Top News

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.

Opioid Report Recommends Coordinated Effort to Fight Epidemic

Jul 17, 2017

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

Novartis CAR-T Cell Therapy CTL019 Recommended for FDA Approval

Jul 12, 2017

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

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

Testing and Sterility Deficiencies Found at Illinois Facility

Jul 25, 2017

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

Guidance Answers Questions on GDUFA

Jul 25, 2017

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

FDA Launches Expanded Access Tool

Jul 25, 2017

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

Supplier News

Cesca Receives Cellular Processing Patent for CAR-T Manufacturing

New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.

Corning and Gerresheimer Collaborate on Valor Glass

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

Lonza Launches New Biomanufacturing Complex

Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.

Bio/Pharma News

AstraZeneca, Merck & Co. in $8.5-Billion Oncology Collaboration

Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.

Takeda in Anti-Cancer Pact Worth Up to $340 Million

Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.

GSK Plans Major R&D Overhaul

Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.

Standards/Regulations

Manufacturers Struggle to Track Controversial 340B Drug Discounts

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

Want Faster and Cheaper with Higher Quality? Get it Right the First Time

Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.

Testing and Sterility Deficiencies Found at Illinois Facility

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

Drug Development

FDA Launches Expanded Access Tool

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

Report: Dose CMOs Stuck in Idle

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

Scientists Develop New Method for Determining Intracellular Bioavailability

The new label-free method for quantifying intracellular bioavailability can be used to predict drug exposure to target cells and hence its efficacy.

Best Practices

Data Integrity Best Practices

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

Addressing Security Risks in Connected Operations

A rigorous approach to industrial security is essential for protecting intellectual property and product integrity in connected pharmaceutical operations.

Countering the Loss in Efficiency Caused by Mandated Serialization Compliance

igital tracking of overall equipment effectiveness can improve efficiency.

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

Manufacturers Struggle to Track Controversial 340B Drug Discounts

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

Will the Pharmaceutical Industry Ever Get to Six Sigma?

A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.

Biosimilars Overcome Legal and Analytical Hurdles

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

PharmTech Europe News

Corning and Gerresheimer Collaborate on Valor Glass

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

Recipharm and LIDDS Establish Industrial Manufacturing Capabilities for Prostate Cancer Drug

Recipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.

EMA Recommends Five Orphan Drugs

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

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.

Understanding Containment

By Richard Denk

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.

Best Practice: Preventive Maintenance Keeps Tablet Presses Running Smoothly

By Matt Bundenthal

Tablet presses require regular inspection and maintenance to prevent premature wear and tableting problems.

Best Practices: Using Single-Use Systems in Aseptic Processing

By Jennifer Markarian

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

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

2017 CPhI Pharma Awards Open for Entries

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

Emergent BioSolutions Unveils Expanded Maryland Facility

The company held a ribbon cutting ceremony at its new Center for Innovation in Advanced Development and Manufacturing in Maryland.

Patheon Completes Expansion at Greenville Facility

The company invested approximately $26 million to update its sterile pharmaceutical and development service suites.

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