies have reached a momentum with hundreds in clinical development and several therapies approved in recent years. However, the rapid growth of the sector and the complexity of gene therapies has resulted in a number of challenges in process development, scale-up, manufacturing, and regulatory guidelines. See how a CMO can help you maset gene therapy manufacturing.

• BioReliance® Gene Therapy Services

  We are your partner for manufacturing and testing of viral gene therapies and gene-modified cell therapies. We offer manufacturing and biosafety testing for every stage of gene therapy development.

• Induced Pluripotent Stem Cells: Key Considerations For Reprogramming

  Ever since Yamanaka’s stunning discovery, the generation of pluripotent stem cells (iPSCs) from somatic cells has had a significant impact in disease modelling and heralding new developmental. The ability to reprogram cells has evolved into a powerful technique in just over a decade, with stunning discoveries in multiple clinical applications.

• Process Characterization: Ready For The FDA?

  Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.

• Cell & Gene’s 2020 Outlook: Supply Chain, Drug Pricing, Outsourcing, And More

  In the final segment of Cell & Gene’s 2020 Outlook series, you’ll hear from Natalie Holles, President & Chief Executive Officer of Audentes; Ryan Bartock, Head of Supply Chain and Network Strategy at Spark Therapeutics; Janet Lambert, CEO of Alliance for Regenerative Medicine (ARM); and Sophia Ononye-Onyia, PhD MPH MBA, Founder and CEO at The Sophia Consulting Firm. These industry luminaries and Cell & Gene Editorial Advisory Board members provide their insightful outlooks as it pertains to their role in the sector

• Induced Pluripotent Stem Cells In Cell And Gene Therapy – Part 1: Understanding Reprogramming

  Reprogramming iPSCs remains an open and manual process, carried out using conventional basic research techniques. To advance cell and gene therapy (CGT) and to get products derived from iPSCs to the clinic, generation and maintenance of cells for therapeutics in a Good Manufacturing Practices (GMP) setting becomes paramount. So, how is this achieved?

• 5 Reasons To Consider APAC For Clinical Trials

  Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies.Here are five reasons why the APAC region may be a good fit for your global clinical trial.

• Road To Success: Understanding Good Laboratory Practice For Cell And Gene Therapies

  Given the complexity, diversity and rapid change of technology and techniques for cell and gene therapy (CGT) products, such standardization is often difficult (but not impossible!) to achieve. With key considerations, GLP studies enable investigational new drug (IND) and clinical trial application (CTA) filings and human clinical trials.

• Outsourcing Trends For Cell & Gene Therapy

  The cell and gene therapy sector’s focus on outsourcing is a major area of on-going concern due to the shortage of suitable manufacturing facilities and qualified outsourcing staff.  This collection of original articles from Cell & Gene weighs the economic benefits of outsourcing (i.e. productivity, efficiency, time-to-market, and quality gains) as well as best practices for selecting an outsourcing partner. Here you’ll find information about the current limitations associated with a complicated manufacturing process as well as existing and promising opportunities and developments needed to outsource most — if not all components — of the value chain.