Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.
Single-use solutions continue to grow in popularity, largely as a result of the cost and time efficiencies they can afford biopharma companies.
As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
As cell and gene therapies become more prominent, industry is seeking the expertise and capabilities of outsourcing partners to ensure success.