Top News

Sanofi and Boehringer Ingelheim Sign on Business Unit Swaps

Jun 27, 2016

The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.

Next Steps Uncertain for the UK Pharma Industry Post Brexit Vote

Jun 24, 2016

In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.

CAR-T Optimized to Target Solid Tumors in Animal Models

Jun 21, 2016

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

Biopharma News

Sanofi and Boehringer Ingelheim Sign on Business Unit Swaps

Jun 27, 2016

The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.

Adaptimmune and Thermo Fisher Collaborate on Manufacture of Cell Therapies

Jun 23, 2016

The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.

Kalytera Appoints Robert Langer to Scientific Advisory Board

Jun 23, 2016

Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.

Industry News

NIH Researchers Develop Clinical-Grade Stem Cell Line

The cell lines have the potential to provide new medical applications for patients suffering from Alzheimer’s disease, Parkinson’s disease, spinal cord injury, diabetes, and muscular dystrophy.

ICH Discusses Global Drug Development and Biopharma Guidelines

ICH detailed the highlights of the council’s June 2016 meeting.

FDA Provides Quality Metrics Technical Conformance Guide

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

Supplier News

GE Healthcare Opens Life Sciences North American Headquarters in Boston Area

A new facility in Marlborough, MA, will house laboratories to support GE Healthcare Life Sciences’ biomanufacturing and development operations.

Thermo Fisher and NIBRT Link Up for Characterization Project

Thermo will provide access to its instruments to NIBRT so that the Dublin-based group can generate helpful characterization data.

Lonza Sponsors Horseshoe Crab Conservation Initiatives

Lonza will continue to sponsor the conservation of horseshoe crabs, which are used in endotoxin testing.

Upstream Processing

Pfizer Builds Biologics Clinical Manufacturing Facility in Massachusetts

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

CMC Biologics Will Manufacture F-star mAb² Bispecific Antibodies

The collaboration will provide GMP manufacturing ahead of future clinical studies.

Fujifilm Diosynth Announces Collaboration With MSD on Large-Scale Biologics Facility

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.

Downstream Processing

MilliporeSigma Expands California GMP Facility

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Headspace Moisture Analysis for Determination of Residual Moisture Content in Lyophilized Pharmaceutical Products

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

The Importance of Buffers in Downstream Processing

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.

Formulation

Janssen Alleges HyClone Lab Infringed its Cell-Culture Media Patent

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

Removing Troublesome Solubilizing Excipients from Injectables

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

Althea Patents Method to Crystallize Proteins

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

CPhI Biopharma News

CPhI Accepting Applications for 2016 Pharma Awards

The annual CPhI Pharma Awards honor companies and individuals driving the pharmaceutical industry forward through innovation, new approaches, technologies, and strategies.

Market Opportunities to be Explored at CPhI Japan

Generic drugs, market access, and foreign manufacturing are conference topics at CPhI Japan 2016.

Peer-Review Research

A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

Size-Exclusion Chromatography for Preparative Purification of Biomolecules

The authors provide application data to support the use of SEC beyond small-scale operations.

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Standards/Regulations

ICH Discusses Global Drug Development and Biopharma Guidelines

ICH detailed the highlights of the council’s June 2016 meeting.

FDA Provides Quality Metrics Technical Conformance Guide

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

EMA Recommends Suspension of Riluzole Alkem

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

Analytics

FDA Approves Use of Zika Virus Assay

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

Controlling Glycosylation for Improved Product Quality

Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.

Essentials in Tolerance Design and Setting Specification Limits

Specification limits should be set early in drug development and refined in later phases as data becomes available.

Single-Use Systems

Bioprocessing Technology Marches On

Advances in single-use systems, consumables, and continuous manufacturing show steady progress.

MilliporeSigma Expands California GMP Facility

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Qualification and Validation of Single-Use Shipping Systems

The authors provide their perspectives on shipping validation.

mAb Development

Atezolizumab: Soon to Be a Monotherapy?

New research presented at the American Society of Clinical Oncology meeting demonstrates that atezolizumab could be a promising first-line therapy for the treatment of bladder cancer in cisplatin-ineligible patients.

Seattle Genetics Presents New Antibody-Drug Conjugate Data at AACR

Linker technology and drug combinations play an important role in the efficacy of ADCs.

Using Site-Specific Conjugation for Homogenous Bioconjugates

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

Vaccine Development

Study: HIV-1 Neutralizing Antibodies in Infants May Impact Vaccine Development

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

Anthrax Vaccine Nabs Orphan Drug Status

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

GE Healthcare Sells Rights for Inactivated Yellow Fever Vaccine to PnuVax

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.

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