Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.
Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.
Solving the bottleneck in gene therapy of manufacturing of viral material at sufficient cost and scale.
Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).
Biopharmaceutical R&D teams everywhere face the same dilemma in the development of biologics and vaccines: they must increase productivity to meet strict budgets and deadlines, while maintaining or improving data accuracy.
One of the major challenges in batch mammalian cell clarification is cost-effective improvement in filtration in the face of high cell densities. Single-use technology has serious benefits for flexibility in production, pilot or clinical batches, but with existing filtration equipment, the economic benefits have not been fully realized at volumes < 2,000 liters. Developers and CMOs alike require cell clarification technology that offers higher yields, fewer failures, and the ease of use of single-use, with reduced consumables costs for cost-effective drug development and production.
The production of monoclonal antibodies (mAb) and recombinant proteins has undergone significant progress in recent decades. Higher titers and increasing cell densities present challenges to upstream and downstream bioprocessing groups alike. In downstream processing, this challenge is quite clear (i.e., purification of larger product masses with currently available equipment/technologies is an on-going industry topic), but these changing conditions bring major challenges in upstream bioprocessing as well.
This paper delves deeper into aseptic sampling devices to explain how they offer superior performance in the effort to control contamination.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
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