INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Benefits Of 5KL Bioreactor When Outsourcing Late-Phase Biologics Drug Substance Manufacturing

  Watch this webinar today to discover how Thermo Fisher Scientific is addressing and overcoming two critical, current challenges in upstream bioprocessing.

• Plasmid DNA

  Aldevron is a responsive and reliable resource of plasmid DNA for research, pre-clinical and commercial use. 

• Small Pharma, Big Opportunity: 8 Reasons To Look Beyond Size

  Should CDMO partner size influence selection for your large molecule project? To choose the best CDMO for you, here are a few reminders to help you look beyond size.

• Five Tips To Help Maximize Your Cell And Gene Therapy Budget

  Developing cell and gene therapies (CGTs), from discovery to commercialization, is highly complex. This can make it difficult to forecast budgets for development and manufacturing. Here are five tips to help maximize the value of your chemistry, manufacturing and controls (CMC) budget and stay on track to meet development milestones.

• Pharmaceutical Program & Project Management Services

  Our PPM team has significant experience in assisting owners with the development of clean, compliant facilities and processes for companies around the globe. We have the proven ability to develop the design concept, the construction plan/components, and procurement strategy. This ability coupled with a deep understanding of financial analytics required to make projects a reality help us to produce successful projects for our clients. Many of our PPM team members have previously sat in the end-user chair and now are able to assist other firms, like yourself.

• Pharmaceutical Commissioning & Qualification Services

  We set the industry standard when it comes to commissioning and qualification project delivery.

• Pharmaceutical Process & Manufacturing Technology Services

  In your organization, there are constant challenges to streamline post-approval changes to meet market demand and prevent drug shortages. Critical to a streamlined process is robust process change management with targeted assessments giving you the desired outcome to reduce deviations, lower cost of quality, and enhance your regulatory strategy.

• Cell And Gene Therapies Require Highly Specialized Formulation And Manufacturing Capabilities

  Recent improvements in our understanding of the human genome, together with advanced DNA editing and analytical tools, position the cell and gene therapy market for explosive growth. However, these technologies have significant formulation development, cGMP manufacturing and aseptic filling challenges. The engagement of a CDMO partner with a broad portfolio of delivery technologies, a strong formulation track record and manufacturing flexibility is the preferred pathway for success.

• 4 Tips From The Experts: How To Tighten Your Timeline From Development To Trial

  Responsibly moving a cell or gene therapy forward as quickly as possible is a challenge associated with navigating a project’s development pipeline. Here are some general tips to assist you as your project moves from development to trial.

• Outsourcing A Microbial Fermentation Project To A CMO Partner

  This interview with Dr. Lars Geiger, Director of Global Projects at Evonik, reviews key trends and scale-up challenges to manufacture a substance via fermentation.