Pace Analytical Life Sciences provides clients with a comprehensive range of analytical services to support the validation of pharmaceutical facilities. Our analytical testing services provide support for the validation of purified water systems, clean steam systems, compressed gases and clean rooms. We can help our clients’ commission new facilities, perform on-going qualification services as well […]
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The test, according to USP <55>, is designed to support sterilization testing, sterilization validation, sterilization monitoring, steam sterilization effectiveness, ethylene oxide (EO) sterilization effectiveness, sterility cycle lethality, along with lot release for compliance with testing requirements. The test consists of spore strips impregnated with several organisms’ spores and then subjected to the client’s sterilization process.
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Pace Analytical® Life Sciences (PLS) provides particulate matter testing (total particulate counts) for the pharmaceutical, biopharmaceutical and medical device industries. Particulate analysis follows the guidance of USP general chapters <787>, <788>, and <789>. These methods include procedures for counting, by size range the particulate contamination within the sample analyzed. We are experienced with a wide
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Microbial Limits Tests (MLT) performed by Pace Analytical Life Sciences (PLS) meet the requirements of the United States Pharmacopoeia (USP) general chapters <60>, <61>, and <62>, and in harmonization with the requirements of European Pharmacopoeia (EP) general chapters 2.6.12 and 2.6.13. PLS has expertise in a wide range of raw materials and product dosage forms.
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Summary: In an effort to improve stability and shelf life of a drug, the active ingredients in many therapeutics are typically mixed with a number of other inactive chemicals. The end result of this process, called formulation, is commonly a liquid solution or suspension. However, for certain drugs, which are prone to degradation or aggregation,
On-Demand Webinar Lyophilized Drug Product Development Read More »
Thursday, October 15, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST Event Overview: Determining the polymorphism of a drug—the propensity of a molecule to crystallize in different crystalline arrangements, to form crystalline salts and/or non-salt cocrystals—allows for rational selection of the proper solid form/polymorph for further development. In this webcast, learn about the
Live Webcast: Understanding Polymorphism to De-Risk Drug Development Read More »
ON DEMAND WEBINAR: Pharmaceutical Development of Oligonucleotides Oligonucleotides are an emerging class of DNA and RNA therapeutics that address a number of unmet medical needs. As with many biopharmaceuticals, the complex structure of oligonucleotides makes their large-scale synthesis both challenging and imperfect. A number of impurities are generated during manufacturing, many of which are hard
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Life Sciences We provide timely and accurate drug development and commercialization services from our U.S. owned and operated CDMO/CRO network. improving our health We believe the therapies our customers develop are critical to improving lives and we are proud to be a part. Pace® Life Sciences Hosts Grand Opening of its Center of Excellence for
Check out Nishan Shah, Ph.D’s publication in AAPS News Magazine! Read More…
ON DEMAND WEBINAR: Integrated CMC Development of Gene Therapies Therapeutics that manipulate gene expression are a rapidly growing segment of biopharmaceuticals that address unmet medical needs. However, gene therapies usually include both nucleic acid and protein components, exponentially increasing the complexity of the development tasks needed to meet the Chemistry, Manufacturing, and Control (CMC) requirements
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