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.
 
View E-Book

 

Industry News

ISPE 2017 Annual Meeting & Expo Keynote Speakers Announced

Sep 25, 2017

Keynote speakers for ISPE’s 2017 Annual Meeting & Expo include representatives from AstraZeneca and GSK.

Global Effort to Stop Sale of Illegal Drugs Advances

Sep 25, 2017

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

Will Interchangeability Boost Biosimilar Prescribing?

Sep 25, 2017

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

Supplier News

ADC Bio Invests $11 million on Bioconjugation Facility

ADC Bio announces plans to expand into clinical and commercial drug manufacturing for ADCs.

Cambrex Adds Reactors to Facility in Sweden

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

UPS Reveals Supply Chain Security System

UPS has revealed a new system to improve drug supply chain security, in compliance with the Drug Supply Chain Security Act (DSCSA).

Bio/Pharma News

Merck & Co.’s Keytruda Gets FDA Approval for Gastric Cancer

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

AbbVie Partners with BMS for Combined Lung-Cancer Therapy

The collaboration will evaluate the combination of BMS’ Opdivo immunotherapy with an investigational antibody drug conjugate in development by AbbVie.

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.

Standards/Regulations

Global Effort to Stop Sale of Illegal Drugs Advances

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

Will Interchangeability Boost Biosimilar Prescribing?

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

Preparing for the Inevitable: Key Steps for Weathering a Pharmaceutical Recall

Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.

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

Will Interchangeability Boost Biosimilar Prescribing?

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

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.

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

CPhI Pharma Awards 2017 Finalists Revealed

Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 24, 2017.

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.

lorem ipsum