CMC Pharmaceuticals Announces Additions to its cGMP Lab Services
Starting on Oct. 1, 2019, CMC Pharmaceuticals will focus on upgrading laboratory SOPs and documentation practices to comply with FDA guidelines.
CMC Pharmaceuticals, a pharmaceutical and biotechnology drug product development services and manufacturing support company, announced additions to its Solon, OH, good manufacturing practices (cGMP) lab services starting on Oct. 1, 2019.
The addition will focus on upgrading laboratory SOPs and documentation practices to comply with FDA guidelines, according to a Sept. 10, 2019 press release. With the additions, data generated in the company’s laboratory may be included or used to support their contract customer’s filings with FDA when cGMP laboratory studies are required. The company can also develop or improve drug product formulations, prepare prototypes of a variety of dosage forms, conduct stability and material compatibility studies, and create or optimize analytical methods that are suitable for inclusion in their clients’ FDA submissions.
“We started this organization five years ago to help pharma and biotech companies develop robust drug products faster,'' said Mike Radomsky, founder and president of CMC Pharmaceuticals, in the press release. “This logical expansion of our service offering is in response to the expanding needs of our valued customers and allows us to directly support them with their submissions to the FDA.”
Source: CMC Pharmaceuticals
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
