Top News
FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico
Oct 13, 2017
Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.
Pharma Gives Update on Puerto Rico Manufacturing Operations
Sep 28, 2017
AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
Catalent to Acquire Cook Pharmica for $950 Million
Sep 19, 2017
The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.
BioPharm eBooks
Development Strategies for Emerging Therapies
Review the state of emerging therapies, roadblocks to development, patent implications, stem cell harvesting, purification of viral vectors, automation of cell-therapy manufacturing, vaccine delivery innovations, and research tools.
View ebook
Biopharma News
Japanese Agency Supports Daiichi Sankyo’s Genetic Vaccine Platform
Oct 16, 2017
Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.
Merck KGaA Opens New Life Sciences Center
Oct 16, 2017
The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.
FDA Expands Approval for J&J’s Psoriasis Biologic
Oct 16, 2017
Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.
Industry News
EMA Publishes Brexit Plan
The agency has published a continuity plan for its move from the United Kingdom.
Merck KGaA Opens New Life Sciences Center
The new center will serve as a regional hub where scientists and engineers can work with customers for biological development.
FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico
Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.
Supplier News
DCPrime and Apceth Biopharma Collaborate on Cancer Vaccines
The two companies announced their collaboration for the production and development of cancer vaccines.
DSM Sinochem Pharmaceuticals Files Patent Infringement Lawsuit
DSM Sinochem Pharmaceuticals has filed a lawsuit against CSPC Pharmaceutical Group, Inner Mongolia Changsheng Pharmaceutical Company, and CSPC Zhangnuo Pharmaceutical (Shijiazhuang) for infringement of its amoxicillin patent.
Temperature-Controlled Shipping Service Solution
Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.
Trends in Bioprocessing
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
The Importance of Buffers in Downstream Processing
Industry experts provide insights on the challenges and importance of using buffers in downstream processing.
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a biopharmaceutical facility design.
Upstream Processing
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.
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.
Downstream Processing
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
Harvest of Human Mesenchymal Stem Cells from Microcarriers
Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
Standards/Regulations
FDA Releases Guidance on Resolving Issues with the Agency
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
FDA Publishes Antiviral Guidance
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
Videos
Sponsored Videos
Sponsored eBooks
QbD and PAT in Biopharmaceutical Development
In this eBook, learn how the adoption of QbD and Process Analytical Technology (PAT) as well as Design of Experiments techniques help biopharmaceutical companies improve efficiency and accelerate time to market.
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Analytics
Optimizing Protein Aggregate Analysis by SEC
A UHPLC SEC approach for protein aggregate analysis of mAbs is presented.
Control Viral Contaminants with Effective Testing
Detecting viral contaminants in biologic-based medicines—and identifying their source—requires a holistic testing approach.
Accelerating Genetic Medicine R&D Using Microfluidics
This review examines how microfluidics has been used in the formulation, preclinical, and clinical development of gene-delivery nanoparticles.
Formulation
Formulation of Biologics for Non-Invasive Delivery
There is a lot of interest in delivering biologics via non-invasive routes in attempt to improve patient compliance and convenience.
Ajinomoto Althea Adds High Potency Capabilities
Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.
Accelerating Genetic Medicine R&D Using Microfluidics
This review examines how microfluidics has been used in the formulation, preclinical, and clinical development of gene-delivery nanoparticles.
Single-Use Systems
Singular Developments Advance TFF Technology
Single-use and single-pass TFF devices are facilitating advances in biopharma manufacturing.
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
Larger Peristaltic Pumps Allow Scale-Up for Biopharm Projects
Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.
mAb Development
NJII and Rutgers University to Form the New Jersey Continuous Manufacturing Institute
The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.
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.
BARDA Funds Ebola Vaccine and Drug Development
Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.
Vaccine Development
DCPrime and Apceth Biopharma Collaborate on Cancer Vaccines
The two companies announced their collaboration for the production and development of cancer vaccines.
Japanese Agency Supports Daiichi Sankyo’s Genetic Vaccine Platform
Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.
GSK’s Shingles Vaccine Approved in Canada
The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.
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Outsourcing
FDA Licenses Second Samsung BioLogics Facility
Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.
Up and Away, M&A
Mergers and acquisitions are positive for the CDMO industry, but there is a downside.
ADC Bio Invests $11 Million on Bioconjugation Facility
ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.
Current Issue
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.
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
Optimizing Protein Aggregate Analysis by SEC
A UHPLC SEC approach for protein aggregate analysis of mAbs is presented.
The Challenges of PAT in the Scale-Up of Biologics Production
Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.
Webcasts
Sponsored Whitepapers
CPhI Biopharma News
DSM Sinochem Pharmaceuticals Files Patent Infringement Lawsuit
DSM Sinochem Pharmaceuticals has filed a lawsuit against CSPC Pharmaceutical Group, Inner Mongolia Changsheng Pharmaceutical Company, and CSPC Zhangnuo Pharmaceutical (Shijiazhuang) for infringement of its amoxicillin patent.
Temperature-Controlled Shipping Service Solution
Almac Group’s Almac Pod, a temperature-controlled shipping solution service for biologics and other temperature-sensitive products, is available in the United States.
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