Biotechnology drug development process
Selection of an appropriate linker is important, and Goodwin Biotechnology demonstrates tremendous flexibility in this regard. We can:
Moreover, selection of an appropriate cytotoxic payload to which the target cancer cell demonstrates susceptibility is critical, and Goodwin Biotechnology will help to evaluate a payload of the appropriate potency and specificity under the Safebridge or Merck classification systems (e.g., protein toxin, cytotoxic peptide or small molecule cancer drug).
Goodwin Biotechnology can work with cytotoxic payloads up to Safebridge Level 3 within our own facilities (e.g., doxorubicin or methotrexate); however, for ADCs utilizing highly potent cytotoxic payloads (e.g., maytansine, auristatin, DM4, or tubulysin) requiring a Safebridge level 4 / Merck level 5 facility, GBI has collaborated with Coldstream Laboratories where we seamlessly execute all conjugation processes within Coldstream’s high-containment facilities, from proof-of-concept through late-stage clinical trials and large-scale cGMP manufacturing or commercial products.
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Starve, how about poisonby Worn_Out
"FDA believes it is very important for the public to understand how government is overseeing the new foods being introduced into the marketplace and to have confidence in that process. To that end the Agency appreciates this opportunity to describe its processes and procedures to the Committee and to the public, and to clarify what bioengineered food products are and how FDA regulates them.
For almost two decades FDA has been studying genetic modification techniques for drug-biologic development, as well as the development of new foods, and the Agency has carefully developed policies to accommodate the changing and evolving world of biotechnology
RIP- Eugene Goldwasserby dj_swearengen
Eugene Goldwasser 88, a largely unsung biochemist whose 20-year pursuit ofan elusive protein led to the development of a widely used drug that became one of the biggest products of the biotechnology industry, diedFriday at his home in Chicago.
In the late 1970s, Dr. Goldwasser, working at the University of Chicago, isolated and purified erythropoietin, or Epo, a protein that spurs thebody to produce red blood cells. He shared his precious material with a young biotechnology company, which figured out how to produce larger amounts of the protein using genetic engineering. That company, Amgen,became the world's biggest biotechnology company on the basis of Epo
Specification of Drug Substances and Products: Development and Validation of Analytical Methods
For Wisconsin companies, BIO 2014 is about making connections — BizTimes.com (Milwaukee)
For Catalent Pharma Solutions, a leading provider of biologics drug development and delivery that has a biomanufacturing center of excellence in Madison, BIO serves two main purposes: helping to build business relationship and providing company ..
PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design (Biotechnology and Bioprocessing)
Book (CRC Press)
Biosimulation in Biomedical Research, Health Care and Drug Development
Specification of Drug Substances and Products: Development and Validation of Analytical Methods (Progress in Pharmaceutical and Biomedical Analysis)
Pharmaceutical Dosage Forms and Drug Delivery, Second Edition (Pharmacy Education Series)
Book (CRC Press)