Solutions for Purifcation of Fc-fusion Proteins
Platform processes are valuable tools in process development. Applying them to complex fusion molecules made up of different structures, however, can lead to unexpected results. EA2 is a unique engineered molecule, and it did not fit well into a platform process. It does, however, have three potential affinity and pseudo-affinity sites, each target site having a platform purification unit operation. One site is the antibody Fc region for Protein A binding, but the product was too sensitive to low pHs for typical Protein A elution conditions, so a high pH elution process was developed instead. The other two pseudo-affinity sites proved to be unusable, as did ion exchange chromatography. The final process that was developed added hydrophobic interaction and mixed mode (HIC and AEX) chromatography polishing, with a solvent and detergent (S/D) treatment instead of the typical lowpH virus inactivation.This product points out the need for innovation and flexibility in cases where platforms do not work.
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Single-Use Technologies
A Contract Biomanufacturer’s Perspective
The closed and controlled environment of single-use technologies in a biopharmaceutical production process can significantly reduce processing time. A fully disposable option eliminates cross contamination, cleaning, and subsequent validation, reducing the use of water for injection. Lower operating costs, smaller equipment footprints, increased productivity, and rapid turnaround time are some of the major benefits that are driving the market demand for single-use technology in manufacturing. This article discusses a contract manufacturing organization’s perspective on the use of disposable technology in the biopharmaceutical production process.
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Cutting costs with contract manufacturing
Leading biopharmaceutical companies are finding that manufacturing and production offer tremendous opportunities to cut costs, reduce time and achieve overall excellence, and pharma companies eager to speed drug development cycles are increasingly turning to contract manufacturers to help streamline the process. But what challenges do they face in terms of choosing an outsourcing partner? And what issues need to be taken into consideration…
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Considerations for Aseptic Filling of Parenterals
Careful planning, innovative machine design, and rigorous attention to
detail will assure maximum product delivery and minimize timelines from project
initiation to completion. By the time a parenteral product arrives at our facility for
filling, a client has invested considerable time and significant resources in its
development and manufacture. Our experiences clearly demonstrate the
importance of planning and attention to detail for achieving a filling run that
enables that product to move efficiently to testing or market, helping to realize
the greatest value from…
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Bioprocessing and Partnering
There are a number of challenges facing the biomanufacturing industry,
from both the contract manufacturing organisation (CMO) and industry
perspectives. Biomanufacturing is a complex, labour-intensive and expensive
process and therefore it is extremely important to understand and balance
capacity versus demand and staffing level. Identifying, hiring, training and
retaining properly qualified personnel are very critical to the successful operation
of a facility, since biomanufacturing requires a very specialised and experienced
workforce. Staff must have technical expertise in specific areas including
upstream or downstream current Good Manufacturing Practice (cGMP)
manufacturing operations, process development, project management,
process engineering, quality assurance, analytical development, quality
control, regulatory compliance, and many other highly specialised functions.
Once on board…
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A rosy outlook for outsourcing biologics
Outsourcing providers have every reason to be happy. With an increasing volume
of new drugs entering the clinical trial pipeline, the usage occasions for contract
services are up. NGP spoke with Laureate Pharma’s Robert Broeze to find out how
he plans to become ‘most preferred CMO’.
Laureate Pharma can look forward to a future as impressive as its past. The contract
manufacturing organization (CMO) achieved record growth in 2006. It signed 14 new
agreements and increased its business backlog by more than 240 percent over 2005.
“We also increased our company workforce by more than 25 percent to handle the
ever-increasing workload. We are on track to completing the facility expansion,
and have added a new pilot production plant to expand the purification production
capacity,” says Robert J. Broeze, President and CEO.
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Facilitating Technology Transfer to Your CMO: How to ensure smooth technology transfers.
The following is a transcript of a podcast interview of Dr. Michael Ultee by BioPharm International, recorded at the 2008 BIO International Convention held in San Diego.
BioPharm: What are the biggest challenges in a technology transfer process? Are the challenges different at different stages of tech transfer?
Ultee: I think they are and they fall under a couple of categories. The first is the technical area. The processes that come to us arrive at different levels of development. If a process is already well developed, then it is essentially a pure technology transfer…
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