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
How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.
A guide for today’s biopharma executives seeking to navigate through the important considerations necessary to successfully build their own cGMP biomanufacturing facility.
Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.
With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.
Discover how through automation, it is possible to achieve data acquisition, process monitoring and control, and batch record generation, allowing more complex unit operations to be run in cGMP environments.
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