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Top News

Merck and Pfizer Collaborate with Corning to Modernize Pharmaceutical Glass Packaging

Jul 21, 2017

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

Endo Withdraws Opioid Drug from Market

Jul 10, 2017

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

FDA to Eliminate Backlog of Orphan Drug Designation Requests

Jun 29, 2017

The agency announced a plan to eliminate its existing orphan designation request backlog.

Biopharma News

GSK Plans Changes to UK Manufacturing Network

Jul 19, 2017

GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.

GSK Ships Seasonal Influenza Vaccines for US Market

Jul 17, 2017

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

Novartis CAR-T Cell Therapy CTL019 Recommended for FDA Approval

Jul 12, 2017

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

Standards/Regulations

EMA Recommends Five Orphan Drugs

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

FDA to Lead International Effort to Secure the Supply Chain

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Tubilux Pharma S.p.A. Receives FDA Warning Letter

The agency cited the Italian company for aseptic processing failures.

Industry News

EMA Recommends Five Orphan Drugs

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

New Guide Outlines Risks for Cross Contamination

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.

Report: Dose CMOs Stuck in Idle

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

Supplier News

Merck and Pfizer Collaborate with Corning to Modernize Pharmaceutical Glass Packaging

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

Avantor Opens New Collaborative Research Center in New Jersey

The Bridgewater facility will provide a range of contract services for biopharmaceutical and pharmaceutical manufacturers, and also serve electronics chemicals suppliers.

Nitto Denko Avecia Announces Manufacturing Expansion

The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.

Protein Aggregation Studies

Complementary Techniques for the Detection and Elucidation of Protein Aggregation

By Lisa Newey-Keane

The use of orthogonal methods to SEC is discussed; examples show how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation Matrix

By Hui Xiang, Derek Chan, Ronald Bates

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

By Ciaran Murphy

Resonant mass measurement can be used to detect and quantify the formation of protein subvisible particles and to detect and quantify any silicone droplets in a formulation.

Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein Aggregates

By Mark Cornell Manning, Ryan R. Manning, Ryan E. Holcomb, Charles S. Henry, Glenn A. Wilson

The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Upstream Processing

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.

Platform for Integrated Continuous Bioprocessing

Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.

Going from Fed-Batch to Perfusion

Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.

Downstream Processing

Best Practices for Data Integrity

Optimize practices and meet requirements using electronic data integrity systems.  

Harvest of Human Mesenchymal Stem Cells from Microcarriers

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Managing Residual Impurities During Downstream Processing

Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.

BioPharm eBooks

Outsourcing Resources
Nearly 60% of the bio/pharma companies responding to a recent BioPharm International survey outsource at least half of their crucial development and manufacturing tasks. In this ebook, the editors report on the biopharma–contract services relationship.   
View ebook

 

 

Videos

Sponsored Videos

Sponsored eBooks

Advances in Biopharmaceutical Characterization: Charge Variants and Aggregates
Experts discuss overcoming the challenges of developing mAb formulations using novel pH gradient methods for ion exchange chromatography that provide fast and reproducible mAb charge variant profiling. View eBook

 

 

A Journey Through the Protein Purification Workflow
Experts share best practices for downstream purification, and how continuous purification methods can offer increased productivity and greater process reliability and reproducibility in the laboratory and when scaling protein purification processes for the production of commercial quantities. View eBook

 

Fundamental UHPLC Workflows for Biotherapeutic Characterization
The introduction of UHPLC revolutionized bio/pharma analytical laboratories and advances in technology promise more for the future. In this e-book, experts explain recent advances in UHPLC, and the basics of glycan analysis. View eBook

Analytics

Biosimilars Overcome Legal and Analytical Hurdles

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

STR Profiling:  Authentication of Human Cell Lines and Beyond

Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.

Best Practices for Data Integrity

Optimize practices and meet requirements using electronic data integrity systems.  

Formulation

Catalent and Rutgers University to Study Pediatric Drug Challenges

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Fusion Proteins Pose Manufacturability Challenges

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

Witnessing Major Growth in Next-Generation Antibodies

Including next-gen antibodies in pharma pipelines is considered essential for future success.

Single-Use Systems

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.

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.

Biosafety Concerns of Single-Use Components

Single-use bags containing toxic or hazardous materials required special handling.

mAb Development

Platform for Integrated Continuous Bioprocessing

Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.

Intensification of a Chromatography Platform

The authors present a shift toward more integrated purification processes.

Fusion Proteins Pose Manufacturability Challenges

The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.

Vaccine Development

GSK Ships Seasonal Influenza Vaccines for US Market

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

Sanofi Acquires Protein Sciences

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

Malaria Drug Shown to Protect Against Zika, NIH Says

The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.

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