Top News

Catalent to Acquire Cook Pharmica for $950 Million

Sep 19, 2017

The acquisition adds to Catalent’s capabilities in biologics development, analytical services, manufacturing, and finished product supply.

FDA Issues Warning Letter to EpiPen Manufacturer

Sep 11, 2017

FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.

Explosions Rock Arkema’s Texas Peroxides Plant

Aug 31, 2017

Faced with unprecedented flooding from Hurricane Harvey and days of persistent rain, Arkema’s Crosby, TX, plant lost all power, causing flammable chemicals to ignite.

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

J&J and HHS Team Up on Flu Vaccine and Drug R&D

Sep 20, 2017

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

Wuxi Medical Instrument Factory Receives FDA Warning Letter

Sep 19, 2017

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

Gates Foundation Invests $40 Million in Immunotherapy Collaboration

Sep 19, 2017

The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.

Supplier News

Recipharm Announces in Manufacturing Pact with Roche

Recipharm has announced a long-term manufacturing pact with Roche, which includes the acquisition of Roche’s solid-dose manufacturing facility in Leganés, Spain.

Spectrum Chemical in Distribution Deal with Cole-Parmer

Spectrum Chemical announced an agreement with Cole-Parmer for the distribution of Spectrum’s USP fine chemicals.

Leistritz to Host Annual Twin Screw Extrusion Workshop

Leistritz’s Twin Screw Extrusion Workshop will take place on Nov. 29–30, 2017 in both Clifton, NJ and the NJ Leistritz facility, and will feature classroom sessions and equipment demonstrations.

Bio/Pharma News

J&J and HHS Team Up on Flu Vaccine and Drug R&D

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

Aplagon and Cadila Collaborate on Anti-Thrombotic Biologics

The partners will develop a lead anti-platelet, anti-coagulant (APAC) product for treating blood vessel wall injury. Clinical trials are set for 2019 in India.

EMA Recommends Approval of Herceptin Biosimilar

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

Standards/Regulations

Wuxi Medical Instrument Factory Receives FDA Warning Letter

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

Manufacturers Seek Strategies for Ensuring Quality of Innovative Therapies

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.

FDA to Promote Continuous Manufacturing

The agency is looking for industry input on best practices for continuous manufacturing.

Drug Development

AI Provides New Insights for Accelerated Drug Development

By identifying patterns, artificial intelligence and deep learning platforms help researchers discover new drugs faster.

Recipharm and Kancera Collaborate on Development and Manufacture of Cancer Drug

Kancera’s drug candidate KAND567 will be developed as a capsule formulation for oral administration. Work will be performed at Recipharm’s development facility in Solna, Sweden.

Four Challenges for Pulmonary Drug Delivery

Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how—with the right knowledge and expertise—these challenges can be overcome.

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

Congress Unlikely to Act on Drug Pricing Legislation This Fall

High-priority issues requiring immediate attention leave little time for Congress to consider drug access proposals that have limited bipartisan support.

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.

PharmTech Europe News

Oxford Genetics Opens First US Office

The company has extended its presence in the US market to support its growing business in the region.

EMA Hosts Antimicrobial Resistance Meeting

The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.

EMA’s PRAC Recommends Removal of Modified-Release Paracetamol

Experts noted that the mechanism of drug release for these products after an overdose could put patients at risk.

Peer-Review Research

Detection of Lumps in Powder Blends by Inline NIR

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.

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.

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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