INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• 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.

• Unlocking The Full Potential Of Precision Medicine In Oncology

  Precision oncology promises a new standard of care where therapies are tailored to the molecular profile of a specific tumor. For the full potential of precision medicine to be realized, regulatory, technical, clinical, and economic frameworks will need to evolve to the nuances of these novel treatments.

• Media Development: The Approach From The North

  CCRM, located in the heart of Toronto's Discovery District, is specialized in cell and gene therapy offering technical and business support from concept to market.

• Quality System Overview For GMP Manufacturing

  When you think about cell and gene therapies (CGTs), what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases. Unfortunately, what is sometimes overlooked or left to the last minute is the less-than-glamourous, but still critical, manufacturing steps that ensure a new, potentially lifesaving treatment reaches patients in a safe and reliable form. Following is an overview of the mandatory quality systems and functions that are required within a standard GMP facility to comply with ICH Guidelines including Q7 and EU ATMP guidelines, Canadian GMP (C.002) and U.S. FDA, PHS Act section 351/361 and CFR 21 Parts 210/211 and Part 11 as they apply to cell and gene therapy. Other guidelines are considered, as required, such as ISO 9001:2015 certification.

• Five Steps To Ensure Your Cell And Gene Therapy Product Is GMP Compliant

  To prepare the product for in-human testing clinical protocols are developed in consultation with the regulatory authorities, a target patient population is identified, clinical investigators and an appropriate contract research organization are selected, and funds are obtained. What is sometimes overlooked, or left to the last minute, is the less-than-glamorous, but still critical, manufacturing steps that ensure a new, potentially life-saving treatment reaches patients in a safe and reliable form. In this post we will map the five critical steps that require thoughtful measured consideration for a CGT product to be produced in a good manufacturing practices (GMP) facility.

• Considerations For The Use Of Stable Producer Lines In The Manufacturing Of Lentiviral Vectors

  There are many challenges with transfection-based protocols for producing LVVs at large scale. Here we will take a closer look at the use of stable producer cell lines as an alternative to transient transfection for the manufacture of LVVs.

• How Can A Contract Development And Manufacturing Organization Advance A Cell & Gene Therapy Product?

  There is no one-size-fits-all answer for cell and gene therapy developers seeking to determine why, and more importantly when, to outsource manufacturing or process development to a CDMO. This blog covers the services and benefits of working with a CDMO to help you through the process.

• What Is The Best Way To Manufacture Lentiviral Vectors For Cell And Gene Therapies?

  In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and Lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by its end use. This blog outlines the challenges for optimization of scaled-up LV manufacturing processes and new technologies being used to solve these challenges.