INSIGHTS ON ENTERPRISE SOLUTIONS

• Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start

  As pharmaceutical industry faces pressure to bring new drugs to market more quickly and at minimal cost, pharmaceutical and biotechnology companies are increasingly outsourcing various parts of the drug development and manufacturing process. This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.

• What You Need To Know About Process Characterization And Validation For Biologic Processes

  Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.

• Sponsor Challenges When Outsourcing Sterile Injectables

  ISR asked outsourcers of sterile injectable drug product to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.

• How To Avoid Bag Breakages With Product Loss

  A global Contract Manufacturing Organization (CMO) produces different drug substances (BDS) of highly valuables mABs in batch sizes from 10l to 700l for clinical phases up to commercialized products. They were facing a challenge with single use bags with a high loss rate of 0,5% to 5% due to their sensitivity at sub-zero temperatures. Read how they set up a cold chain process and implemented robust technologies around the brittle single use bag and to consequentially reduce product loss.

• Validated Shipping Of Filled Labtainer Pro BioProcess Containers (BPCs)

  Wet shipping tests are performed to ensure that Thermo Scientific™ Labtainer™ Pro BioProcess Containers (BPCs) maintain  integrity, keeping contents contained and protected. During shipping, wave action within a fluid-filled BPC exerts stress on the film, which can lead to cyclic fatigue of the materials. A variety of shipping tests were conducted on the Labtainer Pro BPC product line, including vibration testing, compression testing, and drop testing. Following the completion of this testing, all chambers were integrity-tested for leaks.

• Labtainer Pro BPC Extractables Profile

  Single-use technology (SUT) products are beneficial in the manufacturing of vaccines and biologics. With the introduction of the Thermo Scientific™ Labtainer™ Pro BPC, Thermo Fisher Scientific offers a compilation of the standard BPC assemblies for use in conjunction with other bioprocessing products.

• Labtainer Pro BioProcess Container (BPC) Quality And Integrity Testing

  As single-use tech becomes more common in the drug and vaccine manufacturing space,  bioprocess containers must improve ease of use, increase flexibility, and assure quality without compromise.

• Strengthening Your Chromatography Resin Supply Chain By Increasing Transparency And Control

  This white paper explores key components of our chromatography resin supply chain program which help customers control their supply chains as they seek to ensure steady progress towards their next milestone and consistent availability of medicines for patients in need.