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Pace Analytical Life Sciences’ GMP testing lab has been collaborating with clients to develop pharmaceutical, biopharmaceutical, and medical device products for over 20 years.

Pace Life Sciences provides full-service, extensive drug analysis capabilities with concomitant process understanding, by leveraging analytical methods, physicochemical, biophysical, and/or biopharmaceutical characterization. The combination of our team’s experience and our cutting edge, GMP, FDA approved facilities allows us to assist our clients to analyze their novel drug entities. Our customers also have access our secure laboratory data management system.  Click here to learn more.

PLS GMP

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Pharmaceutical GMP Testing

Pace provides our customers with a full-service, extensive small molecule analysis capabilities, by leveraging advanced analytical methods. The combination of Pace’s experience and cutting edge, GMP, FDA approved facilities allows us to assist our clients to analyze their novel drug entities.

BioPharmaceuticals GMP Testing

Pace Analytical Life Sciences offers testing services to support the biopharmaceutical manufacturing industry. Our team of experts and our extensive selection of testing equipment offers you the services and expertise to support the development of new therapies and to ensure the quality of your marketed therapeutic proteins, synthetic peptides, enzymes, conjugates, and specialty molecules.

Microbiology

Pace Analytical Life Sciences is a full-service contract analytical testing laboratory providing microbiology testing services to the pharmaceutical and medical device industries. PLS has expertise in testing many dosage forms, including: transdermal delivery systems, aerosols, creams/ointments, tablets and capsules, medical devices and device/drug combination products.

Raw Materials Testing

Pace Analytical Life Sciences (PLS) provides raw material testing services to the pharmaceutical, biopharmaceutical and medical device industries. We offer excipient testing to support USP/NF (United States Pharmacopoeia/National Formulary), EP (European Pharmacopoeia), BP (British Pharmacopoeia), JP (Japanese Pharmacopoeia), ChP (Chinese Pharmacopoeia), FCC (Food Chemical Codex) and ACS (American Chemical Society, Reagent Standards) monograph testing requirements. We also can test following client-supplied or vendor supplied methodology. Our raw material testing supports formulation development within research and development, excipients and active pharmaceutical ingredients used in finished product manufacturing and supports the qualification of our client’s raw material vendors.

Elemental Impurities

Pace Analytical Life Sciences offers full-service laboratory capabilities for assessing levels of elemental impurities in raw materials, in-process formulations, finished products, and medical devices. Elemental metals may be formulated into products for functional, therapeutic, and nutritional benefits, or elements may be natural, process, or contaminant impurities.

Stability Testing & Storage

Pace Analytical Life Sciences (PLS) operates a state of the art contract analytical laboratory that provides stability testing and stability storage support to the pharmaceutical, biopharmaceutical and medical device industries. All of our laboratory sites meet the requirements for stability studies, shelf life testing and shelf life determination. We conduct ICH stability studies following client supplied methods, compendial methods or methods that have been developed and validated by our own analysts. Stability testing for virtually all types of drug formulations including, but not limited to, sterile injectable products, tablets, capsules, non-sterile liquids, transdermal products, aerosols, and medical device combination products are performed at all our Life Sciences locations. We support long and short-term (accelerated) stability programs as well as photostability programs for Research & Development and commercial products.

Extractable/Leachables

Pace Analytical Life Sciences (PLS) has developed a comprehensive approach toward extractable and leachable testing. PLS designs studies to identify extractables, compounds that can be extracted from a component under exaggerated conditions, and leachables, compounds that could migrate into a drug product or patient during direct contact under normal or simulate-use conditions.

WEBINAR: Extractables and Leachables of Biopharmaceutical Container Closure Systems

Live Webcast Thursday, September 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

As biopharmaceutical drug product development continues to grow, so do new regulations on packaging and container closure components associated with delivery of the drug product to the patient. This webcast will present a brief introduction to extractables and leachables (E&L), followed by a  discussion of relevant United States Pharmacopeia and ISO guidelines and practical considerations when planning an extractables and leachables project.

Topics covered in this webinar:

  • Review results and analysis of an E&L case study of biopharmaceutical single-use bag systems
  • Gain an overview of the process, procedures, and approaches for biopharma E&L studies
  • Understand analytical capabilities and expertise needed to conduct effective studies

Speakers:

Daniel Abate, Ph.D.
Principal Chemist
Pace Labs

Hannah Tims, PhD
Principal Chemist
Pace Labs

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