Top News

FDA Recalls PharmaTech Liquid Products for B. cepacia Contamination Risk

Aug 11, 2017

FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination.

Congress Meets Deadline for Reauthorizing FDA User Fees

Aug 08, 2017

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

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.

PharmTech eBook Series

 

Biologics and Sterile Manufacturing 2017 eBook
New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.
 
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More E-Books:
2016 Quality Throughout the Supply Chain

 

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.


View Supplement

 

Industry News

2017 Chem Show to Focus on Plant Operations

Aug 16, 2017

The 2017 Chem Show announced the focus of the event’s latest installment taking place from October 31 - November 02, 2017 at the Javits Center in New York City.

Catalent Applied Drug Delivery Institute Appoints Jim Spavins to Advisory Board

Aug 15, 2017

Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.

Canadian Manufacturer Receives FDA Warning Letter

Aug 14, 2017

The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.

Supplier News

Cancer Genetics to Acquire Australian CRO

The $12-million acquisition will strengthen Cancer Genetics Inc.’s (CGI) capabilities in drug discovery, drug development, and early phase clinical trial testing in the field of oncology.

Lonza Announces New Endothelial Cell Application Center

Lonza announced an endothelial cell application center, which expands Lonza’s support for researchers.

Industrial Vacuum for Fine Powders and Combustible Dusts

The MDL15 combustible dust air-vac from Vac-U-Max is part of the company’s industrial vacuum cleaning product range for combustible dusts and offers high-volume cleanup of powders and combustible dusts.

Bio/Pharma News

Aslan Pharma Partners with Taiwan for Cancer Drug

A research collaboration joins Aslan with an academic research institute for studying small-molecule cancer drug candidates.

GSK Opens $57-Million Vaccines Facility in UK

GlaxoSmithKline (GSK) opened a new vaccine manufacturing facility in Montrose, Scotland. The £44 million (US$57 million) facility will be used to manufacture aluminum salts, which are used for vaccine production.

Regeneron Halts Development of RSV Biologic

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

Standards/Regulations

Canadian Manufacturer Receives FDA Warning Letter

The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.

ICH Announces Training Program

A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.

China Joins ICH Global Harmonization Efforts

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

Drug Development

EMA Increases Support for SMEs

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

A Continuous Improvement Metric for Pharmaceutical Manufacturing

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

Best Practices

Treating Halogenated Hydrocarbon Emissions from Pharmaceutical Production

Regenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.

Understanding the Potential of Artificial Intelligence Across the Pharmaceutical Lifecycle

Artificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.

Data Integrity Best Practices

Electronic systems allow biopharma manufacturing companies to meet data integrity requirements and optimize practices.

40 Years of PharmTech

PharmTech Reflects on Four Decades of Bio/Pharma Innovation
Pharmaceutical Technology marks 40 years of publishing for the bio/pharma industry reviewing advances and changes in technology, science, regulatory oversight, and patient care.
 
View the special coverage

PharmTech Videos

USP Supply Chain Safety Videos

Sponsored Videos

PharmTech Talk

Drug Supply Chain Tracking Challenges FDA and Manufacturers

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

Congress Meets Deadline for Reauthorizing FDA User Fees

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

Manufacturers Struggle to Track Controversial 340B Drug Discounts

Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.

PharmTech Europe News

CordenPharma Adds Manufacturing Line for Vet Drug Products

CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.

EMA Increases Support for SMEs

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.

EMA Unveils Brexit Plan

The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.

Peer-Review Research

Analysis of Total and Transferrin-Bound Iron from Serum Samples

Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.

A Forensic Microscopy Approach for Identifying Subvisible Particulates in a Sterile Ophthalmic Solution

In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.

Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning Validation

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.

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

What Country Ranks Highest in Pharma Manufacturing?

CPhI survey seeks industry input to rank top-performing nations on pharma manufacturing and business factors.

Predictions from CPhI Annual Reports—How Accurate Were They?

The CPhI expert panel predicted in past annual reports the advancement of QbD, continuous processing, and a rise in FDA warning letters.

2017 CPhI Pharma Awards Open for Entries

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

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