Top News

Eli Lilly CEO Announces Retirement

Jul 27, 2016

John C. Lechleiter will step down from his post as CEO of Eli Lilly effective December 31, 2016.

NIH-Backed Yellow Fever Vaccine Trial Announced

Jul 27, 2016

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

Jul 25, 2016

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

Biopharma News

Amgen: Neulasta Safe for Now; Dose Accuracy of Erenumab a New Focus

Jul 28, 2016

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

Eli Lilly CEO Announces Retirement

Jul 27, 2016

John C. Lechleiter will step down from his post as CEO of Eli Lilly effective December 31, 2016.

Merck Returns Rights to Allergy Tablets Back to ALK-Abello

Jul 27, 2016

The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.

Standards/Regulations

The Industry Hopes Congress Approves PDUFA Program in 2016

FDA and industry seek speedy Congressional approval of new user fee plan.

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.

Industry News

NIST Issues mAb Reference Standard

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

NIH-Backed Yellow Fever Vaccine Trial Announced

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

The Industry Hopes Congress Approves PDUFA Program in 2016

FDA and industry seek speedy Congressional approval of new user fee plan.

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

Avitide Plants Flag at Former Merck Location

The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.

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.

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.  
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Videos

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Sponsor's E-Books

 

Fundamental UHPLC Workflows for Biotherapeutic Characterization
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Analytics

NIST Issues mAb Reference Standard

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

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.

Formulation

NIST Issues mAb Reference Standard

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

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.

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

NIST Issues mAb Reference Standard

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

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.

Vaccine Development

NIH-Backed Yellow Fever Vaccine Trial Announced

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

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.

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