manufacturing -

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.

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 11, 2022October 30, 2024

IND Submission DMO Singota Solutions (Bloomington, Indiana), a leader in Sterile Aseptic Filling, discusses Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies. Singota specializes in small batch aseptic filler, aseptic manufacturing solutions, cold chain pharmaceutical storage, gmp compliant warehouse, and injectable formulation development.

Michelle Hoover Best Practices, Manufacturing

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies

Microbial challenge studies are becoming increasingly common as drug products (DP) are being manufactured with different types of active pharmaceutical ingredients (API) than fifteen years ago (IND Submission). Peptides, proteins, monoclonal antibodies, oligonucleotides, and biosimilars are more common; manufacturing no longer places an emphasis on small molecules. These new APIs…

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…

February 16, 2022October 30, 2024

Site Admin Best Practices, Quality Assurance, Testing

Which Testing Does An Effective Certificate Of Analysis Include?

Source: Singota Solutions By Ken Chomistek, Singota Solutions Compendial monograph (pharmacopeial) testing applied to pharmaceutical raw materials and finished drug products is a critical element of drug development. A testing record is created in the form of a Certificate of Analysis (CoA) for manufacturing release and distribution. However, the testing required…

January 4, 2022April 26, 2024

William Powers Aseptic Filling, Manufacturing

Scheduling Aseptic Filling for Preclinical and Clinical Batches

A biopharmaceutical sponsor's selection of a CDMO partner is a matter of finding the appropriate partner for a particular job. While a prospective partner’s qualifications may appear acceptable on paper, its company culture, the priority it places on a client’s project, or its availability to schedule client aseptic filling runs…

August 31, 2021October 25, 2024

Site Admin Best Practices, Supply Chain Management

Establishing a Successful Supply Chain for High Value Products

Establishing a Successful Supply Chain for High Value Products Two of the greatest risks in high value BioPharma supply chains are the product adulteration during transport and non-compliance with regulations, guidelines and standards. After that, an important concern of manufacturers and distributors is cost containment in an increasingly globalized and…

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