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With the rising demand of gene therapies, aseptic processing practices are changing rapidly

Modern therapies add emphasis to the industry-wide need to take advantage of new technologies and explore new ways of addressing process control.

The high risk involved with biopharmaceuticals means there are high demands placed on the hygienic design of bioprocessing equipment.

It would be foolish to underestimate the risk associated with aseptic drug processing

Pharmaceutical and biopharma manufacturers need to move fluids from one cleanroom to another quickly, with maximum productivity and minimal effort and expense.

This white paper explains the many different factors — some obvious and some not so obvious — that determine the cost of robot ownership.

Learn how to use the GAMP methodology to select and validate monitoring system software

Effective viral clearance is at hand with the new, biodegradable J.T.Baker® Viral Inactivation Solution. A sustainable alternative to Triton X-100, this cGMP-ready solution supports...

Have you heard? Experts at Mesa Labs wrote the biological indicator chapter in Handbook of Validation in Pharmaceutical Processes, Fourth Edition. Read the second part of their...

While regulatory compliance is a complex and cumbersome requirement for pharma manufacturers, it is key to ensuring patients receive quality products. Today's ever-increasing ...

Hot off the press! Read the last segment of the biological indicators chapter in Handbook of Validation in Pharmaceutical Processes, Fourth Edition by the experts at Mesa Labs...

Biological indicator professionals at Mesa Labs contributed to the Handbook of Validation in Pharmaceutical Processes, Fourth Edition. Read the first part of their chapter "Biological...

At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We ...

New, complex therapies coming through the pharma pipelines are putting immense pressure on supply chains and manufacturing capacity, challenging traditional scale-up and manufacturing...

For the past year, the pharma industry has been in the spotlight, as drugmakers unite to tackle COVID-19.

As more pharma companies look to lower costs, streamline operations, and expand geographical presence, contract manufacturers are increasingly becoming the unsung heroes of pharma...

Outsourcing to contract manufacturers can be a valuable, even critical, option allowing companies to focus their resources and talents on their primary objectives

Drug manufacturers and contract organizations have shared a mutually beneficial relationship for decades in the pharmaceutical industry and will no doubt continue to do so for...

Pharma’s Top CMOs are playing to their strengths, toning operations and flexing their technical muscles in an effort to compete.

Contract service companies are emerging as the industry's prime movers, tasked with providing the industry with a growing list of increasingly complex services, from early stage...

The manufacture of a Highly Potent Active Pharmaceutical Ingredient (HPAPI) compound can present many challenges due to the complex handling required for toxic substances.

An abstraction layer that provides data modeling, contextualization, and conditioning is required to efficiently leverage industrial data at scale.

Whether you face challenges like siloed data across multiple departments or addressing specific data security issues or simply feel restricted by the business applications you...

Without the right data management systems in place, data is nothing more than spreadsheets of wasted opportunity for improvement.

High concentration mAbs can create challenges for subcutaneous injection, namely pain at the injection site. This peer-reviewed article compares buffer formulation options, and...

Over 70% of potential research participants live >2 hours away from sites, & patient drop-out rates can reach 30% depending on the therapeutic area. The Solution: eConsent Why...

Cell culture processes are complex and highly variable, and yet only a handful of key parameters are typically controlled in real time. Critical process parameters and key performance...

The pharmaceutical industry is under intense pressure to reduce the environmental harm caused by drug development and manufacturing. Learn about Green Chemistry principles and...

Now more than ever, it is important to protect employees, contractors, and anyone else who accesses your facility's roof. Making rooftop safety a priority at your location can...

Today’s pharmaceutical industry is facing big expectations and opportunities.

For the past year, the pharma industry has been in the spotlight, as drugmakers unite to tackle COVID-19.

The industry’s most established dosage forms, solid dose drugs are shelf stable and easy to administer. But today's drug formulations are complex and high potency, and OSD drugmakers...

The generic and biosimilars industry has positioned itself as the solution to the challenge of skyrocketing health care costs.

Generics step up to the plate, challenges and best practicies for manufacturing biosimilars and excipient trends

How is the pharma industry progressing on this vital journey?

Dragos's annual ICS/OT Cybersecurity Year in Review provides an overview and analysis of ICS vulnerabilities, global threat activity targeting industrial environments & industry...

The power of simulation in designing a pharmaceutical manufacturing process is due to the unique and detailed information it can provide for many operations. Learn more in this...

Dragos's annual ICS/OT Cybersecurity Year in Review provides an overview and analysis of ICS vulnerabilities, global threat activity targeting industrial environments, and industry...

There are many factors that can affect medication access and initiation. With the power of AI and predictive analytics, patient support interventions can be optimized to allow...

Digital technology is continuing to play a widening role in the pharma world — at least, for companies willing to begin the transformation

The traditional model for the pharmaceutical industry has focused on the development of blockbuster, broad-spectrum medicines that treat millions of patients globally. However...

Parenteral drugs are taking a strong position alongside the more established oral solid dose forms and are quickly coming into their own.

Biopharma R&D spending by PhRMA members grew from $2 billion in 1980 to some $51.6 billion in 2013. While no one’s crystal ball can exactly predict where the industry is headed...

In biopharmaceutical development, scale up and scale down are critical to developing a robust process and maintaining product quality. This eBook is a resource for best practices...

Pharmaceutical packaging products are getting cleaner, safer, and smarter than ever, and deciding how to choose a supplier requires more thought. Leading producers are laser focused...

Industry survey indicates pharma’s need to move towards a single, connected label management solution.

Once viewed as a mundane part of the business, primary packaging of pharmaceuticals has morphed into a hotbed of creativity.

Pharmaceutical packaging plays a critical role in ensuring the efficient distribution and safe consumption of the world’s drug supply.

Packaging format, materials and innovation have become an interesting discussion of critical importance to the pharmaceutical and biopharmaceutical industry.

Imagine the total number of pharmaceuticals being packaged every day, readied for patient consumption around the world – perhaps too many to count accurately. That is where machine...

What if you could achieve faster off-gas composition analysis without sacrificing precision and quality? Learn how to gain improved precision, accuracy, long intervals between...

Are you working with a pharmaceutical product that requires deep cold storage? Studies have shown that deep cold storage temperatures can introduce risk to the container closure...

Biotechnology and pharmaceutical industries continue to experience increased pressure on financial performance due to several factors, including a rise in the cost of raw materials...

Bringing the Pharma industry closer to it's CAPA goals requires a systematic approach. This special report presents the results and analysis of a recent industry survey indicating...

Supply chain collaboration is underleveraged in the pharmaceutical industry. Other sectors have put more focus on managing their supply chain, but most of pharma’s collaboration...

Oral solid dose drugs — the pharma industry’s most established dosage forms — are cost-effective to manufacture, shelf stable and easy to administer.

Oral solid dose formulations — the pharma industry’s tried-and-true treatment forms — continue to play a pivotal role in the industry’s quest to produce quality, effective treatments...

With more than a century of safe, effective usage, oral solid dose products are a proven pharmaceutical market mainstay. While the dosage form isn’t fading away any time soon,...

While the oral solid dosage form has not seen what OSD subject matter expert Dave DiProspero calls a “silver bullet change,” the sector has continued to stay relevant.

Seeking Agile, Excellent Oral Solid Dose Operations

Pharmaceutical manufacturers are looking to advance the efficiency and quality of manufacturing solid dose products that are often increasingly complex.

In this paper, Rudolf Schick, director of Spray Analysis and Research Services for Spraying Systems Co., discusses the "why" and "how" of optimizing pharmaceutical spray coating...

Over the last several years, pharmaceutical leaders have come to realize that their old ways of supply chain management are vastly inadequate for today’s hard-hitting challenges...

A start-to-finish guide for understanding and evaluating equipment move options.Organizations need to find the move system that will keep their operations moving swiftly, efficiently...

This year in particular, the pressure has been on pharma to keep pace with the ongoing demand for pandemic products, while also meeting the needs of rapidly expanding areas of...

In the highly regulated pharma industry, technological changes and progress tend to become evident relatively slowly.

Pack your bags and join the editors of Pharma Manufacturing as we examine the state of pharma beyond the borders of the United States, exploring the pluses and minus of different...