Tag: <span>contract manufacturing organization</span>

Facility Design for Contract Manufacturing

The number of mammalian cell-culture based products is increasing rapidly and has the potential to out-pace the current production capacity. New facility construction for mammalian cell culture production is costly and time consuming. Planning for initial product launch and long-term commercial manufacturing can be daunting for promising products in late phase clinical trials…

Read MoreFacility Design for Contract Manufacturing

Biologics Production

biologics production biopharmaceutical clinical trial materials cmo commercial manufacturing organzations contract manufacturing organization facility design mab mammalian cell culture monoclonal antibody single-use bioreactor

Protein Production from Mammalian Expression Systems for Research and Early Development at Contract Facilities — A Primer

In the late research/early development stage of a biologic, it is often necessary to produce a larger quantity of a protein than a company is capable of producing internally. At this stage, the availability of the purified protein may govern its continued development. The protein needs to be produced with a minimal amount of waste; i.e., with a minimal amount of personnel and expense, in the shortest amount of time possible…

Read MoreProtein Production from Mammalian Expression Systems for Research and Early Development at Contract Facilities — A Primer

Biologics Production

biologics production biopharmaceutical cell culture conditions cmo contract manufacturing organization expression levels protein expression purified protein scale-up

Contract Pharma Manufacturer Optimizes Quality Check Process With the Cubis Lab Balance

As a contract manufacturing organization (CMO) in this environment, it is essential for hameln pharma to deliver goods to their customers reliably, in terms of quantity, delivery time, and quality. Therefore, the topic of quality assurance plays a huge role— for both final packaged units as well as for bulk products. After a long-term analysis of the bulk product weighing process, hameln pharma’s objective was to significantly streamline the time-consuming process of manual counting and visual inspection. Moreover, taking cGMP standards into account, they wanted to optimize their existing process in order to remove any possibility of incomplete package volumes. Katrin Strasser, hameln pharma’s operational excellence expert, explained that: (1) packing box weights fluctuated with humidity levels during their manufacture; (2) labels for product packages varied; and (3) the actual number of items in a box carton were not always consistent

Read MoreContract Pharma Manufacturer Optimizes Quality Check Process With the Cubis Lab Balance

Biologics Production

biopharmaceuticals bulk weighing process cgmp cmo contract manufacturing organization lab balance

Continued Process Verification: Monitoring and Maintaining a State of Control

To ensure that a commercial biomanufacturing process is in a state of control, life science companies must create and successfully execute initiatives to meet continued process verification (CPV) and other monitoring guidelines. Management at pharmaceutical, biotech, and medical device companies commonly receive directives associated with data monitoring. Various challenges arise in the development and maintenance of a successful global monitoring program. Because of this, many companies develop data monitoring programs that are not scalable and sustainable. Company leaders struggle with how best to adopt, deploy, and scale monitoring systems to achieve defined quality monitoring goals. The purpose of this article is to display a maturity model to help companies navigate the major steps of implementing a global monitoring plan for continued process verification…

Read MoreContinued Process Verification: Monitoring and Maintaining a State of Control

Biologics Biologics Production Mammalian Cell Culture Manufacturing Process Automation

cmo continued process verification contract manufacturing organization cpv data monitoring FDA fda guidelines maturity model meta-monitoring