Artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.
Once protein purification work surpasses a certain scale in terms of volume, a measured and step-wise development of the bioseparation process is vital.
Mixed-mode chromatography matrices are designed to present multiple interaction modes to resolve target proteins and impurities, entities that are themselves complex multimodal molecules.
Laboratory owners are constantly challenged to create new research environments with limited budgets and few resources. In addition, consideration has to be given to the “triple bottom line” (people, planet and profit), within these strict budgetary constraints. Cost-conscious owners want facilities to meet their vision and business objectives while also including flexibility, efficiency, safety, and robust utility/engineering systems.
Managing the integrity of manufacturing data is becoming ever more challenging, particularly as more and more critical manufacturing functions are outsourced, thus limiting the amount of oversight a pharmaceutical company can provide. Life science companies need to demonstrate control over their data—whether internally or externally generated. FDA officials indicate that “data that are not valid and trustworthy is a sign that an entire operation or facility is out of control and cannot assure the quality of its medicines”. Without accurate data, companies are less equipped to ensure the safety, effectiveness and quality of their products.
Unlike small molecule drugs, biologics are extremely sensitive, and therefore require specific handling procedures throughout the manufacturing process.
It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.
There are simple and straightforward chromatography maintenance tips involving sample preparation, buffers, columns and the overall system to keep your experiments humming along.
In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.
“Why do you need this laboratory information management system (LIMS)?” “We have an enterprise resource planning (ERP) system, why do we need to purchase yet another software product?” “How will the system you’re recommending improve lab operations?”
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