FEATURED ARTICLES

  • Sustainable Pharmaceutical Packaging
    Sustainable Pharmaceutical Packaging

    The concept of sustainability has been a topic of interest for many years. Cur-rent international focus has led to the development of regulatory guidance in many of the world’s markets. Along with sterility assurance, process validation, and regulatory compliance, sustainability is becoming a high-profile issue and is considered a critical factor in the design of healthcare facilities, equipment, products, and packaging. By Chuck Reed and Mel Bahr

  • Proving The Value Of Strategic Partnerships  - What Strong Relationships Can Accomplish
    Proving The Value Of Strategic Partnerships - What Strong Relationships Can Accomplish

    Let’s be clear about something right up front. This is not a story about the benefits of outsourcing laboratory services. Rather, this is an entirely different approach to lab research, development, and management services called co-sourcing, where on-site providers – often represented by a company’s own former employees – work hand-in-hand with staff scientists to maintain and oversee multi-vendor instrumentation and related services. By Gareth Temple and Stuart Dean

  • How To Prepare A Facility For The Biopharmaceutical Revolution
    How To Prepare A Facility For The Biopharmaceutical Revolution

    Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

  • Analytical QbD at Teva: Knowledge Is Power Only When You Share It
    Analytical QbD at Teva: Knowledge Is Power Only When You Share It

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

  • Pharmaceutical Customers In An Outsourcing Provider Merger -- Part 3 Of Interview With CEO of Newly Formed DPx Holdings B.V.
    Pharmaceutical Customers In An Outsourcing Provider Merger -- Part 3 Of Interview With CEO of Newly Formed DPx Holdings B.V.

    This final article in our series featuring Jim Mullen, CEO of newly formed DPx Holdings B. V., discusses how to keep the focus on customers during M&A activity, and the broader transformation of sponsor–provider relationships in the pharmaceutical outsourcing industry.

    Earlier articles from our interview with Mullen dealt with how an acquisition comes together, and the importance of understanding the relationship between quality, capacity and job security for the early success of any M&A deal. In some ways, we’ve left the most important subject – customers – for last.

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BIORESEARCH INSIGHT

  • Securing Provision K Status For A Client’s API Helps To Expedite Shipping And Reduce US Importation Costs
    Securing Provision K Status For A Client’s API Helps To Expedite Shipping And Reduce US Importation Costs

    Active pharmaceutical ingredients (APIs) also known as bulk active pharmaceutical ingredients, are defined by the US Food and Drugs Administration (FDA) as ‘any component that provides pharmacological activity or other effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or animals.’ Generally, APIs are therapeutic components of drug formulations or finished pharmaceutical products that also contain fillers, binders’ excipients and other inactive ingredients. APIs are routinely evaluated or used by pharmaceutical companies for preclinical testing during new drug development, human clinical trials testing and commercial manufacturing of approved pharmaceutical products.

  • Benefits And Risks Of (UV) Ultraviolet Radiation

    Soon after the discovery of microorganisms, biologists began to observe that many varieties of these creatures were able to be incapacitated by exposure to sunlight. Following the discovery of the ultraviolet bandwidth in 1801, scientists attributed the sun’s lethal effect to this invisible energy. Facilitated by the findings of a large body of experimental evidence collected in the decades following these initial hypotheses, contemporary scientists have determined that nearly all bacterial activity can be eradicated or at least attenuated by some wavelength of ultraviolet energy.

  • Utilization Of Customs Warehouses In The Clinical Trial Supply Chain

    The global clinical trial supply chain industry has been seeking new opportunities to improve efficiency for many years. As pressures to decrease cost and reduce time to market continue to rise, the design of the clinical trial supply chain must evolve and change to meet those demands.

  • Following The Lead From Big Pharma Or Biotech May Not Identify The Right Supplier For Emerging/Niche Or Start-Up Companies

    A couple of years ago, Nice Insight explored how the essential qualities for outsourcing relationships varied between
    large and midsized companies, in addition to traditional pharma companies versus biotechs. As one would imagine,
    these essentials differ quite a bit from emerging or start-up companies, as their needs when it comes to outsourcing are different from larger companies’. 

  • The Evolving Role Of Drug Mechanism Of Action In Drug Discovery And Development

    Discovering a new drug can reduce pain and suffering, preserve and extend life, and facilitate procedures like surgery and recovery through anesthesia and pain management. Collectively, effective drugs and their appropriate use can support the creative and cultural activities of societies.

  • Outsourcing Biomanufacturing Continues To Grow In Frequency

    Nice Insight has learned from its strategic partnering surveys that the long-term strategies of many businesses in the pharmaceutical industry for maintaining a strong drug development pipeline include integration of biopharmaceuticals.

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FEATURED PRODUCTS

  • HyPerforma Single-Use Bioreactor Turnkey System
    HyPerforma Single-Use Bioreactor Turnkey System

    The Thermo Scientific HyPerforma® Single-Use Bioreactor Turnkey (TK) system combines the best features from our hundreds of single-use stirredtank bioreactors in use today with a state-of-the-art controller system.

  • CELLine™  Bioreactors Advanced Cell Cultivation Devices
    CELLine™ Bioreactors Advanced Cell Cultivation Devices

    In an effort to push science forward, WHEATON is manufacturing  a new line of membrane driven flasks for high density cell culture. The flasks are designed to enhance small scale bio-production for antibody and protein generation.

  • AT&T Cargo View with FlightSafe®

    Maximize visibility of your supply chain and improve transport operations of valuable cargo using AT&T Cargo View with FlightSafe®, a turnkey application that allows you to monitor and track global assets using near real-time location and sensor information.

  • Docu-Proof™ Text Inspection
    Docu-Proof™ Text Inspection

    Docu-Proof Enterprise is the first client-server solution on the market. It combines top notch text inspection technology with centralized user management for corporate wide deployment and superior inspections.

  • Southwest Airlines Cargo®: Fast, Efficient Shipping
    Southwest Airlines Cargo®: Fast, Efficient Shipping

    Southwest Airlines Cargo likes to keep things simple, and that's why we offer you effortless shipping with fast, efficient service. Shipping cargo can seem complex with a lot of rules, so here's our 101 lesson on how to ship with Southwest Airlines.

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BIORESEARCH ONLINE VIDEOS

  • Temperature Monitoring Technology for Healthcare Shipments
    Temperature Monitoring Technology for Healthcare Shipments

    Logistics expert Kevin O’Donnell, Senior Partner, Exelsius Cold Chain Management, presents the basics of temperature monitoring for healthcare shipments. From simple temperature indicators to more sophisticated electronic systems that include intervention protocols, you have more options than you may think. Kevin Etter, Product Manager, UPS Global Healthcare Logistics Strategy Group, explains why it’s so important to know what's going on during high value shipments.

  • How To Assess Total Logistics Cost
    How To Assess Total Logistics Cost

    Watch this new video to learn new ways to calculate total logistics costs. Susan Li of the Healthcare Strategy Group at UPS reveals the true costs of packaging and shipping.

  • Biobanking And The Future Of Translational Medicine: Dr Gyorgy Marko-Varga Interview 2 Of 3 Dr Gyorgy Marko-Varga highlights how biobanking will be critical to realize the promise of Translational Medicine and what challenges we need to overcome quality hurdles going forward.
More Videos

FEATURED SUPPLIERS

  • Colder Products Company
    Colder Products Company

    Colder is the worldwide leader in design and manufacture of plastic quick disconnect couplings for the life sciences, industrial, and chemical handling markets.

  • Thermo Scientific
    Thermo Scientific

    The Thermo Scientific HyClone product line in Logan, Utah helps to make the world healthier, cleaner and safer by producing leading cell culture products and bioprocessing systems for life-science research and protein-based drug production

  • Southwest Airlines Cargo
    Southwest Airlines Cargo

    At Southwest Airlines Cargo®, we understand the urgency of pharmaceutical shipments and know that sometimes overnight is not an option. With Relentlessly Reliable® air cargo service to over 90 destinations, we provide exceptional care so your time critical shipment will arrive ontime, as planned.

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BIORESEARCH ONLINE INDUSTRY PARTNERS

 

CMO CRO LEADERSHIP AWARDS

Life Science Leader developed the CMO and CRO Leadership Awards based on industry leading research conducted by Nice Insight. The awards help pharma and biopharm companies focus on potential partners who can handle their projects and are considered reputable in the industry. Click on the logos above to visit this year’s winners.

 

ABOUT BIORESEARCH ONLINE

Welcome to BioResearch Online, the premier Internet source of useful and timely information for the worldwide bioresearch and life sciences industries. This site is designed to serve the needs of laboratory directors, laboratory managers, researchers, scientists, university faculty members, business executives, and other industry professionals. BioResearch Online provides daily news updates and in-depth feature stories about drug discovery, research and development advancements, university-industry collaborations, and regulatory issues.

On this site, industry professionals will find information about new products and technology, bioanalytics, bioreactors, biopurification, bioproduction products, bioprocess sensors, cell culture media, biopharm contract manufacturing, chromatography, lab informatics, lab automation, laboratory systems and equipment, molecular and cell biology, pipettors, assay instruments, genetic sequencing, immunochemicals, enzymes, hardware and software systems, and more.

Bioresearch Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute.

Please take a moment to join our community and discover the benefits of your free membership.

 

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 UPCOMING TRAINING COURSES

Communication With FDA: What Do We Say And How Do We Say It?

July 23, 2014
1pm-2:30pm EDT, Online Training

Monitoring Informed Consent (IC): Frequently Asked Questions

July 24, 2014
1pm-2:30pm EST, Online Training

Remote Monitoring of Clinical Source Data – Why Not?

July 28, 2014
1pm-2:30pm EDT, Online Training

Building An Effective GMP Training System: A Risk-Based Approach

July 30, 2014
1pm-2:30pm EDT, Online Training

Improving Biological Facility Design: Critical Tips for Compliance

August 6, 2014
1pm-2:30pm EDT, Online Training
More Upcoming Courses

WEBINARS

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BIO EVENTS

Communication With FDA: What Do We Say And How Do We Say It?

July 23, 2014
1pm-2:30pm EDT, Online Training

Monitoring Informed Consent (IC): Frequently Asked Questions

July 24, 2014
1pm-2:30pm EST, Online Training

Remote Monitoring of Clinical Source Data – Why Not?

July 28, 2014
1pm-2:30pm EDT, Online Training

Building An Effective GMP Training System: A Risk-Based Approach

July 30, 2014
1pm-2:30pm EDT, Online Training

Improving Biological Facility Design: Critical Tips for Compliance

August 6, 2014
1pm-2:30pm EDT, Online Training
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