Top News

Merck Returns Rights to Allergy Tablets Back to ALK-Abello

Jul 27, 2016

The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.

GSK Unveils GBP275M Investment Plans in UK Manufacturing

Jul 27, 2016

The investment will be spread across three sites: Barnard Castle in County Durham; Montrose, Scotland; and Ware, Hertfordshire.

Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

Jul 25, 2016

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

PharmTech eBook Series

 

Bioprocessing & Sterile Manufacturing eBook
Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.   
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2016 Solid Dosage Drug Development and Manufacturing eBook

 

Industry News

GSK Unveils GBP275M Investment Plans in UK Manufacturing

Jul 27, 2016

The investment will be spread across three sites: Barnard Castle in County Durham; Montrose, Scotland; and Ware, Hertfordshire.

Global Fight Against Antimicrobial Resistance Gets Underway

Jul 26, 2016

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

Talon Compounding Pharmacy Issues Recall

Jul 22, 2016

The company voluntarily recalls all lots of lyophilized HCG and sermorelin.

Supplier News

Saneca Pharma Secures Contract Manufacturing Agreement with Xantis Pharma

CDMO Saneca Pharma has sold registration dossiers for more than 20 pharmaceutical products to Xantis Pharma and will hold an exclusive five-year contract manufacturing agreement for the products with Xantis Pharma.

Powder Systems Limited Installs High-Containment Filter Dryer in Australian API Manufacturing Plant

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

Recipharm Expands Blow-Fill-Seal Capacity at France Facility

The company will invest €18 million in its Kaysersberg facility to expand blow-fill-seal capacity.

Bio/Pharma News

Merck Returns Rights to Allergy Tablets Back to ALK-Abello

The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.

Kite Collaborates with UCLA to Develop Off-The-Shelf Allogenic T-Cell Therapies

The company entered into an exclusive license agreement with UCLA for an artificial thymic organoid cell culture system.

Darzalex Secures Breakthrough Therapy Designation

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

Standards/Regulations

The Industry Hopes Congress Approves PDUFA Program in 2016

FDA and industry seek speedy Congressional approval of new user fee plan.

Darzalex Secures Breakthrough Therapy Designation

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

FDA Detects Deviations from CGMP at Denmark’s ALK-Abello

The company manufactures biological drug products and intermediates for the allergy vaccine market.

Drug Development

Global Fight Against Antimicrobial Resistance Gets Underway

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

Open-Access Technology Seeks to Make Drug Discovery Easier

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

FDA Adjusts Review Timeline to Keep Up with Orphan Drug Demand

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

Best Practices

Optimizing Accuracy in Pinch Valves for Sterile Injectables

Preheating pinch valves prevents drift in the volume of liquid dispensed.

Best Practice: Developing Drugs that are Highly Potent

Highly potent or cytotoxic drugs require special handling

Best Practice: Choosing Glass Or Polymer For Parenteral Packaging

Consider the 3 Ps (product, process, and patient) when choosing a parenteral packaging material.

Current Issue

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

Ensuring Supply Chain Safety

Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.

More inspections, and regulator collaboration, offshore

China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.

PharmTech Videos

USP Supply Chain Safety Videos

Sponsored Videos

PharmTech Talk

The Industry Hopes Congress Approves PDUFA Program in 2016

FDA and industry seek speedy Congressional approval of new user fee plan.

MedPAC Recommends Changes to Medicare Drug Coverage

Pressure is mounting to reduce costs and spending on prescription drugs.

US and EU Regulators Seek to Reduce Pharma Inspections

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

PharmTech Europe News

Global Fight Against Antimicrobial Resistance Gets Underway

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

EMA Recommends Approval of First HIV Pre-Exposure Prophylaxis Drug in the EU

The agency has recommended granting marketing authorization in the EU for Truvada.

EMA Suspends Drugs Due to Flawed Bioequivalence Studies

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

Peer-Review Research

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

Developing Cleaning Procedures for Oral Solid-Dose Manufacturing Equipment

This article examines using experimental design methods to define different procedures for intermediate bulk container cleaning. The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables.

Ruggedness of Visible Residue Limits for Cleaning Validation

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

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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

CPhI Korea Returns to Seoul for Third Year

The conference will return to the COEX center in Seoul for the third year from August 23¬–25, 2016.

Report: International Pharma Shows Confidence in China

International-domestic pharma partnerships will drive next wave of growth in China, according to new CPhI report on China.

CPhI Accepting Applications for 2016 Pharma Awards

The annual CPhI Pharma Awards honor companies and individuals driving the pharmaceutical industry forward through innovation, new approaches, technologies, and strategies.

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