Rethinking Aseptic Filling: Innovations To Meet Pharma’s Challenging Requirements

In the dynamic landscape of drug development, the focus has shifted towards therapies tailored to smaller patient populations, necessitating adjustments in manufacturing approaches. This trend, fueled by the rise of therapies for rare diseases and the targeting of specific patient subsets, poses unique challenges for pharmaceutical companies, particularly in navigating…

Microbiology Fulfills A Vital QC Role At A CDMO In Aseptic Filling And Sampling

In the dynamic landscape of pharmaceutical manufacturing, where precision and compliance are paramount, every step in the process plays a critical role in ensuring product efficacy and safety. From the meticulous development of injectable formulations to the stringent requirements of cold chain pharmaceutical storage, each phase demands meticulous attention to…

How Efficient Batch Records Serve Thorough Tech Transfer — Optimizing Aseptic Fill For Development Projects

As the pharmaceutical industry continues to advance, the need for efficient and effective technology transfer processes becomes increasingly crucial. From small batch aseptic filler, to cold chain pharmaceutical storage, companies are constantly seeking aseptic manufacturing solutions, preferably with GMP compliant warehouse facilities, to streamline injectable formulation development. However, the intricate…

Approach To Simplifying Aseptic Contract Manufacturing – Part 2: Documentation

In our ongoing exploration of aseptic manufacturing solutions, this second installment delves deeper into the operational efficiencies brought forth by the Cytiva SA25 Aseptic Filling Workcell, utilized by Singota Solutions (the very first in North America to employ the SA25). This installment focuses on how this state-of-the-art small batch aseptic…

Approach To Simplifying Aseptic Contract Manufacturing

Navigating the intricacies of pharmaceutical and biologic clinical trials demands agile supply chain management, especially when facing sudden demands for clinical drug product. In this inaugural piece of our series, we delve into the pivotal role of Contract Development and Manufacturing Organizations like Singota Solutions (Bloomington, Indiana CDMO) in meeting…

Advancing Aseptic Filling: Evaluating The Revolutionary SA25 Workcell

In the ever-evolving landscape of injectable formulation development, aseptic filling, and aseptic manufacturing solutions, the SA25 Workcell, a groundbreaking innovation crafted by Vanrx (now Cytiva) that Singota Solution's (CDMO in Bloomington, Indiana) pioneered in North America, emerges as a beacon of progress. This state-of-the-art technology represents a significant leap in…

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:

Singota Solutions Adds World-Class Sterile Aseptic Filling Technology

Singota Solutions, a life sciences contract service provider, brings new technology to the U.S. with its sterile filling expansion. BLOOMINGTON, INDIANA (PRWEB) FEBRUARY 28, 2017 Singota Solutions announced it has completed installation of the pharmaceutical industry’s most advanced manufacturing technology for use in filling injectable drug products into vials, syringes, and…