5 Commonly Overlooked Laboratory Checks for your FDA cGMP Audits

April 1, 2015 | Posted by Team in Outsourcing Trends |

This blog post is a guest post from Edword Simpson, technical engineer at Science Exchange lab, RS Calibration.

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Ensuring that everything in your laboratory is ready for any upcoming audit is a nail-biting task. The annual FDA audit for compliance with regulatory guidelines, like the current goods manufacturing process (cGMP) is especially tedious. Manufacturing processes and equipment for pharmaceuticals are regulated very carefully by the FDA and require strict adherence to industry standards.

 

Here are five things that aren’t always given the attention they require and could easily result in regulatory action for failing to comply with cGMP: Read the rest of this entry »

Small Biotech Stories: American CryoStem

October 29, 2013 | Posted by Brianne Villano in New Innovations |

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Some companies skirt regulations, opting instead to go off the radar. American CryoStem‘s Anthony Dudzinski‘s first words to me on the phone during our discussion were, “We follow the rules.” They’ve accumulated the greatest depth of adipose tissue-based cellular technology research relative to creating their laboratory and processes at a clinical cGMP level, and they’ve done it by actively engaging FDA consultants in the process.

Anthony F. Dudzinski, COO at American CryStem

Anthony F. Dudzinski, COO at American CryoStem

They’re looking at adipose-derived stem cells – also known as mesenchymal cells. ‘Mesenchymal’ was the original name of cells that came from bone marrow, and the two types are 98-99% identical, but there are some difference with the protein markers and capabilities of adipose vs. marrow cells.

Marrow cells are better for blood-borne diseases like lymphomas, whereas adipose-derived stem cells seems to be much more effective than marrow for structural issues. The concentration of adipose cells per gram of source material is actually 500-1000x greater than bone marrow from same patient. They have the ability to differentiate into a multitude of other cells including chondrocytes. This has incredible potential for how doctors treat sports injuries and aging issues.

Anthony set the stage for the importance of the research,”Most sports or age injuries are due to ligament or cartilage damage to the extent that most of them are bone on bone. So what if we could take Mrs. Smith who’s 55 and played tennis most of her life but can’t play anymore and doesn’t want to have knee replacement surgery. We can take cells out of the fat in her own body, attach them to a scaffold to induce chondrocytes, insert them into the meniscal cartilage area, and as time goes by with normal rehabilitation, her body regrows cartilage in her knees and her pain is gone.”

Anthony is excited about the implications for creating tissue for repairs, wound healing, burns, tendon injury, etc., all coming out of cells taken from adipose tissue. Read the rest of this entry »

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