In this eBook, Symbiosis explores the necessity to offer chemistry, non-sterile microbiology and sterile microbiology testing and the requirements for parenteral preparations.
Can CDMOs apply lessons learned from the COVID-19 pandemic to improve sterile processing?
A single protein or gene expression product can exist in multiple proteoforms due to alternative splicing, point mutations, post translational modifications and endogenous proteolysis.
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
A unified scale-up approach, as presented here, can be applied to any unit operation.
Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST
The steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.
Sponsors should explore key considerations ahead of choosing a new outsourcing partner.
Conversations with CMOs/CDMOs about capabilities and how they work to reduce complexities in the supply chain should focus on cost efficiency, temperature excursions, and sustainability.
Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.
As biotechnology organizations have successfully launched new products, the challenges of producing adequate quantities have grown. Many companies are now dealing with multiproduct manufacturing facilities and pushing the limits of their capabilities. One result of this complexity is a loss of production capacity due to inefficiencies.
Biodefense start-up companies have an abundance of options when seeking funding.
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
Choosing the right tools to enhance the process.
Can increase in ionic strength result in higher viscosity?
Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.
Productivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors.
Best methods to maximize product yield and membrane lifetime to enhance a tangential flow filtration process.
Productivities similar to those achieved with stirred tanks can be achieved with disposable bioreactors.
Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.
Contract manufacturers must plan for increased analytical resources in development and quality control.
An off-the-shelf, single-use perfusion system.
Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.