INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• The Future Of Highly Potent API Manufacturing - Lonza Perspective

  Highly potent active pharmaceutical ingredients (HPAPIs) represent an increasing fraction of new compounds in pharmaceutical pipelines today. Flexible and phase-appropriate infrastructure is needed to bring the next innovative medicines based on these challenging compounds from concept to commercialization. Thispresentation describes Lonza's HPAPI "manufacturing 4.0" investments and the company's innovative capabilities.

• Telltale Signs You’re With The Wrong CDMO

  Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.

• Continuous Or Batch: Deciding On The Best Solution For Your Oral Solid Dose Product

  Gaining a better understanding of continuous manufacturing and its fitness for your OSD product could secure more control over the quality and safety of your product and, ultimately, the future of its success.

• Outsourcing Success Requires Constant Evolution

  Industry Standard Research explains how Life Science Leader’s CMO Leadership Awards and the corresponding market research data can be used by biopharma companies to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.

• 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.

• Custom APIs: Aligning Drug Strategy With Partnering Strategy

  Development of novel custom APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

• Providing Solutions At Fair Value: A Spray Drying Case Study

  Pharmaceutical companies need CDMO partners that provide solutions at fair value. This CMO has a long history of investing in new technologies with innovators to help their customers achieve their goals, and one recent example is the construction of a new Hastelloy spray-drying unit.