December 6th 2024
Synthesis of DNA via cell-free methods has many benefits versus fermentation.
November 19th 2024
Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.
November 18th 2024
With financing led by OrbiMed, Novo Holdings, and Jeito Capital, Alentis Therapeutics will develop a pipeline of Claudin-1-targeted ADCs to treat solid tumors.
October 9th 2024
Space-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.
September 26th 2024
Stable cell line development can benefit from applying integrated analytical technologies.
A tidal wave of questions floats the need for more upstream automation.
Pall Debuts New Inline Diafiltration Modules for Continuous Bioprocessing
The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.
WuXi and Pall Establish Continuous MAb Manufacture
The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.
Celonic Acquires Glycotope’s Biomanufacturing Facility
CDMO Celonic acquired a biomanufacturing facility in Heidelberg, Germany from Glycotope.
Catalent and Grid Therapeutics Form Immuno-Oncology Pact
The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.
Platform Technologies Improve Protein Expression
Anna Kireieva/Shutterstock.comSpeed to market is essential in the biopharmaceutical industry today.
ABEC Develops Single-Use Bioreactor for Emergent Manufacturing Facility
ABEC, an equipment and engineering company, will provide a custom-made, single-use bioreactor to custom manufacturing firm, Emergent, for its Maryland manufacturing facility.
Batavia Biosciences Expands Viral Vector Facilities
The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.
Promethera and Shibuya Partner on New Cell-Therapy Manufacturing Platform
The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.
ProBioGen and Chiome in Antibody Manufacturing Deal
Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.
Groninger and Martin Christ Partner at CPhI Worldwide 2017
Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.
Sartorius Stedim Cellca Builds Laboratory and Office Facility in Germany
Sartorius begins building a new, EUR 30-million (US$35.2 million) Cell Culture Technology Center in Ulm, Germany.
Control Viral Contaminants with Effective Testing
Detecting viral contaminants in biologic-based medicines-and identifying their source-requires a holistic testing approach.
Molecular Cloning, Expression, and Purification of a Recombinant Fusion Protein (rNT-gp96-NT300)
. This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.
Harvest of Human Mesenchymal Stem Cells from Microcarriers
Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
End-to-End Cell Therapy Automation: An Immunotherapy Case Study
Consider automation early in the rollout of clinical translation and scale up of clinical-trial protocols.
Using Simulation to Address Capacity Limitations
Modeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
FDA Issues Warning Letter to US Stem Cell Clinic
FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.
AstraZeneca and Champions Oncology Partner on Xenograft R&D Models
AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.
Samsung Bioepis Partners with Takeda to Develop Novel Biologics
The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.
Pfizer Plans Gene Therapy Manufacturing Investment in North Carolina
Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.
Just the Biopharma Facts, Please
Amid debate about “fake news,” peer-review papers offer vital, objective insight.
Optimizing Cell-Culture Media
Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
The Role of Quality Standards for Biomanufacturing Raw Materials
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
ABEC Releases 4000-L Single-Use Bioreactor
ABEC increases the maximum capacity of its Custom Single Run Bioreactors to 4000 L, doubling the industry standard.
Intensification of a Chromatography Platform
The authors present a shift toward more integrated purification processes.
Going from Fed-Batch to Perfusion
Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.
Platform for Integrated Continuous Bioprocessing
Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.
SSB Integrates Automated Cell Culture Analyzer and Micro-Bioreactor
Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.