Raw Materials - Pace Life Sciences

Confidence at the foundation

Raw materials data is essential to protecting downstream manufacturing and keeping programs on track. Our raw materials quality control testing helps safeguard your drug product from delays, deviations, and recalls by establishing clear, defensible data from the start.

We maintain proven cGMP systems to provide the scale and flexibility necessary for both routine release and complex qualification needs. Our experienced teams verify the identity, purity, and quality of APIs and excipients, support vendor qualification, and perform testing using compendial, client-supplied, or vendor-supplied methods. This customization allows us to deliver results you can trust at every stage of your supply chain.

Our raw material testing services include:

QC raw materials testing: Identity, purity, and quality testing for APIs and excipients to support confident release and downstream manufacturing decisions.
Vendor qualification support: Data-driven testing programs to help qualify and maintain approved raw material suppliers.
Compendial and method-based testing: Execution against compendial, client-supplied, vendor-supplied, or custom methodologies with robust verification programs.
Expedited and just-in-time testing: Fast, accurate turnaround options designed to keep manufacturing schedules moving.
Network-backed continuity: Replicated capabilities and capacity across multiple GMP laboratories to reduce business risk and support continuity.
Late-phase and post-approval support: Ongoing testing and change support as products progress through lifecycle milestones.

Testing raw materials across phases and modalities

Our raw materials testing considers the unique aspects of each product, starting material, production process, and requirement relevant to your progress.

Drug substance
Drug product

Drug substance

While the drug substance of small molecules benefits from focus on starting materials, reagents, and catalysts, other modalities are more complex. Biologics require insight into upstream materials, like media and cell substrates. Nucleic acids more so focus on plasmids, enzymes, and nucleotide substrates.

Drug product

Raw materials testing for drug products should reflect the production processes when evaluating risks. For small molecules, this means ensuring excipient compatibility and stability. Biologic drug products often check for formulation buffers, surfactants, and container-closure interactions. Evaluating nucleic acids drug products can entail testing lipid nanoparticle components and stability.

USP <467> Residual Solvents Compendial Verifications

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Secure data accessibility

PacePort is our secure client data access portal; a web-based data delivery system that allows you to access to methods, specifications, reports, and other information at any time, from any location. The materials available via PacePort are of sufficient quality to be used during audits.

Portal access

Standards-driven testing, built for compliance

Our raw materials testing is grounded in globally recognized pharmacopeial standards and supported by flexible methodologies to meet both established and novel material requirements.

Compendial Methods

Achieve consistent quality, regulatory compliance, and confident release decisions by partnering with our seasoned team to complete essential compendial raw material testing. We have a longstanding track record of delivery timely results spanning various pharmacopeial and industry standards. Our FDA- and DEA-registered laboratories operate under cGMP conditions and are ISO/IEC 17025 accredited, ensuring the highest level of quality control for APIs and excipients.

Our compendial testing experience includes:

United States Pharmacopoeia / National Formulary (USP/NF)
European Pharmacopoeia (EP)
British Pharmacopoeia (BP)
Japanese Pharmacopoeia (JP)
Japanese Pharmaceutical Excipients (JPE)
Chinese Pharmacopoeia (ChP)
Food Chemical Codex (FCC)
American Chemical Society, Reagent Standards (ACS)

Custom Methods

While compendial methods form the foundation of many raw materials programs, we recognize they are not always available or appropriate, particularly for novel or specialized materials. Our teams are equipped to support both established and custom analytical approaches adapted to your program specific needs.

If you have existing methods, we can transfer them seamlessly into our laboratories. When suitable methodology does not exist, we develop and execute phase-appropriate validations of custom methods, including Client Laboratory Methods (CLMs). CLMs remain sponsor-owned and, once established, can be used for routine testing or transferred across Pace® Life Sciences numerous GMP testing laboratories to support scale, continuity, and lifecycle progression.

On demand webinar: Challenges with verification of compendial chromatographic methods

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Multifaceted molecular expertise

Small Molecules
Biologics
Nucleic acids
Novel products

Small Molecules

Despite the rise of biologics, gene therapies and cell-based medicines, small molecules remain one of the most important therapeutic modalities in drug development. Our teams have decades of experience in the development of these cost-effective, often orally delivered, and stable modalities for any number of indications including oncology, cardiovascular, neurology, immunology, and rare diseases.

Biologics

Biologics, which include any number of large molecules, such as recombinant proteins, monoclonal antibodies, ADCs, and gene/cell therapies, have become one of the most significant classes of drugs in modern medicine. Our scientists are experienced in the development of this important and ever-evolving area to exploit their high target specificity, ability to treat previously untreatable diseases, and often long duration of action.

Nucleic acids

Nucleic acids, which are the building blocks of DNA and RNA, have become one of the most transformative therapeutic modalities in modern pharma. Unlike small molecules or biologics that interact with proteins, nucleic acid–based drugs can modulate gene expression directly, enabling entirely new ways to treat or even cure disease.

Our diverse experience spans chemically synthesized oligonucleotides (e.g., ASO, siRNA, aptamer, sgRNA, PMO/PPMO, etc.) as well as larger nucleic acid polymers produced by biological processes, such as in vitro transcription (e.g., mRNA, tRNA, circular RNA, etc.) or bacterial expression (e.g., plasmid DNA).

Novel products

Push the boundaries of what’s possible in drug development with our forward-looking partnership to help navigate uncertainty. We apply diverse molecular experience with proven processes and advance technologies to advance your product toward clinical phases.

Our team specialized numerous carriers to safeguard your API from environmental influences while optimizing pathways to the targeted cell and tissue types. Some of these include virus like particles (VLPs), viral vectors, adeno-associated virus (AAV), lipid nanoparticles (LNPs), and antibody-drug conjugates (ADCs).

Analytical testing to help you move forward and stay ahead

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Whether you’re shaping early plans or preparing to scale, our teams are here to help you move forward with clarity and confidence. Start the conversation and we’ll get back to you quickly.

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