Features
– Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations. Similar to batch manufacturing, CM requires a comprehensive and holistic control strategy throughout the product life cycle to ensure, in a reproducible and consistent manner, the intended product

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iSpeak Blog
Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Thursday, 20 June | 0700–1800 Friday, 21 June | 0700–1600 Attendee Toolbox Attendee Roster: View the full list of workshop attendees. Presentations:...
iSpeak Blog
Discussion: In the introductory blog, “Direct to Patient: The Basics & Quality Considerations”1 a collaborating team of direct to patient (DtP) sponsors, couriers, CROS, and QPs introduced several direct to patient models for distribution of study...
iSpeak Blog
We are now less than five months away from the start of the 2019 ISPE Annual Meeting & Expo being held this year in Las Vegas! The 2019 ISPE Annual Meeting & Expo is the premier technical event where engineers from the pharmaceutical industry can meet,...
iSpeak Blog
The key to success in the lifecycle approach to process validation is robust process and product understanding. Scientific evidence regarding process performance, linking process parameters and raw materials (inputs) to quality attributes (outputs) is...
iSpeak Blog
The life sciences continue to represent a highly dynamic area of scientific advancements. Virtually every day, a new discovery opens up new possibilities for treating and monitoring diseases for which up to now treatment options were either limited or...
iSpeak Blog
Establishing and maintaining an appropriately skilled workforce for the future is one of the biggest difficulties facing international pharmaceutical corporations today. The workforce composition and skills requirements are also changing due to...
iSpeak Blog
Featured in this edition of ISpeak Reading Roundup are the top blog posts from May 2019. Discover trending industry topics, developments for the future of pharma, and more for what the pharmaceutical industry was reading last month. Pharma 4.0 – The...
iSpeak Blog
Buket S. Hekiman Bayraktar General Coordinator PharmaVision Can you tell me a little about yourself – your career, your interests, and your enthusiasm for...
iSpeak Blog
It seems every year is a year of great change in the Biopharma industry and for me, I know the conferences are where I find my grounding. I look forward to ISPE conferences both local and international because I get to catch up with dozens of networked...
iSpeak Blog
“The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug applications. Based on this activity, we anticipate that the number of product approvals...
iSpeak Blog
The promise and impact of new and rapidly evolving technology and capabilities is modernizing and transforming our global industry. Hence the theme of the 2019 ISPE Annual Meeting & Expo – Modernization, Globalization, and Transform. This theme is truly...
iSpeak Blog
The future landscape of biomanufacturing is changing at the most rapid pace in decades, so the biopharmaceutical professional of today must be prepared for what's new on the horizon in facilities and equipment, production, and process technology in order...
iSpeak Blog
In this evolving world of bioproducts and novel manufacturing approaches, consideration for the upcoming challenges in process validation requires innovation and collaboration among our collective industry leaders and our regulatory agencies. The...
iSpeak Blog
In today's pharmaceutical industry, process validation relies on information and knowledge from product development activities to ensure patient requirements are translated into product attributes. A key to success is establishing a comprehensive...
iSpeak Blog
As many recent pharmaceutical product quality problems have shown, current Good Manufacturing Practices (GMPs) as defined by regulatory guidelines and current best practices may not be “good enough” in the 21st Century. 1, 2, 3  Although, much of the...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup are the top blog posts from April 2019. See key industry topics, membership experiences, and more for what the pharmaceutical industry was reading last month. 2019 Pharma Best Practices –...
iSpeak Blog
A derivative of a trendy if not overused moniker, used by many other industries to convey a new start, a new future, and substantial change from the past. Is biopharma manufacturing really at such a juncture? The committee members organizing ISPE’s 4th...
Insights
Initially, the American College of Rheumatology urged caution around the use of biosimilars. Information about the manufacturing process for a branded biologic is proprietary; a biosimilar manufacturer will not have access to the details of the process, so how could they guarantee their product...
Technical
As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been...

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Featured Articles

Features
To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161...
Features
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements that are already underway....
Features
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated...
Features
It is the duty of the government to improve access to safe, effective, and quality medicines for its constituents. Various approaches are taken by different countries to achieve this; for the Philippines, the approach is through the active promotion of...
Features
In Japan, off-patented drugs are not always converted to generic drugs but may remain on the drug list as off-patented-drug products. These are customarily classified into three groups: patented drugs; off-patented drugs (“long-listed drugs”); and...
Features
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...
Features
The 2018 ISPE Quality Manufacturing Conference , held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...
Features
Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4 Pharmaceuticals, biotech, and API...
InTouch
Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
Features
Janssen is in the midst of a multimillion-dollar expansion project at the company’s Ringaskiddy, County Cork, manufacturing facility in Ireland. The 19,100-square-meter project is expected to significantly increase Janssen’s global manufacturing capacity for producing biologic medicines for...
Features
Our May-June cover story on the rise of biopharmaceutical manufacturing in Asia noted that “Biopharmaceuticals are booming … buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support.” 1 While that report focused principally on China, Indonesia,...
Technical
This article illustrates the importance of experimental conditions to evaluate analytical methods. Italicized text is used throughout the article to emphasize key points and illustrate formula variables.
Features
Innovative technology for in-line real-time powder flow monitoring based on drag force flow measurement offers great potential for efficient monitoring of powder-processing operations.
Special Reports
The ISPE Advancing Pharmaceutical Quality (APQ) team is developing a framework by which a company can assess its maturity in relation to quality culture, operational excellence, and ICH Q10 elements, using the CAPA system as the focus of the pilot.

In This Issue

Features
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations....