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• 01Does Quay do testing on the drug product?

  Yes. We have strong analytical capabilities in-house, and we are currently expanding to have all testing done in-house. Quay takes full responsibility for all validation of tests done in-house.

• 02What type of Microbiome products do Quay handle?

  Single strain, consortia, GM bacteria phage, FMT

• 03Does Quay offer stability testing on the drug product?

  Yes, analytical testing is carried out in-house or 3rd party if required (i.e., micro testing). For ICH stability storage, samples are stored and shipped to Quay by a local company for non-ICH stability storage, and samples can be stored in-house.

• 04Does Quay carry out excipient development?

  Yes, it is a part of our physical characterisation approach along with robustness testing.

• 05Is Quay able to handle spore-formers/genetically modified organisms?

  Yes, we can handle organisms up to BSL 2. We have strict bio-containment procedures within our suites.

• 06How many INDs have Quay supported over the years?

  Dozens, Quay have been operating for 20 years and have supported varying sections and submissions for INDs.

• 07What strategy would Quay use for a batch size of ~2,000 to 4,000 capsules?

  We would manually fill that size batch.

• 08Does Quay have their own capsule configurations?

  A lot of clients already know what they would like, but we advise what is best. We have extensive experience with coating development.

• 09Does Quay supply capsules for development work?

  We can supply capsules for development work, but the client can buy them directly. If you require coated capsules, that development work will take place at Quay.

• 10Can you tell us more about Quay's facility in the US?

  We are planning to have development capabilities and GMP capabilities ~Q1 2022.

• 11Will clinical packaging capabilities be available in the US?

  Yes, we will be offering complete packaging capabilities like what we have here in the UK.

• 12Does Quay prefer to package [capsules] in blisters or pots?

  We offer both. We do not have a preference. It is the choice of the client.

• 13Can Quay pack under nitrogen?

  Yes, we can pack under anaerobic conditions if required.

• 14Can Quay manufacture medical food products?

  Yes, however, our manufacturing facilities are to GMP standard, which comes at a cost. We can offer engineering batch manufacturing which cuts documentation down.

• 15What timelines/delays in project start-up are expected at Quay?

  Once a technical agreement has been signed, work can start within two weeks, starting with the transfer of analytical strategy. We are not currently experiencing any delays in project start-up, and clients’ supply of DS is usually the rate-limiting step.