Drug product testing

Drug product testing

Our expert team can manage and coordinate all of your analytical and microbiological testing requirements. This allows you to keep your drug product in the hands of one reliable partner and accelerates the delivery of your batches.

Developing tailored testing strategies

Developing tailored testing strategies

To ensure the highest levels of quality are maintained, your product must be tested at several stages across the manufacturing process. Your testing strategy should be tailored to your input materials and manufacturing process. Testing, especially growth-based microbial testing, can take a number of weeks.

What we do

What we do

Symbiosis can support your development of a tailored analytical testing strategy for both manufacturing and stability. We can manage all of your analytical and microbial testing needs either internally or through our proven network of qualified CRO partners.

From the testing of raw materials, right through to in-process controls, final product release and stability – Symbiosis has you covered.

Our drug product testing capabilities

Our drug product testing capabilities

All testing is undertaken in accordance with the relevant regulatory and pharmacopeial guidelines.

Analytical testing capabilities

  • Method development
  • Validation and transfer
  • Release testing including HPLC, Karl Fischer, SDS PAGE and ELISA.

Microbial testing and validation across the manufacturing process, including finished product testing.

  • Sterility
  • Endotoxin
  • Bioburden

ICH stability testing

  • Photostability
  • Freeze-thaw stability
  • In-use stability testing

Want to understand more on developing an appropriate testing strategy for your manufacturing process?

Contact us to discuss how Symbiosis can help.

Fill-finish expertise in handling the most complex of products

We have extensive experience in taking precious, complex drug products from manufacture to QP release.