Every pharmaceutical company is under pressure to monitor the changes that are taking place in the regulated landscape and respond to them accordingly. Regulatory intelligence activities include collecting, evaluating, and analyzing various pieces of information to position your company for success.
- Model-Based Control In Continuous Biomanufacturing
- The 2 Emerging Fields Propelling The Use Of AI In Precision Medicine
- Can Real-World Evidence Transform Healthcare? FDA Indicates Yes
- Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry
- Demystifying Blockchain-Supported Smart Contracts
- Juno v. Kite Case Implications For Functionally Claimed Biological Compositions
- Model-Based Control In Continuous Manufacturing of Biotherapeutics
Model-Based Control In Continuous Biomanufacturing
In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved product quality, lower capital cost, and easy scale-up. The primary focus lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address dynamic conditions.
The 2 Emerging Fields Propelling The Use Of AI In Precision Medicine
Advances in AI-based analysis paradigms have created an unprecedented momentum in computational medical imaging applications, giving rise to new areas of precision medicine research. This article examines how recent medical imaging advances in oncology are bringing about new areas of precision medicine and previews its full potential.
Can Real-World Evidence Transform Healthcare? FDA Indicates Yes
Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.
Solving The 4 Serialization Challenges Of Track & Trace In The Biopharma Industry
More than 10 years after introducing track and trace, the pharmaceutical industry still faces a number of technical challenges and limitations related to regulatory expectations, with many companies still transforming their packaging operations to meet them.
Demystifying Blockchain-Supported Smart Contracts
Promising increased accuracy, transparency, and security, smart contracts and blockchain technology are the next steps in the evolution of secure data transaction. Companies in the pharmaceutical industry, and their supply chains, will be forced to adapt their operations to keep up with these generational changes in order to competitively deliver services and treatments.
Juno v. Kite Case Implications For Functionally Claimed Biological Compositions
The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?
Model-Based Control In Continuous Manufacturing of Biotherapeutics
During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.
Opportunities For Implantable Drug Delivery To Modernize Drug Therapy
The implantable drug delivery system allows targeted and localized drug delivery for achieving an optimum therapeutic effect. This article examines the clinical significance of implantable drug delivery systems as well as opportunities that can be leveraged by drug therapy developers in meeting global health needs, particularly in the areas of women's health, cancer treatment, and ocular disease treatment.
PHARMA ONLINE WHITE PAPERS
Organoids: Ideal Model Systems For Disease And Drug Screening?
Successful organoid formation is dependent on many factors, all of which are crucial in fulfilling the potential of this powerful new tool for personalized medicine.
Tumor-Infiltrating Lymphocytes: What, Why, And How7/1/2020
As we explore immune mechanisms using technology, we find better ways to fight disease. Here, we focus on targeted, highly personalized cancer therapies called tumor-infiltrating lymphocytes.
Standardizing Vein-To-Vein Logistics To Reach More Patients2/24/2020
Collaboration is key to solving data management and process variability challenges as stakeholders work towards a common goal—getting life-saving treatments to those who need them.
Best Practices For Biopharmaceutical Technology Transfer: Facility Fit And Process Gap Assessments11/3/2020
During the drug discovery journey, technology transfer is an intrinsic part of the successful development, manufacturing, and commercialization of a product. Biopharmaceutical technology transfer requires careful planning and evaluation to meet project timelines for scale up and GMP manufacture.
Novel Platform Enables Creation Of ASD Solid Dosage Forms With High Drug Loadings6/1/2020
The prevalence of active compounds with low aqueous solubility exceeds 70% in drug pipelines, preventing the development of many compounds as effective medicines. A novel formulation platform makes it possible to meet the requirements for a successful high-loading spray-dried amorphous solid dispersion (ASD) dosage form, reducing tablet mass by nearly half to meet patient needs.
Analysis Of Laboratory Nitrile Gloves: From Pores To The Surface10/7/2020
The humble rubber glove is usually the first line of protection for any person working with toxic, hazardous and contagious materials or environments. While everyone agrees on their universal use, very little attention is paid to the type of material, surface topography or pore size distribution of the glove itself. Here we describe an approach where the use of multiple techniques has enabled a complete physical characterization of the rubber glove material.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Our latest e-book explores efforts to pay closer attention to how your company’s culture and operations ensure the completeness, consistency, and accuracy of data - AKA data integrity. Such data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), according to the FDA. Similarly, data must be complete, consistent, and accurate throughout the data life cycle, according to the MHRA and the Pharmaceutical Inspection Co-operation Scheme.More Content Collections
PHARMA ONLINE PRODUCTS & SERVICES
LIFE SCIENCE CONNECT SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.