Top News

Hospitals Launch Their Own Generic Drug Company

Jan 19, 2018

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

Drug Pricing Dominates Senate Hearing on HHS Nominee Azar

Jan 10, 2018

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

J&J Announces 15 New Collaborations

Jan 09, 2018

The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.

PharmTech eBook Series

 

Vaccines Development and Manufacturing 2017 eBook

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.  

View E-Book

 

Industry News

Hospitals Launch Their Own Generic Drug Company

Jan 19, 2018

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

Experts Partner to Optimize Lyophilization

Jan 18, 2018

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

Baxter Extends Recall of Nexterone

Jan 17, 2018

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

Supplier News

GE Healthcare to Equip Cell Therapy Manufacturing Facility with Single-Use Platform

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

Modular Automated Technology Allows Multiple Bioreactor Sterile Sampling

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

New Dividable Cryotube Allows for Multiple Sample Storage in Single Tube

1CryoBio’s Flexiquot technology allows for the deep-freeze storage and handling of multiple aliquots in a single tube, winning it the CPhI Pharma Award 2017 for Excellence in Pharma: Analysis, Testing, and Quality Control.

Bio/Pharma News

Locate Therapeutics Achieves ISO 13845 Certification for Development and Control of Manufacturing for Resorbable Biomaterials

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

Takeda to Acquire TiGenix

The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.

Athenex Hires German Engineering Firm to Build Manufacturing Facility

Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.

Standards/Regulations

Quality Issues Found at Canadian Facility

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

EU Suspends Modified-Release Products with Paracetamol

EMA recommends suspending the marketing of modified- or prolonged-released products containing paracetamol due to a difficulty in managing overdose.

FDA to Enforce Regulations of Unproven Homeopathic Drugs

The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.

Drug Development

Locate Therapeutics Achieves ISO 13845 Certification for Development and Control of Manufacturing for Resorbable Biomaterials

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

FDA and DoD Work Together to Provide Medical Products to Military Personnel

The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.

Charles River Laboratories Acquires KWS BioTest

The acquisition strengthens Charles River Laboratories’ capabilities in the oncology and immunology therapeutic areas.

Best Practices

Best Weighing Practices in the Pharmaceutical Industry

Understanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.

Maintaining Thermal Fluid Systems

Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.

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.

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

Sponsored Videos

PharmTech Talk

Drug Pricing Dominates Senate Hearing on HHS Nominee Azar

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

Tax Overhaul a Plus for Pharma

New tax legislation may result in savings for biopharma companies.

Contract Manufacturing Raises Regulatory Concerns

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

PharmTech Europe News

Locate Therapeutics Achieves ISO 13845 Certification for Development and Control of Manufacturing for Resorbable Biomaterials

The company is developing a pipeline of combination therapies using its patented polymer-based matrix delivery system, known as TAOS (targeted orchestrated signalling matrix).

Forecasting Bio/Pharma in 2018

Brexit-related challenges cast shadows on prospects for the European bio/pharma market in 2018, but optimism may let some sun shine through.

Infringement Procedure Against Roche Closed by EU

The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.

Peer-Review Research

Removing Subjectivity from the Assessment of Critical Process Parameters and Their Impact

A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation.

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.

Sponsored eBooks

 

Strategies for Accelerating Drug and Process Development
This eBook offers several approaches to meet these needs, including how to gauge the level and type of polymorph screening needed to minimize risk and how to implement Quality by Design during process development.

More eBooks

 

CPhI Update

Modular Automated Technology Allows Multiple Bioreactor Sterile Sampling

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

New Dividable Cryotube Allows for Multiple Sample Storage in Single Tube

1CryoBio’s Flexiquot technology allows for the deep-freeze storage and handling of multiple aliquots in a single tube, winning it the CPhI Pharma Award 2017 for Excellence in Pharma: Analysis, Testing, and Quality Control.

App Allows Patients and Physicians to “Target” Hives

ERT’s Target My Hives, an app for patients and physicians treating chronic urticaria, more commonly known as hives, aims to improve patient outcomes by integrating physicians and patient associations and facilitating communal support.

lorem ipsum