Among the many things that the COVID-19 pandemic brought to light, life science organizations were faced with the immediate need to improve the reliability, safety, scalability, and speed to market of their offerings. This much is clear: Gone are the days of using inefficient, cumbersome paper procedures and disconnected systems. Today’s complex manufacturing organizations are under great pressure to simultaneously speed up their processes while ensuring top quality. In order to meet today’s demands, the adoption of intelligent technology and remote collaboration platforms is crucial—empowering organizations to efficiently connect their people, processes, and environments. Through leveraging intelligent technology and Pharma 4.0 connected systems, organizations are able to: Connect, monitor, and support their various teams in real-time Significantly improve batch yield Effectively manage resources Utilize guided workflow assistance Gather, query, and store the critical data needed to improve efficiency, reliability, compliance, and speed Learn more in this exclusive Apprentice e-book:
Read More →Examining Long-Term Storage Requirements & Needs of Biologicals
As we ramp up for the 2020 American Biomanufacturing Summit, we’re excited to share this exclusive e-book created for PHC Corporation of North America, one of our Silver Partners. In this e-book, we examine the long-term storage requirements and needs of biologicals. Here’s a key excerpt from our interview with PHC Corporation of North America: “As cell-based therapies and pharmaceuticals continue to proliferate in the market, the demand for precision cold storage will be vital to maintain medicinal efficacy and research sample viability. PHCbi refrigerators, freezers, and cryogenic products represent over fifty years of engineering excellence in temperature-controlled products. From the refrigeration platform to the control center and cabinet configuration, each model was purpose-built for the safety and viability of high-value pharmaceuticals and biologics.” Check out the full e-book here. Don’t miss out on PHCbi’s roundtable discussion at the American Biomanufacturing Summit (July 22nd @1:10PM EST) led by Carl Radosevich, Senior Manager of Scientific Applications and Collaborations. You can click here to view the full program.
Read More →UQUIFA SHARES THEIR INSIGHTS ON OLEFIN METATHESIS
With over 80 years of experience, UQUIFA’s business model is based on a combination of a quality manufacturing platform and a track record of service and reliability. They have four manufacturing sites (two in Spain, one in Hungary and one in Mexico) with strict adherence to all regulatory norms. These sites operate under cGMP conditions and have been inspected and approved by leading global pharmaceutical companies and regulatory authorities, including the USFDA.
Read More →American Biomanufacturing Summit Gathers Executives to Discuss the Right Tools, Mindset and Culture Needed to Drive Productivity and Ingenuity
From June 18-19, biopharmaceutical executives and cutting-edge technology providers are meeting in San Fransisco to discuss industry challenges and opportunities, quality as a culture, supply chain management, and new technologies.
Read More →CMO and Pharmaceutical Company Relationships: What is the Client’s Role?
Over the last 25 years, contract manufacturing organizations (CMOs) have played an increasingly important role in the pharmaceutical industry. The need to decrease time to market, improve process efficiency, and reduce costs are all crucial reasons why pharma companies have an increasing use for CMOs – and they’re the same key factors that have propelled the growth of the outsourcing market and will continue to propel its growth over the coming years. A November 2016 study from Industry Standard Research Reports reveals that life sciences companies now outsource two-thirds of their manufacturing activities for CMOs. For small to mid-sized companies – where outsourcing manufacturing isn’t just a convenience, it’s a necessity – that figure is even higher: up to 80% in 2015. These partnerships often last many years and have the potential to either constrict or add considerable value to a company’es growth. Success relies, of course, on choosing the right manufacturer. But once the contract is signed, what are the responsibilities of the client to ensure effective collaboration and maximum productivity? Recognizing how the relationship can break down on the client’s side is a crucial step in reducing risks.
Read More →The Importance of Customer Service in Pharmaceutical Contract Manufacturing
With tightening regulations and rising costs, the pharmaceutical industry is being presented with a consistent challenge in the marketplace: Do more with less. As a result, pharma companies are reducing their internal capacities in manufacturing and R&D and are, instead, increasing their outsourcing. More than ever, these companies are relying on external service providers to fulfill their manufacturing needs and improve their productivity. In 2016, a study from Industry Standard Research Reports revealed that life sciences companies now outsource two-thirds of their manufacturing activities to CMOs. That figure is even higher for small and mid-sized companies: up to 80% in 2015.
Read More →The Effects of Customer Service and Effective Supplier Communication on the CMO-Client Relationship
Q&A with Aphena Pharma Solutions The future of outsourcing is brighter than ever as pharmaceutical companies continue to rely on contract manufacturing organizations (CMOs) for their manufacturing needs. This move allows pharma companies to focus on their core business, especially marketing and R&D, which can reduce costs, cut down time-to-market, and increase bottom line, while relying on external manufacturing experts to provide fast and cost-effective drug development. But in a time when two-thirds of pharmaceutical manufacturing is outsourced, price, quality and capability rarely separate the players in the market. Instead, what differentiates the competition is service. Pharmaceutical companies and CMOs are increasingly evolving their relationship from one-dimensional product outsourcing into comprehensive partnerships that center around one major theme: customer service. Following the American Pharma Outsourcing Summit 2018, we spoke with Eric Allen, Executive VP of Sales & Marketing; Bob Scott, President of Operations; and Paul Glintenkamp, Director of Business Development at Aphena Pharma Solutions to address the effects of good customer service and effective supplier communication on operations and outcomes, and to help pharmaceutical companies and CMOs get the most out of their manufacturing relationship.
Read More →Track and Trace: A Step-by-Step Guide to Implementing An Effective Program
Although the universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply chain integrity to the public. While several states are actively pursuing similar legislation, California’s pending requirements are the most demanding since they track product to the smallest saleable unit level. Enforcement of the ePedigree legislation, combined with the accelerated pace of regulatory involvement worldwide in serialization and track-and-trace means that it is now vital for the industry to accelerate its efforts to put compliance measures in place.
Read More →Serialization: Optimizing Planning and Implementation
Increased globalization in the supply chain for prescription drugs has also increased the distribution of counterfeit drugs. To combat this problem in the U.S., the FDA has outlined requirements to make every unit of saleable prescription drug products traceable. Meeting the requirements for these regulations requires a long-term strategy and preparation. Recro Gainesville, understanding the changing manufacturing landscape, began this process years in advance. Product serialization enables manufacturers and distributors to protect consumers from potentially harmful counterfeit and stolen drug products by improving supply chain tracking, visibility and management.
Read More →How to Avoid Data Integrity Disasters in Your Manufacturing Network
Lachman Consultants says that pharmaceutical manufacturers can establish a competitive advantage by preventing questions about their product quality data from disrupting current and future revenue. In recent years, data integrity shortcomings identified during GMP inspections have cost firms dearly. In some cases, the financial impact has run into the hundreds of millions of dollars. Despite the risk, many manufacturers do not seek help with data integrity compliance until there is a problem. By then, it may be too late to avoid an impact on profitability. For this reason, Lachman Consultants urges pharmaceutical companies to establish a competitive advantage by taking a proactive approach to data integrity assurance.
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