Business Process Outsourcing

PRODUCTS

  • With over 70 years of experience in glass production, Stevanato Group, through its historic Ompi brand, is currently the market leader in cartridge manufacturing.

  • AST aseptic filling products address the unique processing requirements to gently care for biologic products during the fill-finish process.

  • BIOSTAT STR® single-use bioreactors and the BIOBRAIN automation platform are engineered to allow you to rapidly adapt your biomanufacturing facility to address changing requirements by offering multiple configurations and convenient software upgrades. The generation 3 system is now available with native DeltaV™ and access to our best in class BioPAT® toolbox.

  • In your organization, there are constant challenges to streamline post-approval changes to meet market demand and prevent drug shortages. Critical to a streamlined process is robust process change management with targeted assessments giving you the desired outcome to reduce deviations, lower cost of quality, and enhance your regulatory strategy.

  • Our USP <1207> and ASTM (F-3287-17) recognized Mass Extraction Technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV-bags, pouches or glass vials. Larger defect and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications as well as for the use in production environment allowing stability control as well as automated 100 % testing (also in inline machines).

WHITE PAPERS AND CASE STUDIES

  • Doubling The Speed Of Cell Line Development In A Large Pharmaceutical Company

    We explore how the Cell Line Development group at Janssen R&D was able to reduce one of their development processes to a single step thanks to new technology. 

  • The Case Of The Elusive Protocol

    A client required a chart review to evaluate survivability of pediatric patients with a rare metabolic bone disorder. By trying different protocols and overcoming complex issues of informed consent that had to be resolved before the study was successfully completed, they were able to successfully deliver a final clinical study.

  • Cloning Cell Lines: A Comparison Of 3 Methods

    Limiting dilution cloning (LDC) has been the standard for generating clonal cell lines. This case study compares methods, using different cell lines, to determine which delivers the most viable clones.

  • eRegulatory: A Site's Perspective

    Coastal Pediatric Research (CPR) was well aware of the eRegulatory trend that was surfacing. Before CPR selected a platform, the team gave some thought to what they wanted an eRegulatory system to contain and/or provide. Learn more about the criteria for their selection and what solution met their criteria.

  • Closed Manufacturing System For Autologous Cell Therapy Production

    Complete manufacturing system delivered technology innovation, novel automation solutions, and substantial IP in the cell therapy manufacturing automation domain.

  • UW Carbone Cancer Center Gains Visibility Into Site Accrual

    Monitoring accrual is a key responsibility for a cancer center administrator. From answering questions for leadership to preparing for a grant submission, knowing the ins and outs of a site’s accrual metrics can ensure greater operational efficiencies center-wide. Read how UWCCC was able to enhance their data analytics and visualization capabilities helping them improve operational oversight, especially through greater visibility into site accrual metrics.

  • Virtual Study Yields High Compliance & Retention Rates

    Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.

  • Beyond The Paper Binder: Comprehensive Cancer Centers Of Nevada Adopts Remote Monitoring

    Explore how Comprehensive Cancer Centers of Nevada (CCCN) modernized its regulatory documentation practices to enable remote site monitoring and improve efficiencies.

  • Advanced AI Helps Water Treatment Plant Reduce Energy Costs By 15-20%

    A water treatment plant’s operations branch for a North American city is using Emagin AI by Innovyze to reduce the operational expenditure (OPEX) required to deliver high-quality drinking water to its approximately 150,000 residents.

  • Rapid Deployment Of Manufacturing Options: An Analysis Of Risks And Benefits

    Biomanufacturers seeking the best approach to rapid implementation of flexible manufacturing capacity take into account the benefits presented by different modular construction options. Here we analyze different approaches to building manufacturing capacity and assess the economic benefits of each approach.

  • Outsourcing Trusted-Weight Dry Powder Chemicals To Support Expansion

    The gene therapy division of a major pharmaceutical manufacturer was looking for ways to overcome capacity constraints due to the increased production demands for process liquids and buffers. Non-core manufacturing activities, including the weigh and dispense steps in the process liquid and buffer preparation, were identified as bottlenecks impacting the overall production schedule. The proposed solution would provide ready-to-hydrate, trustedweight dry powder chemicals. Read how the customer benefited from the procurement of larger lot sizes that were not capable of being handled within their facility, resulting in annual savings for raw materials and QC testing.

  • Choose A CDMO Partner That Integrates Market Intelligence For Aseptic Fill And Finish

    To offer customers both favorable outcomes and exceptional value, a CDMO must make the curation and integration of deep market intelligence a core part of its service offering. 

NEWS