Though the timelines may vary, across the globe more and more countries are requiring product identifiers and serialization of prescription drugs — right down to individual salable units. As global guidelines take full effect, it is worth understanding how contract manufacturing organizations are preparing themselves to comply to meet the needs of their customers.
Whether your goal is to increase patient compliance, improve clinical outcomes, or to extend a product’s lifecycle, modified-release dosage forms present a solution to myriad challenges. The trick is to understand the influence of both drug property and delivery technology on drug design, and to give you enough time to select and introduce the ideal release form for both therapeutic and economic advantage.
While some are waiting for mandates for traceability, serialization, and aggregation, others are recognizing the inevitability of these strategies. Does your CMO have a dedicated traceability operation within the company and serialization efforts in place?
Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and contract manufacturing organizations (CMO) carefully select equipment, outline processes and deploy appropriate containment strategies. Read how partnering with a knowledgeable and experienced CMO for this important stage of a drug’s life cycle can reduces costs and timelines, and ensures the safety of employees, the environment and the patient.
Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.
Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products.
Differentiating one’s CDMO offering from competitors is an essential component of gaining awareness, familiarity, and being awarded business. When CDMOs understand what motivates drug innovators to outsource, who is involved in the service provider selection decision, and which CDMO attributes have the greatest influence on CDMO selection they are able to communicate what is unique about their offering to the right audience at the right time.
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.
Hear how an adaptive and evolving platform of proven and novel technologies enables biomanufacturers to successfully accomplish their bioprocessing goals through either intensified, connected or continuous bioprocessing.
As the industry is looking to increase speed to market, reduce manufacturing resources and increase product safety, there has been a push to implement single-use technologies. Combining both SPTFF and single-use technology can be a powerful tool for the efficient manufacture of biologics.
This webinar discusses several scaling approaches, such as constant tip speed, kLa, and power number-based scale-up.
This webcast reviews a research example for process development with the human tumor cell line H157, cultivated in stirred-tank mini bioreactors as 3D cell aggregates.
With 10 state-of-the-art facilities in North America and Europe, AbbVie Contract Manufacturing offers a wide range of global contract manufacturing capabilities.
With 10 state-of-the-art facilities in North America and Europe, AbbVie Contract Manufacturing offers a wide range of global contract manufacturing capabilities.
When you select AbbVie Contract Manufacturing for your biologics product, you’re partnering with a leading developer and manufacturer that is at the forefront of biopharmaceuticals with both our own products and customers’ products. Our scientific team and state-of-the-art facilities clearly demonstrate the capability to optimize success all the way from innovation to commercialization.
