ABOUT PACE LIFE SCIENCES
Pace® Life Sciences offers a comprehensive suite of contract services—including CMC development, clinical trial material (CTM) manufacturing, regulatory consulting, and facility support—for the pharmaceutical, biopharmaceutical, and gene therapy industries. With a nationwide network of CDMO sites, GMP analytical labs, and support centers, we are positioned to move your program efficiently from early development through commercialization.
Our expert teams and investment in state-of-the-art facilities reflect our commitment to providing reliable, high-quality services and a seamless client experience at every stage.
Pharmaceutical Development Services
Our development labs offer IND-enabling support to advance therapies through preclinical stages, including the characterization of:
- Small molecules
- Biologics (proteins, peptides, antibodies, ADCs)
- Gene therapies (e.g., oligonucleotides)
Early-Phase Development Services:
- Lyophilization and spray-drying process development
- Analytical method development and validation
- Test article preparation
- CTM manufacturing and packaging
Technology transfer to our GMP facilities ensures a smooth progression from preclinical through commercial phases, in full compliance with regulatory standards.
Integrated Services to Support Your Entire Lifecycle
Pharmaceutical Development
- Preformulation & formulation development
- Bioavailability enhancement
- Clinical supplies manufacturing:
- Sterile products
- Tablets, capsules
- Solutions, suspensions
- Semi-solids, creams, ointments
- Clinical packaging
- Analytical development and method validation
- Solid-state API characterization
- Nitrosamine risk assessment
- Extractables/leachables testing
- Stability storage & testing
GMP Laboratory & Commercial Support
- Raw materials clearance
- In-process and finished product testing
- ICH stability programs
- Reference standard management
- Elemental impurities & physical testing
- Microbiological testing
Facility Services
- Commissioning & qualification
- Utility & equipment validation
- Lab relocations
Consulting Services
- Regulatory strategy and agency interaction
- Quality and compliance consulting
Flexible Service Models and Commitment to Quality
Capacity:
We support clients of all sizes with adaptable engagement models, including fee-for-service, dedicated resources, FTE programs (on-site or at client locations), ensuring cost-effective solutions.
Quality:
Our facilities have a strong track record of successful inspections by regulatory agencies and clients, delivering the high-quality data needed to move your program forward.
Reliability:
Our integrated approach ensures your program stays on schedule—on time and on budget.
INDUSTRY INSIGHTS
-
![GettyImages-1158419849 lab]( "Formulation Development For Therapeutic Oligonucleotides")
Formulation Development For Therapeutic OligonucleotidesDiscover how expert formulation and analytical support enable the development of stable, injectable oligonucleotide therapies across diverse delivery routes and molecule types.
-
![GettyImages-1088537588 disease]( "EMA Support For Rare Disease Therapies")
EMA Support For Rare Disease TherapiesReview how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
-
![GettyImages-2149039456 lab, research, microscope]( "The Role Of A Consulting Firm In The IND Process")
The Role Of A Consulting Firm In The IND ProcessNavigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.
-
![GettyImages-952307842-biobanking-deep freeze-biological sample]( "Lyophilization To Enable Drug Products Containing Labile Molecules")
Lyophilization To Enable Drug Products Containing Labile MoleculesDevelop lyophilized formulations to overcome stability challenges and significantly extend the shelf life of sensitive therapeutic products.
-
![injecting vaccine vaccination-GettyImages-665515600]( "Injection Site Reaction Screening Methodology")
Injection Site Reaction Screening MethodologyOptimize drug formulations for solubility at physiological pH to reduce injection site reactions, enable high-concentration dosing, and enhance patient comfort and compliance.
-
![GettyImages-1316775813 fill finish pharmaceutical bottles]( "Fill-Finish Contract Manufacturing: Trends, Challenges, And The Future")
Fill-Finish Contract Manufacturing: Trends, Challenges, And The FutureSee why it's important to partner with a CDMO that’s investing in advanced sterile fill-finish capabilities to meet the demands of complex biologics, gene therapies, and mRNA-based products.
-
![GettyImages-1691974990 extracellular vesicle EV]( "Engineering The Future Of Lipsomal Drug Delivery")
Engineering The Future Of Lipsomal Drug DeliveryExplore our full collection of case studies to discover how liposome technology is transforming drug delivery across a wide range of therapies.
-
![GettyImages-1938555104-laboratory-equipment-scientist-windows]( "Advancing Drug Development With Optimized LC-MS/MS Bioanalysis")
Advancing Drug Development With Optimized LC-MS/MS BioanalysisExplore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.
-
![GettyImages-1327073629-scientist-working-on-equipment]( "Advanced Methodology Of PLGA-Based Parenteral Formulations")
Advanced Methodology Of PLGA-Based Parenteral FormulationsTo enable the development of optimized PLGA-based sustained release formulations, this paper offers essential insights into the polymer’s properties, fabrication techniques, and drug release mechanisms.
CONTACT INFORMATION
Pace® Life Sciences
1131 Helmo Ave N
Oakdale, MN 55128
Phone: 612-656-1175
Contact: Chelsea Simpson, Associate Director, Marketing
SOLUTIONS
-
![GettyImages-2174865773 vial testing, lab]( "Advancing Nitrosamine Testing For Evolving Regulations")
Advancing Nitrosamine Testing For Evolving RegulationsExplore how specialized analytical expertise and advanced instrumentation enable precise nitrosamine testing to help drug developers meet strict and evolving regulatory requirements.
-
![GettyImages-2158124620-scientist-laboratory-containers-testing-analysis]( "Extractables And Leachables")
Extractables And LeachablesEnsure the safety, quality, and regulatory compliance of your pharmaceutical or medical products with robust extractables and leachables testing tailored to identify potential risks under both exaggerated and real-use conditions.
-
![GettyImages-1087219366-filling-vials-mechanical]( "Aseptic Fill-Finish")
Aseptic Fill-FinishWhether you are navigating technical hurdles, scaling production, or preparing for market launch, our integrated approach ensures a seamless path from bench to bedside.
-
![GettyImages-1371925389-lab-scientist-collaboration-computer-clipboard]( "Bioanalytical Development And Testing For LNPs")
Bioanalytical Development And Testing For LNPsStreamline gene therapy development by partnering with a centralized, GLP-compliant bioanalytical lab for comprehensive biodistribution studies using techniques like LC-MS/MS, RT-qPCR, and ELISA.
-
![GettyImages-2151198847-lipid-nanoparticle-with-rna-strands]( "Oligonucleotide Lipid Nanoparticle Production And Characterization")
Oligonucleotide Lipid Nanoparticle Production And CharacterizationAdvancing safe and effective oligonucleotide delivery requires microfluidic mixing to produce lipid nanoparticles with precise size control, stability, and scalability.
-
![GettyImages-1751659695-laboratory-scientists-computer-analysis-evaluation]( "High Resolution Mass Spectrometric Analysis Of Complex Biotherapeutics")
High Resolution Mass Spectrometric Analysis Of Complex BiotherapeuticsUnderstand why continued research and collaboration between industry and regulatory bodies are essential to define guidelines that ensure safety and efficacy in this rapidly advancing field.
-
![Pace April OPCU Analytics]( "Pace Life Sciences Capacity Update April 2025: Analytical Services")
Pace Life Sciences Capacity Update April 2025: Analytical ServicesGain a strategic edge through customized solutions, reliable metrics, and a clear pathway to successful downstream testing, ensuring your therapeutics reach patients faster.
