Biopharmaceutical companies need to consider intellectual property issues early on, even at the start-up stage.
As companies evolve, they often must select new locations where they can centralize or expand their operations. This can be a daunting challenge that demands consideration of numerous factors.
Patents are litigated in the biopharmaceutical industry perhaps more often than any other form of IP
Development guidelines for MAbs serve as a blueprint for their manufacture, safety, and efficacy testing.
The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.
Subcutaneous administration is likely to be an important factor in generating an immunogenic response.
The purpose of the PAT initiative is to move analytical laboratory functions close to the manufacturing process to improve manufacturing efficiency and product quality.
Various methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
Transgenics can substantially reduce capital investment and lower production costs through economies of scale and more flexible scale-up.
We often assume we know what success looks like for our partner, but we never ask them, or take the time to write it down.
In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.
The authors present the results of a survey of biologics manufacturers to evaluate how these manufacturers transfer analytical methods.
Downstream process design can increase facility output through improved overall process yield or higher batch capacity in mass and volume.
The concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.
The concentration range of proteins in human plasma spans approximately twelve orders of magnitude, with 85 to 90% of the protein mass distributed across as few as six proteins.
Various methods for transfecting molecules such as DNA, RNA, proteins, or drugs with high efficiency and low toxicity have been implemented and optimized for many different cell types. These include widely used techniques such as chemical transfection (lipid-based techniques), the use of viral vectors and electroporation.
Using packed columns in process development activities limits the scope for appraising a large and diverse range of media.
Development guidelines for MAbs serve as a blueprint for their manufacture, safety, and efficacy testing.
Protein expression remains an arduous task that involves a complex decision tree. Establishing tools and optimal conditions for each protein remains an empirical exercise.
There are challenges aplenty in purification and analysis of PEGylated protein pharmaceuticals. Here are a variety of technical solutions, many concentrating on the chemistry of the linker.
Historically, the big pharmaceutical companies (Big Pharma) have sought to feed their marketing machines by manufacturing blockbuster drugs—chemical-based, one-type-fits-all products that treat chronic conditions such as heart disease or arthritis. This approach has yielded recurring revenue streams from large patient populations. In contrast, biotechnology companies typically have created protein-based drugs,or biologics, to treat acute or niche conditions and diseases. With few exceptions (such as the biotech giant Amgen), biotech companies have foregone doing the marketing and sales of their drugs themselves, and have, instead, relied on others to perform their marketing and sales functions.
Trademark protection in the US is based on a dual system of federal and state laws.
Misinterpreting the effluent profiles obtained during tracer measurements performed for determining packing quality can often lead to excessively large percolation velocities and exaggeration of packing problems. Highly useful and reliable information can be obtained through characterization of tracer effluent curves using the method of moments, information that could be critical for successful scale-up of chromatographic steps. This is the sixth in the "Elements of Biopharmaceutical Production" series.
An analysis of current and upcoming industry challenges.
Downstream process design can increase facility output through improved overall process yield or higher batch capacity in mass and volume.
Nearly every process conducted in a biotechnology company requires analytical methods to back it up. Since BioPharm's last guide published in December 2001,1 scientists have developed exciting, new tools for conducting research. Listed here is a sampling of new technological developments unveiled in 2005.
In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.
Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."