Top News

AstraZeneca Sells Antibiotics Business to Pfizer

Aug 24, 2016

The portfolio in this agreement include approved antibiotics Merrem, Zinforo, and Zavicefta, as well as candidates in clinical development, ATM-AVI and CXL.

Pfizer to Acquire Medivation

Aug 22, 2016

Pfizer will acquire Medivation for approximately $14 billion.

The CRISPR Patent Debate

Aug 19, 2016

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

PharmTech eBook Series

 

Bioprocessing & Sterile Manufacturing eBook
Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.   
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More E-Books:
2016 Solid Dosage Drug Development and Manufacturing eBook

 

PharmTech Supplements

 

Outsourcing Resources August 2016 Supplement
Read feature articles on the outsourcing industry, virtual pharma, aseptic manufacturing, supply-chain complexities, serialization, data integrity, stability testing, technology transfer, and CMO/CDMO investment trends.


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Industry News

“Go/No Go” Screening Process Can Help Decide Whether to Switch from Batch to Continuous

Aug 24, 2016

A recent paper outlines a methodology to help development teams decide whether switching from batch to continuous mode makes financial and technical sense.

Sagent Pharmaceuticals Issues Nationwide Recall

Aug 19, 2016

The company is voluntarily recalling one lot of Oxacillin for Injection, USP, 10 g.

The CRISPR Patent Debate

Aug 19, 2016

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

Supplier News

ACG APL Receives EXCiPACT Certification

ACG APL is the first empty hard capsule manufacturer in Asia to receive this certification.

Zenith Technologies Expands US Presence

The company is opening two offices in the United States that will offer serialization, automation, and process control services.

COC Designated by USP for Pharma Packaging

TOPAS Advanced Polymers announces its COC materials are compliant with new USP standard for pharma plastic packaging systems.

Bio/Pharma News

AMRI Licenses CRISPR from the Broad Institute

AMRI entered into a non-exclusive license agreement with the Broad Institute for the use of CRISPR-Cas9 gene-editing technology.

AstraZeneca Sells Antibiotics Business to Pfizer

The portfolio in this agreement include approved antibiotics Merrem, Zinforo, and Zavicefta, as well as candidates in clinical development, ATM-AVI and CXL.

Pfizer to Acquire Medivation

Pfizer will acquire Medivation for approximately $14 billion.

Standards/Regulations

The CRISPR Patent Debate

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.

Cetylev Tablets Recalled

Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.

Public Health Organizations Pen Letter to House and Senate Committees

Nine public health organizations submitted a letter to US House and Senate committees citing concerns about Section 11 of the FDA and NIH Workforce Authorities Modernization Act.

Drug Development

The BioRegion of Catalonia—A Unique Life-Sciences Hub in Europe

Barcelona is set to host two well-known pharmaceutical events in the upcoming calendar year: CPhI (October 4–6, 2016) and BIO Europe Spring (March 20–22, 2017). The city is the heart of the BioRegion of Catalonia, believed to be the most dynamic bioregion in Spain and one of the most active in Europe.

A Case for Orally Disintegrating Tablets

Industry experts discuss key considerations in the development of orally disintegrating tablets.

Global Fight Against Antimicrobial Resistance Gets Underway

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

Best Practices

Cleaning Limits—Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part II

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Optimizing Accuracy in Pinch Valves for Sterile Injectables

Preheating pinch valves prevents drift in the volume of liquid dispensed.

Best Practice: Developing Drugs that are Highly Potent

Highly potent or cytotoxic drugs require special handling

Current Issue

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

This paper describes a unique Prep-RP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

GMPs Creep into GDPs

Recent revisions to the European Union’s good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.

Going Green with Biocatalysis

Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.

PharmTech Videos

USP Supply Chain Safety Videos

Sponsored Videos

PharmTech Talk

When Marketing and Medicine Collide

Steep price increases for a popular drug have created patient and Congressional backlash.

Funding for Zika Vaccine Hinders Development

Zika vaccine development is hindered by technical challenges and funding shortfalls.

The Industry Hopes Congress Approves PDUFA Program in 2016

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

PharmTech Europe News

South Tees Bio-Incubator Launches in the UK

The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.

Novartis Expands Biologics Production in France

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

EMA Adopts Biologics Pharmacovigilance Practices

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

Peer-Review Research

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

This paper describes a unique Prep-RP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

Developing Cleaning Procedures for Oral Solid-Dose Manufacturing Equipment

This article examines using experimental design methods to define different procedures for intermediate bulk container cleaning. The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables.

Manufacturing Processes

Statistical Tools to Aid in the Assessment of Critical Process Parameters

By Ke Wang, Nathan D. Ide, Olivier Dirat, Ann K. Subashi, Nicholas M. Thomson, Kim Vukovinsky, Timothy J. Watson

A statistical approach determines when a statistically significant relationship between a process parameter and a critical quality attribute is large enough to make a practically meaningful impact.

Using the Guard Band to Determine a Risk-Based Specification

By Chris Burgess

Calculate a risk-based guard band associated with reportable values derived from knowledge of the analytical procedure capability.

The Role of Normal Data Distribution in Pharmaceutical Development and Manufacturing

By Kim Erland Vukovinsky, Lori B. Pfahler

Review challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment.

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

 

More E-Books:
Drug Development Application Handbook

 

CPhI Update

Judges for the CPhI Pharma Awards 2016 Named

CPhI Pharma Awards’ panel doubles in size and welcomes experts from around the world.

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.

Report: International Pharma Shows Confidence in China

International-domestic pharma partnerships will drive next wave of growth in China, according to new CPhI report on China.

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