Jacob Wheeler - Singota Solutions

August 15, 2023October 30, 2024

Aseptic Filling CDMO Singota Solutions in Bloomington, Indiana, discusses Creating Accurate, Efficient, And Effective CDMO Drug Development Project Proposals. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.

Creating Accurate, Efficient, And Effective CDMO Project Proposals

Project proposals are among the first steps in the partnership between a pharmaceutical company and a CDMO. The project proposal is critical to defining project scope and goals. Most of the information in the proposal is based on a questionnaire from the CDMO but can also be obtained from a…

June 13, 2023October 24, 2024

Aseptic Filling CDMO Singota Solutions, in Bloomington, Indiana specializing in small batch aseptic filler aseptic manufacturing solutions cold chain pharmaceutical storage gmp compliant warehouse injectable formulation development, discusses Formulation Development For Injectables With Captisol®. Singota Solutions specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.

Jacob Wheeler Development

Parenteral Formulation Development With Captisol®

Source: Singota Solutions Singota has conducted formulation development projects for its clients over the years, several of them requiring solutions and improvements to aid in solubility and drug stability performance. During the course of these projects, the use of Ligand’s Captisol® technology has emerged as an important tool in achieving…

April 24, 2023October 30, 2024

Aseptic Filling CDMO Singota Solutions (Bloomington, Indiana) discusses Deliver A Technical Package That Serves On-Time Injectable Project Completion. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.

Jacob Wheeler Best Practices

Deliver A Technical Package That Serves On-Time Injectable Project Completion

Meeting drug development timelines — in particular, filling the first Phase 1 batch for an injectable’s clinical trial – is critical. Producing that initial batch requires the CDMO to gather information from a pharmaceutical client about its drug substance, drug product, and analytical methods (technical package). If the information is…

March 31, 2023October 30, 2024

Jacob Wheeler Best Practices, Development, Quality Assurance, Testing

Analysis Paralysis: Navigating Early-Phase Analytical Validation

Significant confusion persists across the pharmaceutical/biopharmaceutical industry relevant to early-phase analytical development and analytical validation. While several guidance documents serve as a de facto standard, distinguishing method validation requirements from suggestions, when and how to apply those guidelines often is not a straightforward task.It is critical to establish a product/project’s…

November 15, 2022October 30, 2024

Jacob Wheeler Best Practices

Keys To Successful Blinded Labeling

Blinded labeling is an essential element in all clinical trials. To remove the risk of bias, active pharmaceutical ingredient (API) drugs, delivery apparatus, and kits must be visually indistinguishable from placebo units — including their respective labels. The content and creation of these labels, though, is tightly regulated and benefits…

October 27, 2022October 30, 2024

Drug Development Singota Solutions Aseptic Filling CDMO in Bloomington, Indiana, discusses how to sample/dispense service streamlines drug development. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.

Jacob Wheeler Development

How A Sample/Dispense Service Streamlines Drug Development

Biopharma organizations in drug development (like Singota Solutions) often require aliquoting of materials to support their projects, but can be burdened by the timelines, costs, and risk of compromising materials. Not all contract development and manufacturing organizations (CDMOs) have the capability to aliquot clients' material via sample (non-GMP use) and…

October 27, 2022October 30, 2024

Thermal Solutions CDMO Singota Solutions (Bloomington, Indiana), an industry leader in Aseptic Filling, discusses Evaluation And Management Of Vendor-Qualified Thermal Solutions. Singota specializes in small batch aseptic filler aseptic manufacturing solutions cold chain pharmaceutical storage gmp compliant warehouse injectable formulation development.

Jacob Wheeler Best Practices

Evaluation And Management Of Vendor-Qualified Thermal Solutions

Evaluating vendor qualification of thermal solutions is not an indictment of the vendor; it is due diligence in an industry where risk guides nearly all decision-making, as well as many regulatory mandates. Usage of a system can be justified based on a vendor’s qualification in many cases, but no single model…

July 8, 2022October 30, 2024

Batch Manufacturing CDMO Singota Solutions (Bloomington, Indiana), a leading Aseptic Filling provider, discusses Expertise And Efficiency In Small-Volume Batch Manufacturing. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.

Jacob Wheeler Manufacturing

Expertise And Efficiency In Small-Volume Batch Manufacturing

Demand for small-volume drug product (DP) batch manufacturing — from formulation to sterile fill/finish — is rising as drugs for precision medicine and large-molecule biologics gain in prominence. However, traditional fill/finish providers may consider small batch sizes as lacking economic feasibility. They may offer only rigid, far-in-the-future manufacturing dates or…