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…

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…

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…

Strategies to Maximize Batch Yields in Aseptic Manufacturing: High Value Actives

Advances in drug and biologics discovery have allowed the development of increasingly sophisticated and highly targeted therapeutics. The active ingredients, whether small molecules or biologics, have become increasingly complex and costly to manufacture. Because of the physical properties of most biologics, the route of administration is typically parenteral and therefore it is imperative that manufacturers of sterile drug product develop strategies to maximize their yields and minimize losses throughout the finished product production process. Here are a number of considerations: