Women In Bio Profile - Lessons Learned From 10 Years Performing Tech Transfers
Kelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.
WHITE PAPERS & CASE STUDIES
Procedural Reliability In Pharmaceutical Production
The worst thing that can happen on a pharmaceutical production line is a mix-up, i.e. either the product or the ID code is not what it should be.
High-Speed Pharmaceutical Glass Vial Inspection With In-Sight Vision Systems
Few industrial sectors have such stringent quality requirements as the pharmaceutical industry. To meet these exacting specifications, companies are increasingly utilizing intelligent vision systems.
Destructive Testing: Does Your Hard Tablet Measure Up?
Vitamins and medicines oftentimes come in the form of hard tablets. Manufacturers need to ensure that they hold together from time of manufacture to moment of consumption by the customer. R&D scientists have come up with a battery of tests that can evaluate the physical properties of tablets related to fracturability and crush worthiness. Instruments of choice called “Texture Analyzers” which have come initially from the food industry are being used to perform these tests.
Serialization And The Drug Quality & Security Act: A Top-Down Synergistic Approach
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to the global dilemma of safeguarding the public from the proliferation of counterfeit drugs, and the Drug Quality and Security Act (DQSA).
5 Questions To Ask Yourself Before Purchasing A Containment System
If you are considering purchasing one, here are five questions to answer that will help you prepare before contacting or working with a containment system vendor.
The Hidden Value Of Instrument Manufacturers
For those of you who work with any analytical/lab or process instruments, you know that staying in compliance with global regulations has become burdensome in the past decade. Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the work flow as soon as possible; but to do so you need to know everything there is to know about equipment and instrument qualification. In the overall pharmaceutical manufacturing process, you may be just one cog on the gear of productivity, but without some help, you could go from cog to clog very quickly. By Tara S. Hundley