Top News

Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

Jul 25, 2016

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

Open-Access Technology Seeks to Make Drug Discovery Easier

Jul 21, 2016

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

No Clinically Meaningful Differences Between Herceptin and Amgen/Allergan Biosimilar

Jul 21, 2016

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

Biopharma News

Kite Collaborates with UCLA to Develop Off-The-Shelf Allogenic T-Cell Therapies

Jul 26, 2016

The company entered into an exclusive license agreement with UCLA for an artificial thymic organoid cell culture system.

Darzalex Secures Breakthrough Therapy Designation

Jul 26, 2016

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

AstraZeneca Begins Phase I Testing of its RNA-Based Therapeutic with Moderna

Jul 26, 2016

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

Standards/Regulations

Darzalex Secures Breakthrough Therapy Designation

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

EMA Suspends Drugs Due to Flawed Bioequivalence Studies

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

FDA Detects Deviations from CGMP at Denmark’s ALK-Abello

The company manufactures biological drug products and intermediates for the allergy vaccine market.

Industry News

CPhI Korea Returns to Seoul for Third Year

The conference will return to the COEX center in Seoul for the third year from August 23¬–25, 2016.

EMA Suspends Drugs Due to Flawed Bioequivalence Studies

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

Packaging Facility Gets FDA Warning Letter

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

Supplier News

Curida to Manufacture PCI Biotech’s Amphinex

Curida will manufacture PCI Biotech’s Amphinex, a drug used to treat bile duct cancer.

Zenith Appoints Serialization Director

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

Open-Access Technology Seeks to Make Drug Discovery Easier

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

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.

Upstream Processing

Novo Nordisk Expands Insulin Manufacturing Facility in Denmark

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Recognizing Biopharma Industry Excellence

CPhI Pharma Awards seek nominations for excellence in biopharma development and manufacturing.

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.

Downstream Processing

Recognizing Biopharma Industry Excellence

CPhI Pharma Awards seek nominations for excellence in biopharma development and manufacturing.

MilliporeSigma Collaborates with International Vaccine Institute

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

Contract Service Providers Gear Up to Develop Emerging Therapies

Technology advances enable contract service providers to keep pace with the demands of existing and emerging biologic-based therapies.

BioPharm eBooks

Outsourcing Resources
Mergers and acquisitions, the emergence of biosimiliars and cell therapies, complex supply chains, and increased regulatory scrutiny are a few factors shaping practices in the contact services market. The editors of BioPharm International examine recent trends, activities, and prospects for contract services on the scientific and business fronts in this special ebook issue.  
View ebook

 

 

Videos

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Sponsor's E-Books

 

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 E-Book

 

 

Analytics

Forced Degradation Studies for Biopharmaceuticals

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

Microbiological Testing: Time is of the Essence

Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.

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.

Formulation

Are Oral Peptide Drugs on the Horizon?

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

Forced Degradation Studies for Biopharmaceuticals

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

Bioprocessing Technology Trends of RNA-Based Therapeutics and Vaccines

The authors present an overview of the types of RNA-based therapeutics in existence and their optimal methods of manufacture, purification, formulation, and delivery.

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

Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

MilliporeSigma Collaborates with International Vaccine Institute

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

Pre-exposure to Dengue Virus May Predict Reaction to Zika Virus

Antibodies to dengue may either confer protective immunity to the Zika virus or enhance disease severity in secondary, related infections such as Zika.

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