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Managing Complex Pharma Projects

In corporate culture, operational excellence, pharmaceutical by Generis0 Comments

As the pharmaceutical landscape is evolving to adjust to external effects, the demand for efficiency within the internal pharma industry is at a high. Praxis Life Sciences, who is reputable for analyzing challenges within an industry workforce and creating solutions based on quantitative and qualitative research has just released a new beneficial case study to the pharma industry. Their consultation within the life sciences field has a track record of proven results, and their most recent study, Managing Complex Pharma Projects, is no exception to this. The challenge that most pharma companies are currently facing is the inefficiency created by having a large project team with “disparate decision makers.” Praxis Life Sciences has analyzed this problem, and created solutions ensuring that ” decisions and progress are made in a timely fashion.” To learn more about the results of their case study, click here.

Cost-Effective Range of 48-Hour Pre-Qualified Temperature Controlled Shippers

In biotechnology, Generis, generis group, healthcare technology, Life sciences, manufacturing, manufacturing operations, medical device, pharmaceutical by Generis0 Comments

Using just three types of refrigerants and four shippers to create 12 solutions, the Certis® 2-Day Platform maximizes the number of solutions while minimizing the number of components. The new platform is sized to accommodate 7, 13, 27 and 56 liters of product. Each of the new solutions feature a year round pack-out designed for use in both hot and cold seasons. To learn more about qualified temperature controlled shippers, check out this article by Sonoco!

Smart Outsourcing: Strategic Alignment, Risk Management, and New Relationships

In biomanufacturing, healthcare technology, Life sciences, logistics, manufacturer, manufacturing, marketing, medical device, pharmaceutical, technology by Generis0 Comments

Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials. The industry is rapidly changing; companies are facing rising costs, a fast evolving global market, and weak pipelines. Many companies are outsourcing activities that have historically been kept in house, freeing themselves to concentrate on their core competencies and become more agile in responding to changing conditions. These new outsourcing models include discovery and R&D, regulatory, chemistry and manufacturing controls (CMC) support, and back office sales and marketing activities—virtually no activity is out of bounds. Instead of building or acquiring specialized technologies and facilities, many companies are seeking access to them elsewhere. Smart outsourcing provides the following operational and business benefits: To learn more about smart outsourcing and what the operational and business benefits are, check out this white paper by OQSIE 

Understanding the Hidden Costs of Weak GMP Documentation and the Return on Investment for Strong GMP Documentation

In biomanufacturing, business, Generis, generis group, manufacturing, pharmaceutical, production efficiency by Generis0 Comments

In your experience, when an organization has invested in proper documentation, what have the results been like? The results have been tremendous! We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements. In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients. To learn more about GMP documentation, check out the ebook by Bulletproof below! 

Managing Your Cold Supply Chain to Ensure Your Vaccinations Get to Where They’re Needed Most

In biomanufacturing, Generis, generis group, healthcare technology, innovation, Life sciences, logistics, manufacturing, mfg, pharmaceutical, production efficiency, supply chain, technology, testing by Generis0 Comments

World Courier is transporting Zika diagnostic test kits to and from South America. Companies trust us to transport and store time- and temperature-sensitive products, and the urgent and sensitive Zika diagnostic test kits are no exception! In the midst of concerns, especially for the well-being of athletes, World Courier’s capability and expertise are another reason to have peace of mind. The Zika virus was a huge fear for the 2016 Olympic summer games in Rio de Janeiro, Brazil. In the white paper below, World Courrier explains the process and challenges of transporting Zika tests for the 2016 Olympic games to ensure the safety of the Olympic athletes and those attending. Take a look at the full white paper below!

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Optimizing Temperature Control for Biopharmaceuticals

In biomanufacturing, biotechnology, Generis, industrial markets, innovation, Life sciences, logistics, manufacturer, manufacturing, mfg, pharmaceutical, quality, Quality by design, risk management, safety, supply chain, system design, technology by Generis0 Comments

This article first appeared in BioPharm International, October 1, Caroline Hroncich Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey. This article by World Courier delves into these relevant industry topics: Common considerations for shipping biopharmaceuticals; Temperature management in extreme climates; Recent advancements; and Looking ahead. Learn more about optimizing temperature control for biopharmaceuticals in the article below!  

The Serialization Challenge

In biomanufacturing, biotechnology, capacity management, Continuous Improvement, Life sciences, manufacturing, pharmaceutical, Serialization by Generis0 Comments

Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights. The eBook explores and explains: The Current Regulatory Landscape The Serialization Challenge Best Practices in Serialization Operationalizing a Serialization Program Check out the eBook below! eBook, The Serialization Challenge To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!    

Managing A Cold Supply Chain

In biomanufacturing, Life sciences, logistics, manufacturing, pharmaceutical, traceability by Generis0 Comments

In the build up to the American Biomanufacturing Summit, we sat down with James Klingelhoefer, Regional Sales Director at World Courier to discuss strategies to best manage a cold supply chain. In the article below, James discusses the challenges and opportunities in managing a cold supply chain, explains the most important elements to manage and provides advice to biomanufacturers who may be struggling with their cold supply chain management. Managing a Cold Supply Chain To hear more biomanufacturing insights, join the discussion on May 10 – 11, 2016 in San Diego, CA.

Video: Christopher Murphy’s Experience At The American Biomanufacturing Summit

In biomanufacturing, biotechnology, cGMP, Continuous Improvement, cost management, cost reduction, Enterprise Excellence, innovation, Life sciences, manufacturing, pharmaceutical, Qbd, QMS, traceability, workforce by Generis0 Comments

At the American Biomanufacturing Summit last May we had the opportunity to sit down with one of our key speakers, Christopher Murphy, VP, Operations at Genzyme to hear his thoughts on participating as a speaker and on the summit as a whole. The American Biomanufacturing Summit is returning to the Hyatt Regency La Jolla in San Diego on May 10th – 11th, 2016.  To find out more about the two day summit taking place next month, visit: www.biomanamerica.com

eBook: Q&A with Brandon Varnau, Vice President and Head of Operations Quality, Sanofi Specialty Care

In biomanufacturing, biotechnology, cGMP, Continuous Improvement, facilities, Life sciences, manufacturing, pharmaceutical, Qbd, QMS, Quality by design by Generis0 Comments

Our next eBook features industry insights and forecasts from Brandon Varnau, Vice President and Head of Operations Quality at Sanofi Speciality Care, one of the key speakers at the American Biomanufacturing Summit 2016. We asked Brandon: How biomanufacturing in the U.S. differs from international operations? What are the biggest challenges biomanufacturers currently face? How can these challenges be overcome? What is the biggest opportunity in biomanufacturing? What do you foresee as the ‘next big trend’ to influence biomanufacturing? What major changes to you forecast the industry undergoing over the next 5-10 years? eBook Q&A with Brandon Varnau Brandon joins the speaker line up in San Diego this May to discuss strategies to Create a Quality Compliance Culture Within Biomanufacturing Facilities: Aligning manufacturing and quality objectives to ensure compliance Developing clear compliance expectations for all staff Empowering staff to proactively engage in a culture of compliance Examining various channels and knowledge sharing platforms to communicate compliance practices Find out more about the sessions, case studies and key themes to be addressed at the American Biomanufacturing Summit 2016!