eBooks & Reports

Latest Ebooks and Reports

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eBook: Quality & compliance

Upholding rigorous quality standards is not only a regulatory imperative but also vital for ensuring the efficacy and safety of pharmaceutical products. And as many pharma manufacturers...

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Energy as a Service: Fortune 500 Insights on Risk Transfer and Sustainability

Nine out of 10 Fortune 500 executives surveyed expressed interest in the idea of outsourcing energy operations to reduce risk. Learn how an Energy as a Service model can support...

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Navigating data integrity compliance

Discover insights into FDA's Data Integrity Guidance and how to leverage the Cloud to achieve GMP compliance.

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A Paperless Future: How Blue Mountain Revolutionized Asset Management at AmplifyBio

Discover how Blue Mountain's Regulatory Asset Manager (RAM) propelled AmplifyBio, a leading Contract Research Organization (CRO), into a paperless future.

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Harnessing the Power of Industry 4.0 for Life Science

Leverage the latest advancements in technologies to drive innovation and deliver improved patient outcomes.

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Innovate with confidence: Smoothing the path to successful mRNA manufacturing

mRNA-LNP manufacturing is fraught with obstacles, resulting in higher program risk, inflated costs, and delayed market release. With the right knowledge, companies can overcome...

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5 ways dust collectors help ensure a controlled environment when tableting APIs

During tableting processes, APIs become airborne. These dust particles can harm workers, reduce air quality, contaminate products and cause explosions. Learn how dust collectors...

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White paper: Stop sweating temperature excursions

Advanced chemical indicators give you the peace of mind that comes from reliable insights into your supply chains.

Containment & Cleanrooms

Contract Manufacturing

Data Management/Analytics

Development

Facilities

Generics

Information Technology

Large Molecule

Op Ex & Lean Six Sigma

Aseptic Processing eHandbooks

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White paper: The chilled future of RNA therapeutics — Filling & freezing applications

Aseptic filling & freezing of single-use bags are often performed manually and uncontrolled, leading to inefficiencies and increased product loss. Only modular technologies facilitate...

eBook: Aseptic processing trends 2018

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

eBook: Aseptic processing trends 2017

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

Special report: Addressing process contamination risks

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

eBook: Advances in aseptic processing — Keeping risk and contamination at bay

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

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White paper: Applying single-use efficiencies to room-to-room fluid transfer

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

Automation & Control eHandbooks

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eBook: Weighing automation in production

This eBook provides guidance for automating weighing processes by highlighting tips and solutions that deliver value for all roles in manufacturing. This includes engineering,...

eBook: Automation & smart pharma 2022

Learn more about the latest smart pharma topics in this eBook.

Special Report: Pharma automation and control

This new automation and control resource guide covers these topics, and more, in depth

eBook: Smart pharma 2021

ISPE believes moving to Pharma 4.0 represents a competitive advantage to the extent that not embracing its potential might be a business risk for pharma companies.

eBook: Smart Pharma 2018

Today’s developing environment — coined the Fourth Industrial Revolution and characterized by rapidly evolving and disruptive advances in technology — has created a new and intimidating...

eBook: Smart pharma 2017

It’s not too late for the pharmaceutical industry to dodge its reputation for being behind other industries in terms of adopting technology.

Special Report: The Time is Right for Virtualization

In this special report, we explore how virtualization can provide significant advantages for deploying process control systems at pharmaceutical plants.

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White paper: Small assembly robots — Comparing the cost of ownership between brands

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

Compliance eHandbooks

eBook: Compliance & regulatory trends 2023

The pharma industry is often recognized as one of the most regulated industries in the world — and for good reason.

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White paper: Aggregation solutions for product traceability

Aggregation makes tracing products through each step of the supply chain much simpler. This in turn means that should one of those individual products show up elsewhere, it has...

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White paper: Tips for tailoring eConsent for optimal patient centricity

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...

eBook: Compliance & regulatory trends 2022

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 ...

Containment & Cleanrooms eHandbooks

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White paper: Cleanroom solutions for the pharma industry

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 ...

Contract Manufacturing eHandbooks

eBook: Contract manufacturing trends (Fall 2023)

The pharma industry is under pressure to speed new drugs to market, lower manufacturing costs and expand into new markets — and they are looking for partners who can help. CDMOs...

eBook: Contract manufacturing trends (Fall 2022)

The relationship between drug sponsors and CDMOs is key to the success of much needed pharma products.

eBook: Contract manufacturing trends (Spring 2022)

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

eBook: Contract manufacturing trends (Spring 2021)

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

eBook: Contract manufacturing trends (2020)

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

eBook: Contract manufacturing trends 2018

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

eBook: Contract manufacturing trends (2017)

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...

eBook: Contract manufacturing trends (2016)

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

Data Management/Analytics eHandbooks

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White paper: DataOps — The missing link in your industrial data architecture

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

Special report: Advancing pharma 4.0 with data fabric

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...

Research report: Data — the land of lost opportunity

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

Development eHandbooks

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White paper: Revolutionizing microbial bioproduction with chemically defined fermentation media

Learn more about how the innovation of chemically defined microbial media has created a new paradigm of microbial bioprocessing, one which has the potential to enhance the performance...

White paper: In-line real-time monitoring of CHO cell culture process parameters using Raman Spectroscopy

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...

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White paper: Using CFD to improve crystallization

Drug manufacturers charged with developing, scaling up or scaling down any process involving crystallization face major challenges, given the industry's current understanding ...

Facilities eHandbooks

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Compressed air engineering handbook

Get in-depth yet highly accessible technical expertise of compressed air technology necessary for pharmaceutical manufacturing.

White Paper: Rooftop Safety Audit Guide for Pharmaceutical Manufacturing Facilities

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...

eBook: Facility trends 2022

With utility costs on the rise, many pharma manufacturers are taking a closer look at their facilities and finding that better facility design, resource management and maintenance...

Research report: The true value of real-time microbial monitoring

With many pharma manufacturers operating sophisticated (and costly) continuous water purification systems, results that come days after a sample has been taken do little to ensue...

Research report: The true impact of machine failure in pharma

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

eBook: Pharma preparedness

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

eBook: Facility trends 2021

Often taken for granted until something goes wrong, facility design, resource management and maintenance strategies can offer sources of overlooked savings.

eBook: 2020 Facility Trends

Managing a pharma facility involves coordinating many moving parts: plant operations, personnel, and the utilization of assets, resources and space.

Generics eHandbooks

eBook: Generic Drugs 2019

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

eBook: Generic Pharma 2018

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

Information Technology eHandbooks

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Research report: OT cybersecurity concerns in pharma

How is the pharma industry progressing on this vital journey?

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White paper: Accelerate digitization in pharma manufacturing with IIoT and MQTT Sparkplug specification

Are you looking to overcome data connectivity challenges, optimize supply chain, & ensure regulatory compliance? Read this whitepaper showcasing a novel solution based on MQTT...

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White paper: Mastering simulation in pharma

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...

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Case study: Improving therapy initiation with an AI-guided patient support program

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...

eBook: Smart Pharma

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

Large Molecule eHandbooks

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eBook: Biopharma trends 2023

The U.S. is the largest pharmaceutical market by value and its drug spending has continued to outgrow the global market — and this is largely driven by biologics, which have seen...

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White paper: Personalized medicine — Succeeding beyond the blockbuster

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

eBook: Biopharma trends

The pandemic underscored what we already knew to be true for biopharma industry: We need to make therapeutics faster and more affordably.

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eBook: Biopharma trends 2021

Biologic drugs have profoundly transformed modern medicine.

eBook: 2020 Biopharma Trends

There’s no denying that biopharma drugs will play a vital role in the future of medicine.

eBook: Biopharma Manufacturing Trends 2019

How slow-motion trends are driving biopharma growth, the dangerous impact of unproven stem cell therapies and more.

eBook: Liquid dose trends

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

eBook: Biopharmaceutical Technical Resource Guide

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...

Op Ex & Lean Six Sigma eHandbooks

eBook: 2023 Pharma Innovation Awards

Discover new technologies that have upped the game for drugmakers

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White paper: Implementing 5S workplace organization methodology in manufacturing facilities

“A place for everything, and everything in its place” is the mantra of the 5S method

Packaging eHandbooks

eBook: Pharma packaging trends 2022

Packaging plays many roles in today's pharma industry. Not only does the right packaging protect drug quality, it can further sustainability initiatives and even create a strategic...

Special report: Modern pharma packaging supply strategies

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...

eBook: Pharma packaging 2021

Packaging plays a critical role in safeguarding the quality of the world’s drug supply.

eBook: Packaging Trends 2020

Packaging plays a critical role in ensuring the quality and efficient distribution of the world’s drug supply.

eBook: Packaging Trends 2018

Packaging systems vendors are more closely considering space, simplicity and flexibility in new designs

Research Report: Filling Pharma’s Label Management Void

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

eBook: Packaging trends 2016

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

Pharmaceutical Packaging Trends eBook

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

Quality & Risk eHandbooks

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How to Guide: Building a business case for a digitalized QC platform

Discover five steps required to help create a compelling business case and get the key facts and figures you need to achieve senior buy-in for a digitalized QC Platform.

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Why should CDMOs adhere to the new CDER's Rating System?

Dive into excellence: Discover how FDA's QMM program & CDER's rating system empower CDMOs to ensure top-quality pharmaceuticals, prevent shortages & build reliability. Uncover...

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Guide: Hygienic design considerations for weighing equipment

Contamination can lead to costly recalls, a damaged reputation, and ultimately harm to customers. Learn how to check your weighing equipment for key hygienic features and find...

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Application note: Monitoring pharma solvent drying processes

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...

eBook: Quality 2022

In the pharma industry, quality is an area where this is no room for compromise. As such, manufacturers' pursuit of quality enhancements is ongoing.

Special Report: Efficiency gains for pharmaceutical QC

When it comes to pharmaceutical water, anything less than perfection is a risk.

eBook: Quality 2021

In pharma, quality is a high-stakes business — not only measured in dollars, but more importantly, impacting patient lives.

Research Report: Exploring Pharma's CAPA Challenges

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...

Security eHandbooks

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White paper: Prepare your cyber defenses & learn how to protect your critical assets

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

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Report: ICS/OT cybersecurity year in review 2021

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...

Small Molecule eHandbooks

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Case study: Manufacturing dry powder media from development to large-scale cGMP production

Learn the process and results of a two-phase scale-up strategy that was used for three complex dry powder medium products.

eBook: Solid dose trends 2023

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...

eBook: Solid dose trends 2022

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

eBook: Solid dose trends 2020

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...

eBook: Solid Dose Trends 2019

The buzz may be around biologics, but the oral solid dose sector is still going strong

eBook: Solid dose trends 2017

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,...

2016 Solid Dose Trends

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.

eBook: Solid Dose Spotlight

Seeking Agile, Excellent Oral Solid Dose Operations

Unit Operations eHandbooks

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eBook: Best of Pharma 2023

A collection of the most-read feature articles of the year, chosen by the Pharma Manufacturing digital audience.

eBook: Pharma innovation 2022

Discover recently launched or updated technologies and systems that have changed the game in pharmaceutical manufacturing across several areas.

eBook: Best of pharma 2022

A collection of the most-read feature articles of the year, chosen by the Pharma Manufacturing digital audience

Special report: Digital transformation for greater supply chain resilience

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...

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White paper: Selecting the right system to move biopharma equipment

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...

eBook: Predictions and trends

While change does not always happen quickly in the pharma industry, the ongoing global pandemic has quickened the pace of emerging trends.

eBook: Best of pharma 2021

A collection of the most-read feature articles of the year, chosen by the Pharma Manufacturing digital audience.

eBook: Pharma Innovation 2021

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...

Other Resources.

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White paper: A path to 24/7 success for your company

Learn how digitalization can drive 24/7 success in your facility with our newest white paper.

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White paper: System integration in liquid handling

Considerations for obtaining optimal results in laboratory and medical devices

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White paper: Adopting novel technologies to improve mAb processes

Are purification strategies for mAbs moving you forward, or holding you back?

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White paper: Approaches to alleviating subcutaneous pain at injection sites

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

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White paper: Enhancing virus clearance process capability using a biodegradable detergent

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...

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White paper: Advantages of dry vacuum technology for pharma processes

Vacuum technology plays a crucial role in pharmaceutical processes (conveying, inertization, distilling, and drying). Using the most efficient vacuum technology can make these...

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Case study: Maintaining quality and equivalency in custom cell culture media manufacturing from development to large-scale cGMP production

Challenges can arise when transitioning a media formulation from a non-cGMP prototype to a cGMP-manufactured product. Our case study outlines the scale-up process that was used...