Business Process Outsourcing
Create rich digital work instructions for better test method execution.
Managing documents, training, and business processes are nightmares shared by all pharmaceutical and biotech companies and MasterControl provides pharmaceutical quality management software systems to take them out from that nightmare. MasterControl's QMS software exchanges the nightmares for a dream of a solution that enables pharma companies get their products to market faster and improve compliance at the same time. MasterControl pharma QMS software has been specifically designed to help manage all documents and automate regulatory-related processes and training in a single platform.
Chain Of Compliance®: Collects, Interprets, And Leverages Comprehensive Data To Enable A Significantly Smarter Supply Chain
Companies vying to be the first to market with breakthrough treatments have a great deal riding on the success of their efforts. Incorporating innovative processes, ethical considerations, assuring the safety and efficacy of the product, and managing the commodity's environmental control are formidable challenges that often lack standardized quality control procedures. Precision medicine requires end-to-end traceability: everything from chain of custody, to chain of condition, to chain of identity. The fragility of regenerative medicine therapies and the need to manage risk means a fourth link in the chain will soon be a regulatory requirement.
Low - Medium Viscosities
< 100 cP
1 - 10 ml
High - Ultra-High Viscosities
>100 - 10,000 cP
0.5 - 3 ml
ArQ® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in less than 5 seconds. The ArQ-Bios platform also can deliver greater volumes than 1 ml subject to matching the formulation characteristics with acceptable patient tolerability.
Using Document Change Control Software in Regulated Environments
Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.
In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.
WHITE PAPERS AND CASE STUDIES
The Shift Toward US Pharmaceutical Manufacturing
The pandemic has brought the global interdependency of pharmaceutical supply chains into sharp focus, exposing weak links and re-igniting discussions around the value of reshoring production. Explore effective strategies to secure and de-risk pharmaceutical supply chains.
Using Replicate BIs To Evaluate Biodecontamination Cycles In Isolators
We discuss the concept of using triplicate biological indicators (BIs), not as a reaction to having obtained an unexpected growth-positive BI in your vaopr hydrogen peroxide cycle, but as a proactive measure.
4 Machine Learning Use Cases for Clinical Trials
Want to optimize your clinical documentation processes, promote effective TMF automation, and improve the overall process efficiency with machine learning (ML) technologies? Here are four business cases where ML can help you approach TMF documentation processes with greater efficiency, timeliness, and quality.
Cloning Cell Lines: A Comparison Of 3 Methods
Limiting dilution cloning (LDC) has been the standard for generating clonal cell lines. This case study compares methods, using different cell lines, to determine which delivers the most viable clones.
Navigating The Adoption Of Continuous Pharma Manufacturing
Driving a path forward for continuous manufacturing calls for a closer look at current global challenges, any existing barriers, and the ideas and initiatives necessary to fulfill its potential.
Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing
Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.
AIRe Link. Real-World Examples Based On Konica Minolta Remote Support Tools Usage.
Throughout 2021, the printer company Konica Minolta added AIRe Link as part of their remote-by-default strategy. As a result, Konica Minolta was able to test the remote visual support tools to see how it impacted their overall ability to support customers. This article will go through the benefits Konica Minolta noticed, in addition to highlighting use cases in which AIRe Link worked well to support both technicians and customers.
The Digitalization Of Biopharma Process Development, Manufacturing
The fourth industrial revolution is coming. Explore the three essentials of bioprocess development and manufacturing digitalization: digital literacy, digital trust, and prioritization.
FACS Bulk Enrichment In Combination With Cell Cloning Systems Delivers Significant Savings For A CDMO
Learn how the Cell Line Development (CLD) department at Celonic Ag was able to optimize their workflow with new technology geared towards shortening time lines and lightening workload.
End Of End Point Assays: SPR Analytics In Vaccine Design, Development
Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.
How To Ensure You Get Optimal Study Power For Your Investment In Time And Cost
Cytel’s new position paper takes trial sponsors through a step-by-step process for how to obtain this full set of optimized clinical trial designs.
Risk Assessment As A Process Quality Assurance Tool
Discover how an effective approach to risk management can further ensure delivery of a high quality drug or medicine to the patient.
Researchers Create Personalized Organoid Models For Rare Spinal Cancer2/16/2022
A new study adds to a growing body of evidence that organoids — lab-grown collections of cells that mimic a patient’s tumor — are a promising avenue for drug discovery to improve outcomes in patients with cancer, particularly rare cancers for which clinical data on drug effectiveness is often lacking.
Minerva Neurosciences Submits New Drug Application To FDA For Roluperidone For The Treatment Of Negative Symptoms In Patients With Schizophrenia8/22/2022
Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
New Chip-Based Beam Steering Device Lays Groundwork For Smaller, Cheaper Lidar8/4/2022
Researchers have developed a new chip-based OPA that solves many of the problems that have plagued OPAs. They show that the device can eliminate a key optical artifact known as aliasing, achieving beam steering over a large field of view while maintaining high beam quality, a combination that could greatly improve lidar systems.
Disarming Pathogens: New Drug Candidates To Combat Chronic Infections1/23/2023
The pathogen Pseudomonas aeruginosa is the cause of a large number of serious infections and places a particular burden on immunocompromised patients. The increasing spread of antimicrobial resistance makes it even more difficult to combat the dreaded hospital pathogen.
Biosimilars Forum Letter To Senate HELP Committee On FDA User Fee Agreements4/6/2022
The Biosimilars Forum submitted the following letter to the U.S. Senate Committee on Health, Education, Labor & Pensions in advance of the hearing FDA User Fee Agreements: Advancing Medical Product Regulation and Innovation for the Benefit of Patients.