Boston, home to Fenway Park and the ever-famous Boston Red Sox, will host the 2019 ISPE Biopharmaceutical Manufacturing Conference. The city is known for its historic significance, professional sports teams, fine arts and delicious culinary options for...

Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Tuesday, 18 June | 0700–1700 Wednesday, 19 June | 0700–1700 Thursday, 20 June | 0700–1200 Exhibit Hall Hours Tuesday, 18 June | 1015–1800 Wednesday, 19 June |...

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...

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,...

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...

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...

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...

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...

Buket S. Hekiman Bayraktar General Coordinator PharmaVision Can you tell me a little about yourself – your career, your interests, and your enthusiasm for...

When I started in industry back in the mid-90’s, process validation was mostly a box checking activity. Many in industry would begrudgingly conduct slightly increased (e.g. 2x or 3x versus routine release) testing on validation batches without evaluating...

BACKGROUND Since the initial discussions on Cleaning Validation in the early 1990’s and even after the FDA Guidance was published in 1993, there has been a lot of confusion related to the application of the Cleaning Validation (CV) requirements in our...

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...

“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...

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...

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...

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...

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...

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...

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 –...

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...

In recent years, continuous manufacturing (CM) has gained a considerable amount of attention in the pharmaceutical industry. Although relatively new to pharma, it is widely applied in other industries where automated production techniques drive faster...