White Paper: Particle Works
The development of nanoparticles (NPs) as drug carriers for specific action sites has gained significant attention in recent times. However, the synthesis of NPs for drug delivery is complex and challenging, and therefore requires consistent, low-cost, and efficient materials. Particle Works offers NP synthesis solutions that are underpinned by microfluidics and automation, enabling researchers to accelerate their nanomedicine development. The Automated Nanoparticle (ANP) System provides both automated process optimization and continuous manufacturing capabilities on a single platform. This system allows scientists to automatically optimize process parameters and generate test samples. Particle Works offers the ALiS System for screening low volumes of various formulations in a 96-well plate format, while the ANP System is used to optimize the size, shape and structure of NPs ahead of final production and commercialization. The ANP System can be used initially in ’protocol mode’, where the system can sequentially execute a table of automated and low volume experiments from a fixed pair of injected reagents. Using the Flow Control Centre (FCC) software, users can optimize the flow rate ratio (FRR), total flow rate (TFR), NP precursor volume, sample collection volume, and select optional in-line dilution. Once a desired set of experimental conditions has been identified, the user can then switch to ‘continuous mode’ to create liters of NPs for pre-clinical trials and extensive characterization. Unique in this dual capability, the ANP System bridges the gap between formulation screening and commercial scale manufacturing in a single system solution.
White Paper: Altmetric
Identifying and nurturing Digital Opinion Leaders (DOLs) has become as critical as the role of Key Opinion Leaders (KOLs) in increasing ‘share of voice’ in the market. Medical affairs and publication planning teams have traditionally been responsible for increasing ‘share of voice, usually by reaching out to Key Opinion Leaders (KOLs). While this hasn’t changed, who you need to reach - and how - has. The influence of KOLs remains important, but tends to be focused on ‘offline’ activities. Meanwhile, Digital Opinion Leaders (DOLs) have gained more power to influence the groups that matter to pharmaceutical companies, with a much wider social reach than KOLs. Digital Opinion Leaders are driving health policy decisions, and even shaping brands before a product has launched by: Initiating online conversations Reviewing opinions Responding to comments Exerting influence over peers, patients and others in the industry We estimate that there is currently only a 10 percent overlap between KOLs and DOLs. This is because in general they have presence in different spheres with different audiences. To engage DOLs, medical affairs and publication planning teams must learn what topics a DOL is passionate about, what channels they engage with and what information they are asking for. In Altmetric's latest report 'Building a bigger picture: the Altmetric advantage' we examine:': The rise of the Digital Opinion Leader How to measure share of voice in a digital age How to measure value and maximise research Tracking and measuring conversations on digital platforms is vital to measuring your brand’s influence. Find out how you can get better insights into the broader societal impacts of your research and products, including how they’re received and the demographics engaging with them. Download now
White Paper: DelNova
What are the complications associated with Botulinum Neurotoxin therapies? Neurotoxins are administered by medical professionals and sold in the US under the brand names Botox®, Dysport®, Xeomin® and most recently Jeaveau®. These are all important and relevant questions. Learn about the risks in this whitespace. What is the clinical evidence? Does this issue impact consumer/patient adoption of these therapies? Learn more about risks, in cosmetic/medical aesthetic procedures, as well as therapeutic indications.
How to Not Fail an Inspection
White Paper: MasterControl
Overcoming Pharma’s Top 6 Quality and Compliance Oversights Benefits of Platform Integration and Iterative Task Automation For companies doing business in the heavily regulated pharmaceutical industry, quality management and compliance are not just intimidating endeavors — they involve activities that are increasing in complexity as the industry accelerates. Quality successes can only be achieved in the modern regulatory environment when an extensive range of variables are continually monitored and appropriately handled. The prevention of quality oversights — whether they occur during document control activities, corrective action/preventive action (CAPA) management, audit initiatives, supplier relationships, or any other quality-related process — demands precise actions, informed decision-making, and connected processes, all of which can only be realistically achieved in accordance with regulatory requirements by using purpose-built digital solutions. Avoiding Quality and Compliance Oversights This brief presents six common quality and compliance missteps that pharma companies either inadvertently enable or unknowingly perpetuate over time. It also recommends actions organizations can take today to help mitigate the long-and short-term problems caused by each oversight. Oversight #1: Failure to Adapt to Regulators’ Risk-Based Approach to Quality Over the past decade, the regulations and standards that affect pharmaceutical companies have been trending toward a greater focus on risk management and risk-based thinking, a shift that has undoubtedly been accelerated by the COVID-19 pandemic. With each update to an existing standard or new regulation that goes into effect, regulatory agencies are placing more emphasis on risk management and mitigation. Regulators across the globe are shifting from what was once a one-size-fits-all regulatory mentality to a more segmented approach that is primarily driven by data. This compliance trend is expected to become more prevalent, as indicated by the U.S. Food and Drug Administration (FDA) Q9 Quality Risk Management guidance which specifies that greater assurance of a company’s ability to deal with potential risks “might affect the extent and level of direct regulatory oversight.”i As the role of good quality data (and auditors’ access to it) becomes increasingly vital to the enforcement of regulatory policies, effective risk management is emerging as the cornerstone of compliance. But risk-based quality management isn’t just important for compliance reasons — it is essential for neutralizing the effects (and potential effects) of quality events that commonly occur in pharma environments.
Implementing a Serialization Project Post DSCSA
White Paper: DMLogic
Implementing a Serialization Project Post DSCSA With growing concern surrounding the integrity of the pharmaceutical supply chain, many companies have chosen to implement serialization method to prevent counterfeit drugs from reaching market.To conform with the new DSCSA, manufacturers are making an investment in the systems, equipment and processes to ensure that their drugs are serialized at every stage of the supply chain. The only way to counteract the distribution of falsified medicines is the reliable serialization and labeling systems of pharmaceutical products that can put an end to the very serious global trade in illegal drugs. This whitepaper gives you insights on overcoming the practical challenges of pharmaceutical serialization, best practice deployment and achieving business benefits. Download the guide now to discover: How serialization will address issues in the integrity of the supply chain? How reliable serialization and labeling systems of pharmaceutical products can put an end to the very serious global trade in illegal drugs? Understand how serialization will affect operations? What are the challenges of serialization?
Track and Trace in the Pharmaceutical Industry
White Paper: Gep
The pharmaceutical industry is not short of challenges — patent cliffs, regulatory scrutiny, and R&D productivity, as well as a complex supply chain. Pharmaceutical products see several changes of hands — from the manufacturers to distributors to dispensers and, finally, the patients — allowing easy entry of counterfeit drugs and drug diversions. According to estimates by the WHO, nearly $40 billion is lost each year to counterfeit products.