Top News

Trek Therapeutics to Test Blockchain-Based Smart Contracts for Clinical Supply Chain Safety

Aug 16, 2017

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

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; President Trump signs legislation.

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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Industry News

CDER, CBER, and CDRH Directors Praise FDARA Reauthorization

Aug 21, 2017

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

FDA to Evaluate Pediatric Cough Medicines Containing Opioids

Aug 21, 2017

A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.

CPhI India Report Finds Two-Tier Manufacturing Market, Predicts Increased Acquisitions

Aug 18, 2017

CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.

Supplier News

Axol Bioscience Gets $3-Million Capital Investment

The private equity funding will enable the startup biotech firm to expand product development as well as sales and marketing capabilities.

Swiss CDMO Expands GMP Manufacturing Capabilities

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

Ultrapure Water System for Laboratories

Sartorius Stedim Biotech presents a new system for laboratories needing low volumes of ultrapure water.

Bio/Pharma News

Shire Announces Director and Senior Management Changes

Shire announced that CFO Jeff Poulton will be leaving the company at the end of the year. Additionally, Joanne Cordeiro has been appointed as CHRO.

Samsung Bioepis Partners with Takeda to Develop Novel Biologics

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

Biocon Withdraws Breast Cancer Biosimilar Filings in Europe

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

Standards/Regulations

CDER, CBER, and CDRH Directors Praise FDARA Reauthorization

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

FDA to Evaluate Pediatric Cough Medicines Containing Opioids

A meeting of the Pediatric Advisory Committee will advise on the use of prescription opioid medications containing hydrocodone or codeine in children’s cough medicine.

Compounding Pharmacy Warned About Unsterile Conditions

FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.

Drug Development

Samsung Bioepis Partners with Takeda to Develop Novel Biologics

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

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.

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; President Trump signs legislation.

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

Biocon Withdraws Breast Cancer Biosimilar Filings in Europe

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

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.

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

 

Modernizing Pharmaceutical Elemental Impurity Analysis
In this eBook, learn from experts at the US Pharmacopeia what drug companies need to know about USP <232> and <233>. Also learn about the use of atomic spectroscopy techniques and sample preparation procedures for elemental impurities analysis.  View E-Book

 

More E-Books

 

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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