Bedside preparations for conventional biopharmaceuticals (e.g. reconstituting the freeze-dried product) is so commonplace that regulators do not consider this part of the manufacturing process. So, drug manufacturers provide instructions for physicians or patients on how to prepare these drugs at the point of use. The Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. has similarly simplified the process for cell harvest, treatment, and proliferation, so that it could be performed by a process as accepted as bedside preparation of classical drugs. The new regulation will become effective on July 23, 2025. Read about it here.