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Pharmaceuticals and Biotech

Industries / Pharma/Biopharmaceutical

Pace® Services for Pharmaceuticals and Biotech

Pace® supports numerous aspects of the pharmaceutical and biotech lifecycle, from research and development to commercialization and facility management. No matter the scale of your operations, our technical expertise and exemplary customer service fill the gaps and empower progress with integrated offerings.

Contract Research and Development Services for Drug Developers

Analytical Characterization

Pace® offers specialized services for the analytical characterization of biologics, catering to the pharmaceutical industry's needs amidst the rapidly advancing field of biotherapeutics. Our analytical characterization services include purity and identity assessments, post translational modifications, aggregation and structural assessments, and other parenteral quality attributes. Using the most advanced equipment, our team of experts produces the data you need to ensure the quality and functionality of your target molecule’s structure.

Biologics Characterization

Nucleic Acids Characterization

Novel Compounds Characterization

Preformulation

Pace® preformulation services generate insights to analyze critical molecular properties and behaviors. By applying advanced analytical techniques, we provide essential data that can guide formulation strategy and help mitigate potential issues in later development stages. Collaborating with Pace® helps you accelerate the development pipeline with solid state, polymorph, and salt screening, physicochemical characterization, and compatibility studies.

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Preclinical Research & Development

Pace® preclinical research and development services are designed to help drug developers navigate the complex path from concept to clinic. We use state-of-the-art technologies and methodologies to evaluate various dosage forms and excipients suited to the species, route of administration, and project objectives. We also prepare, test, and ship preclinical test articles with clear preparation instructions for smooth handoffs.

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Bioanalytical Services

Pace® bioanalytical services support lead selection and optimization to accelerate new drug discoveries. With robust assays tailored to your needs, our sample analysis results help you make confident, informed decisions for your regulatory submissions throughout the product life cycle. We also offer bioanalytical method development as well as GLP and non-GLP bioanalysis services to support your needs during the preclinical phase of your product.

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Analytical Development

Pace® analytical development services help accelerate your drug development process. We use proven techniques and the most advanced equipment to provide data you can rely on to validate product safety and efficacy. With experience spanning molecule types, dosage forms, and routes of administration, our experts can also tailor existing methods to meet specific endpoints.

Analytical Services for Small Molecules

Analytical Services for Biologics

Analytical Services for Nucleic Acids

Formulation Development

Oral, parenteral, nasal, ocular, intravitreal, or topical – Pace® formulation development services help you accelerate your formulation to clinical phases. Our expertise spans sterile and non-sterile products, a wide range of dosage forms, and various routes of administration. We have helped overcome many novel challenges across molecule types. Learn more about specific techniques and methods used for different drug types by clicking the links below.

Formulation Services for Small Molecules

Formulation Services for Biologics

Formulation Services for Nucleic Acids

Process Development

Pace® process development services can help ensure robust manufacturing processes support your drug development goals as you scale up. Whether your drug substance requires chemical modification or your drug product manufacturing requires process characterization, our experts can recognize your development phase, investigate solutions to remaining challenges, and prepare your program for the clinic. Our integrated laboratory services also enable us to test materials for release and evaluate long-term stability.

Specialty Processing Technologies

Process Development for Biologics

Process Development for Nucleic Acids

Custom Research and Development

If you are expanding the frontiers in pharmaceutical and therapeutic drug development, our team of experts is here to support your research and development targets. Visit our custom research page to learn more about our offerings for niche molecule types.

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Contract Manufacturing Services for Drug Manufacturers

Specialty Pharmaceutical Manufacturing Technologies

Some drugs require special types of processing to ensure potency and quality. We offer several specialty technologies, including nanomilling, hot melt extrusion, spray drying, and liquid-filled capsules, to help achieve your desired results.

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Clinical Supplies Manufacturing

Our extensive portfolio of GMP clinical supplies manufacturing capabilities covers a wide range of dosage forms. With decades of experience, our clinical supplies manufacturing team can also help developers overcome unique and complex manufacturing challenges on the path to market.

Small Molecule Clinical Supplies Manufacturing

Biological Clinical Supply Manufacturing

Nucleic Acid Clinical Supply Manufacturing

Clinical Packaging

In addition to helping you choose the right packaging and kitting, our clinical packaging services can prepare your products for distribution. We can accommodate a variety of configurations, custom labels, and flexible batch sizes to satisfy your needs.

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Contract Testing for Drug Manufacturers

Raw Materials Testing

 Pace® raw materials quality control testing helps you demonstrate the identity, purity, and quality of excipients and active pharmaceutical ingredients (API). Our team offers vendor qualifications and expedited turnaround time services for swift, reliable results. Whether you plan to leverage compendial methods or methods supplied by your team or vendors, we support a variety of industry standards and compendia.

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Lot Release Testing

Our team excels in a diverse array of identification, assay, impurity, potency, in vitro, and physical property testing for all your drug product batch release needs. Your test results and raw data are also available 24/7 via our PacePort® data portal, keeping you informed about the progress of your testing to meet your timelines.

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Physical-Functional Testing

Physical testing verifies consistent quality and adherence to regulatory requirements, which is complemented by functional testing to ensure a safe and effective product for patient use. Our state-of-the-art laboratories are equipped with advanced instrumentation to conduct a comprehensive array of tests, such as tensile strength, compression, hardness, dissolution, disintegration, and friability of products. These tests help confirm the reliability, durability, and performance of your products, ensuring their function is up to the standards required for patient safety and regulatory compliance.

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Stability & Storage Testing

Ensure regulatory compliance with our stability studies, shelf-life testing, and shelf-life determination services. Our storage testing can assess how your product withstands a variety of conditions, such as freeze/thawing cycles, photostability, and variable custom storage conditions. These stability storage chambers are mapped and continuously monitored using a validated system and supported by external back-up power generators.

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Packaging Testing

Determining a satisfactory packaging configuration is an essential component of bringing a drug to market. Drug packaging must protect the product and be able to withstand the impact of processes at every point in your supply chain. Pace® can help you choose the most appropriate packaging by evaluating the performance, strength, integrity, and materials of the option(s) you have selected. We also test how well your labeling will withstand the rigors of moving your product from point of manufacture to consumer.

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Distribution Testing

New discoveries and innovations in life sciences are leading to exciting advancements in drug delivery systems. If your research or product development includes drug/device combination products, we can help.

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Drug/Device Combination Products

Determining a satisfactory packaging configuration is an essential component of bringing a drug to market. Drug packaging must protect the product and be able to withstand the impact of processes at every point in your supply chain. Pace® can help you choose the most appropriate packaging by evaluating the performance, strength, integrity, and materials of the option(s) you have selected. We also test how well your labeling will withstand the rigors of moving your product from point of manufacture to consumer.

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Pace Life Sciences scientist working in laboratory.
Reference Standards

Pace® helps establish a reliable baseline for your analytical testing with credible reference standards verified by our team. We characterize, store, and distribute reference standards to support development and manufacturing processes so you can have confidence in your product’s purity, identity, and stability. By maintaining secure and environmentally controlled storage facilities, our team ensures the integrity of your reference standards throughout their lifespan.

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Extractables/Leachables

Demonstrate product safety and efficacy through our comprehensive extractables and leachables (E&L) testing. Our approach identifies and quantifies potential contaminants that could migrate from your packaging materials or implantable devices into your drug products. We perform chemical characterization of extractables by subjecting your product to worst-case conditions for constituent identification. Targeted leachables studies are then developed to specifically quantitate compounds of concern that were initially detected.

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Elemental Impurities

Verify the levels of elemental impurities in your raw materials, in-process formulations, and finished pharmaceutical and medical device products. Whether you need to demonstrate a level of control for regulatory compliance or monitor for a label-claim, our team has a wide range of experience using several instrumental techniques.

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Microbiology

Ensure the safety and effectiveness of your pharmaceutical, biopharmaceutical, or medical device product with our reliable microbiological lab testing services. With a strong focus on GMP compliance and industry standards, we prioritize accuracy in every microbiology test we perform. Our experienced professionals offer tailored solutions aligned with USP/NF, EP, JP, and client-supplied methodologies, ensuring that your unique testing needs are met.

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Analytical Testing

Assure your product’s quality and purity with comprehensive analytical method development and testing. We identify and characterize impurities for safety and purity. Your active ingredient content is precisely measured with validated analytical methods to ensure consistent dosing and therapeutic effect. In addition to quantitative tests, we offer qualitative limit tests to determine the presence or absence of specific impurities. Our team also applies activity assays and cleaning verifications as part of our analytical development and testing.

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Facilities Management for Pharmaceutical Manufacturing & Biotech

Pace® facilities management solutions can help ensure your operational environment adheres to strict regulatory compliance standards and Good Manufacturing Practices (GMP). Explore our facilities services below. 

Pace Scientist working in laboratory.

Scientific Staffing Services

Finding, hiring, and retaining laboratory talent can be challenging. Pace® scientific staffing services can help you bridge the talent and resource gap with people who understand and support your science.   

Water Management Services for Pharmaceutical Manufacturers

Water for Pharmaceutical Use

The U.S. Food and Drug Administration (FDA) provides detailed guidelines on water for pharmaceutical use, emphasizing its critical role in the manufacturing process. These guidelines include specifications for different types of water quality like purified water, highly purified water, water for injection (WFI), and sterile water for injection. The FDA aligns its standards with the Environmental Protection Agency's Primary Drinking Water Regulations (NPDWR) to ensure that water utilized at the outset of pharmaceutical manufacturing meets acceptable levels of purity and safety.

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USP General Chapter <1231>

Chapter <1231> of the United States Pharmacopeia (USP) outlines the different grades of water quality used in the production of pharmaceuticals, e.g., purified water, water for injection, etc. In addition, USP <1231> delineates the required production methods, storage, and distribution systems to ensure that water meets the stringent quality attributes appropriate for its use. Continuous monitoring and validation processes are emphasized to maintain water quality in compliance with pharmacopeial standards, thereby safeguarding the efficacy and safety of pharmaceutical products. Contact us to learn more about how Pace® can help your organization adhere to all USP <1231> for water quality and safety.

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ST108 Compliance Testing for Drug/Device Combination Manufacturing

ST108 is a critical standard within the medical device manufacturing industry, focusing on ensuring that water used in the processing of medical devices meets stringent quality requirements. This standard, defined by the Association for the Advancement of Medical Instrumentation (AAMI), establishes comprehensive guidelines for testing and maintaining water quality at safe and effective levels for cleaning, disinfecting, and sterilizing medical devices. Pace® provides water quality testing services for each of these areas designed to meet the requirements of ST108 compliance, including microbial content, endotoxin levels, mineral content, and more. 

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Water Systems Testing for Waterborne Pathogens

In pharmaceutical facilities where water systems are used in manufacturing processes, testing for Legionella and other waterborne pathogens may be warranted. Factors such as sediment, scale, corrosion, and biofilm within water systems can provide a habitat and nutrients for these pathogens to grow. In addition, construction or remodeling projects can lead to the proliferation of these harmful pathogens.

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Water Systems Validation

USP-purified water and Water for Injection systems are fundamental to your operations, and their compliance should be a top priority. Our team supports water systems validation to help ensure a reliable, consistent supply.

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Regulatory Resource Library

FDA Regulatory Consulting

With a deep understanding of global regulatory requirements, Pace® experts can assist you in navigating the intricacies of bringing a drug product or drug-device combination to market. Considering the many compliance requirements that apply throughout the life of that product, explore some of our solutions below or contact us to start a conversation. 

USP <797>

Pace® sample culture and analysis services help compounding pharmacies, hospitals, and other healthcare providers adhere to USP <797> guidelines to ensure the safety and efficacy of compounded sterile preparations (CSPs). Our analysis services include:  

Gloved Fingertip Sampling
Media Fill Testing
Aseptic Competency Testing
Viable Air Sampling
Viable Surface Sampling
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Navigating the Revised USP <797> Standard for Environmental Monitoring
Environmental Impact Assessments

Environmental Impact Assessments

Like other manufacturers, pharmaceutical companies need to keep a close eye on their environmental impact. Pace® has decades of experience helping companies comply with local and federal regulations (RCRA, CERCLA, TSCA, NPDES etc.) and build public trust by demonstrating good environmental stewardship. Explore our environmental testing services to learn more.

Pace® Building Sciences

“Sick building syndrome” refers to a situation where the occupants of a building experience acute health issues linked directly to the time spent in the building. Despite the cleanliness of most pharmaceutical manufacturing facilities, challenges can arise from issues like vapor intrusion, radon, lead, and other environmental contaminants. The Pace® Building Sciences team can help you promote a safe, healthy work environment for your employees. 

Additional Resources