Taming the Scheduling Beast

By abandoning spreadsheets, Lonza has improved production planning at its Portsmouth facility. Read more »

Roche Gets to the Core of MES

The manufacturer’s global rollout of a centralized MES system will not happen quickly or easily, but is already resulting in error and deviation reductions in the 80%-90% range. Read more »

The “Intended” Consequences of Software Validation

Compliance specialist Michael Gregor puts the spotlight on software validation, and tells us why FDA is doing the same. Read more »

Tech Transfer: Do It Right the First Time

What dooms many tech transfer projects is a failure to communicate and plan. Read more »

Visit our Editor's Blog: On Pharma

We go behind consumer media headlines, beyond trade press boundaries, to offer candid analysis and commentary on issues affecting drug manufacturers. We cover the gamut, from fiscal to philosophical, from serious to silly. Read more »

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Audio Update

  • Podcast: Is Tech Transfer Broken? How Can We Fix It? We spend billions on drug development, yet precious few products make it to market. Could tech transfer be to blame? If so, why do so many companies get it wrong? In this first installment of our Focus On Pharma podcast series, sponsored by Thermo Scientific, tech transfer experts Stephen Perry, Russ Somma, Emil Ciurczak, and Paul McKenzie explore what’s broken with tech transfer, and how to fix it.
  • The Triple Bottom Line: A Strategy Tailor Made for Pharma CEO of Advanced Electron Beams, Mitch Tyson, discusses how pharma companies can strengthen their organizations, and their balance sheets, by adopting the TBL.
  • Podcast: This Is Not Your Father’s Coriolis: Flow Measurement Goes Micro We speak with Endress + Hauser’s Joerg Herwig about his company’s partnership with MEMS specialist Integrated Sensing Systems (Issys) and how E+H aims to take all of its products to the micro scale.
  • Podcast: Online TOC and Real-Time Release on the Global Stage In the second of this two-part series, Jonathan Yourkin, pharmaceutical market manager with GE Analytical Instruments, provides insight on navigating the subtle, and sometimes dramatic, differences between pharmacopeia and regulators in the U.S. and abroad in regards to the use of online TOC. Yourkin also shares best practices for applying TOC to PAT applications and real-time product release.
  • Puerto Rico 2.0: Repositioning an Industry to Restore a Competitive Edge No one needs to tell Puerto Rico the global pharmaceutical market has changed. The island is in the midst of a makeover that will focus on biotech, generics, and outsourcing its 40-plus years of expertise with the aim of keeping the island relevant to pharma. INDUNIV executive director Ivan Lugo talks strategy.
  • It’s Good to Be a Scientist: Life Sciences Job Market Holding Firm The turmoil in life sciences and merging of small- and large-molecule manufacturers only enhances the attractiveness of experienced scientists and engineers, says Kurt Moore, president of TalentWRx staffing agency. For those whose careers are in flux, making the most of a temporary position may open doors to something more permanent.
  • A World Beyond ICH: WHO, ISO Must Figure Prominently in Harmonization Regulatory harmonization has made great strides, but if efforts are to become truly global the World Health Organization must be involved. In this audio interview, Birgitte Holst, Manager of Manufacturing Science & Quality at Novo Nordisk, discusses pharmacopeia, terminology, anticounterfeiting, and more.
  • Maximize Uptime and Cycle Times with Rapid Microbial Methods Rapid Microbial Methods offer a much faster alternative to traditional plating to detect microbes in raw materials, in-process and finished goods. In this 15-minute audio interview, John Albright, Regulatory and Compliance Manager with Celsis, discusses the company’s Rapid Microbial platform, potential ROI and impact on capacity utilization and cycle times, as well as method validation.
Hear more from Audio Update »

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Webcast Library

  • Webcast: A Look Ahead: The Impact of Biosimilars on the Pharma Landscape Follow-on biologics, or biosimilars, will soon become reality in the U.S. Given their inherent complexity and the current state of analytics, how will their safety and quality be ensured? Will they boost or diminish competition and innovation in biotech? Join us for a thought-provoking presentation and panel discussion of these issues.
  • Webcast: Tech Transfer: Do We Have a Failure to Communicate? Failure to transfer an analytical method or to move a process from lab to plant can cripple drug development efforts, wasting millions of dollars each year. Why do tech transfer projects fail? How can one ensure their success, whether one is transferring to another department or to a contract manufacturing organization? Join us for a controversial presentation and panel discussion of these issues.
  • Webcast: Agility and the Pharmaceutical Facility of the Future Economic realities and market pressures demand agility in pharmaceutical manufacturing as never before. What technologies promise to transform laboratories and manufacturing facilities as we know them today? What will the typical pharma plant look like in twenty years? In this webcast, experts share their views on transformative technologies, existing facilities that set new benchmarks for the industry and what the future holds. Q & A to follow the speaker's presentations.
More webcasts »