INSIGHTS ON DRUG DEVELOPMENT

• Shortening The Timeline To First In Human (FIH) Clinical Dosage Form For Oral / Injectable Delivery

  Lengthy early development timelines are common across new & emerging biotech companies for a multitude of reasons. Striking the right balance of speed, quality, risk, and investment allows you to shorten timelines and work with efficiency. Strategies adopted for a rapid development of a simple yet flexible format proves beneficial.

• Quantification Of Vector Genomic DNA And Residual DNA In Gene Therapy Vectors Using ddPCR

  Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.

• Product Development For An Oral Solid Dosage Using Continuous Manufacturing

  A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.

• IDT Biologika Overview

  IDT Biologika provides contract development and manufacturing of live viral vaccines, gene and immune therapeutics, and fill/finish of biologics.

• Achieving Speed To Market Using The Optimal Program For Your Drug Candidate

  With a variety of gene to IND programs on the market, it is important you carefully assess which program matches your technical expectations as well as your risk adversity profile.

• How Intelligent Collaboration Transformed A Generic Into A Best-In-Class New Drug

  A pharmaceutical developer specializing in leveraging common compounds for new indications needed to transform a generic solid active pharmaceutical ingredient (API) into a commercial, sterile injectable approved by regulators. Read how collaboration and the drive to find a workable solution led to a successful drug development program.

• Making The Medicine Go Down: Specialized Oral Solids Delivery Technologies

  Most oral solid formulations are designed to release the drug immediately after swallowing for rapid absorption into the bloodstream. However, some products have been developed to release the drug in a specific way following ingestion and provide a “controlled-release” of the drug products. In this article, Sandra Conway, Technical Lead at Pfizer CentreOne discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.

• The Importance Of End-To-End Thinking During Drug Product Development

  Throughout a drug product development program it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.