Jacob Wheeler Best Practices, Development, Industry, Innovation, Manufacturing, Production

Specializing In Small And Early-Stage Partners, Not Just Small Batches

Source: Singota SolutionsBy Jennifer Gray and Eric Graban, Singota SolutionsFor small and/or earlier-stage pharmaceutical companies trying to advance a small-volume drug product through preclinical and clinical trials, the temptation to partner with large, well-known CDMOs for aseptic manufacturing can be alluring. Their reputation as service providers for large pharmaceutical companies, along with their…
Read More
sample scoop active
Jacob Wheeler Development, Industry, Innovation

How A Sample/Dispense Service Streamlines Drug Development

Source: Singota Solutions By Alice Levis, Singota Solutions Biopharma organizations 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…
Read More
cold chain
Jacob Wheeler Development, Industry, Innovation, Supply Chain Management

Evaluation And Management Of Vendor-Qualified Thermal Solutions

Source: Singota Solutions By Travis Hudson, Singota 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…
Read More
Michelle Hoover Industry, Manufacturing, Quality Assurance, Testing

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

Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies Source: Singota Solutions By Ken Chomistek, Singota Solutions 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. Peptides, proteins, monoclonal antibodies, oligonucleotides,…
Read More
Jacob Wheeler Industry, Manufacturing, Quality Assurance

Expertise And Efficiency In Small-Volume Batch Manufacturing

Expertise And Efficiency In Small-Volume Batch Manufacturing Source: Singota Solutions By Alex Cravens, Singota Solutions Demand for small-batch drug product (DP) 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…
Read More
Site Admin Industry, 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…
Read More
Remote Audits
Site Admin Best Practices, Industry

Establishing a Remote Audit Process as a CDMO

The effects of the pandemic have been far reaching within the pharmaceutical industry and compliance audits have not been immune. Widespread travel restrictions and adjusted visitor policies have prevented standard onsite audits from occurring. As a CDMO, Singota had to pivot to provide clients with transparent and robust compliance audits. This article will dive into the process of establishing a remote audit process and how Singota implemented various changes to acclimate to the new norm.

Read More

Posts navigation

1 2