Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?
Transferring production – and the technologies that undergird it – can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.
The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.
As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help. At a CPhI North America panel on single-source CDMOs, four industry experts discussed how working with a single-source CDMO partner can accelerate time to market, add cost savings, and improve a formulation’s chances of achieving regulatory success.
In the pharmaceutical industry, speed is of the essence. As drug developers face increasing pressure to get formulations to market as efficiently as possible, the CDMO industry is evolving to meet this need. The Patheon OneSource™ model exemplifies the benefits of an end-to-end supply chain model for pharmaceutical and biopharmaceutical clients by accelerating time to market, adding cost savings, and putting formulations on the path toward regulatory success. Following a CPhI North America panel discussion about single-vendor CDMOs, Anil Kane, executive director and global head of formulation sciences at Patheon, discusses his views on this subject.
A single vendor offers access to a network of experts across several disciplines who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. Following a CPhI North America panel about single-source CDMOs, Paul Nelson, vice president of supply chain and R&D at Amring Pharmaceuticals, discusses his experience with single-source CDMOs.
A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
CMOs can empower their sponsors or customers to conduct many of these activities on their own products or processes through better data transparency.
Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.
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