ABOUT SINGOTA SOLUTIONS
Singota Solutions is a Contract Development and Manufacturing Organization (CDMO) focused on moving products through the drug development pipeline faster—with agility, accountability, and transparency. Our goal is to collaborate with our clients and provide customized services to meet their needs and hit their milestones faster.
Our gloveless, robotic aseptic filling workcell provides a state-of-the-art filling process for manufacturing injectable therapies into vials, syringes, or cartridges. Advantages of our aseptic filling service include rapid access to our line with standard, ready-to-use components and the potential to reduce line losses as compared to traditional manufacturing capabilities. Singota also provides customized solutions for formulation development, supply chain/materials management, analytical testing, and finishing services.
Singota’s shorter lead times, dedicated team of experts, and single site location mean your project will receive focus and speed while never compromising quality, whether you are a virtual or large pharmaceutical company.
Challenges And Solutions In Biologics Finished Product Manufacturing
Development of biologic therapies can present a number of unique challenges for formulation scientists and process engineers. Issues such as the stability of the biologic material in a solution state must be considered along with the overall practicality of a formulation in terms of manufacturing, storage, transport, and administration.
Analytical Instrumentation – Advancing And Maintaining A CDMO’s Capabilities
CDMOs in the pharmaceutical/biotech industry rely heavily on state-of-the-art instrumentation to bring their client’s products from drug development through drug manufacturing to the patient. To better serve their client’s needs as technology and the pharmaceutical industry advances, a CDMO must know when to acquire new and emerging technologies, increase their overall instrument capacity, and continually maintain their existing validated instrumentation.
Strategies To Maximize Batch Yields In Aseptic Manufacturing
Active ingredients have become increasingly complex and costly to manufacture. This paper outlines strategies aseptic drug manufacturers can adopt to maximize the final yield of their products.
The Dating Game – Trust & Compatibility In Outsourcing Partnerships
By doing your due diligence in selecting an appropriate outsourcing partner, some of the challenges can be turned into planned objectives as you move closer to (hopefully) positive results in the clinic. Pre-selecting a contract development and manufacturing organization (CDMO) based on not only capabilities but compatibility and trust will help throughout the journey.
Simplifying Aseptic Contract Manufacturing – Part 2: Documentation
Explore the impacts of a fully integrated filler/isolator system with built-in decontamination technology operating principles, which combine to radically reduce and simplify manufacturing documentation.
Rethink Aseptic Filling To Meet Pharma’s Challenging Requirements
Batch sizes required to manufacture therapies have grown smaller since the days of blockbuster medicines, challenging smaller pharma companies to change equipment and manufacturing processes.
Understand Your Process: A Key To CMO Risk Mitigation
Inadequate communication and knowledge transfer between the originator and the CMO creates risk. This paper covers methods to reduce risks when moving from the lab to a GMP manufacturing setting.
Approach To Simplifying Aseptic Contract Manufacturing
This article addresses some of the challenges and solutions available to pharma/biotech companies and their supply chain partners to ensure critical clinical supply materials are ready when needed.
Truly “Focused on Faster” For Aseptic Filling
A small, research-focused biotech received positive results in the clinic for its current program. It needed urgent help getting clinical supplies to its distributor to make it in the clinic by January 2020.
5 Keys To Avoid Drug Development Delays When Using CDMOs
Dealing with CDMOs can be a daunting task for some drug developers. Here are five key factors to keep in mind when trying to troubleshoot drug development delays by selecting the right partner.
5 Qualifying Questions To Evaluate Solution Providers For Temperature-Controlled Shipping
Life sciences companies with complex warehousing and shipping requirements have a lot of questions. Here are the questions to ask to identify a logistics vendor with the right competency.
3 Steps To Determine Need For A Shipping Lane Qualification
Learn how to perform various risk assessments to adequately determine the level of control required to ensure the safe transport of products throughout the pharmaceutical supply chain.
3 Steps To Strengthen Your Supply Chain Partnerships
If you’re struggling to achieve legitimate value, take advantage of this 3-step process to strengthen your supply chain partnerships.
Real-Time Monitoring Of Pharmaceutical Shipments
Supply chain visibility is paramount, but what criteria should be considered when evaluating monitoring devices whose data can be accessed from the provider’s software platform in real-time?
Characterizing Novel Microparticle-Encapsulated Drug Formulations
Once you have successfully encapsulated an (API), the next task is to characterize that product and understand its release kinetics, such that it can be labeled and prepared for subsequent studies. Following are some lessons learned from characterizing the end product.
Considerations For Formulating Microparticle-Encapsulated Drugs — Part 1
The emulsion system created when forming microparticle can quickly become complex. Following are critical factors to consider when beginning work with microparticle formulation for a large protein molecule.
Advantages Of A Cross-Functional Staff Model In Pharma Manufacturing
When an employee performs a wide range of manufacturing tasks, both in and beyond his or her comfort zone, there is less likelihood of burnout.
Microbiology Fills QC Role At A CDMO In Aseptic Filling And Sampling
Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow client access to data.
Singota Solutions—Focused On Faster
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.