We're here to help you bring safe and effective biologics to market with comprehensive testing from discovery through IND, BLA, and beyond
As a true partner, we're invested in helping you achieve your goals. Our experienced team of biochemists, cell biologists, and polymer and organic chemists are here to help you solve the most complex challenges along the pathway to regulatory approval. Bring safer, more effective biologics to market faster with Element by your side. Ready to get started? Click the orange button below to email us. A member of our team will be in touch with you promptly.
Accelerate efficiencies and break down roadblocks
We'll help you meet the highest standards for safety and reliability, without slowing down time to commercialization. Element's experts will be by your side throughout the product lifecycle. From accelerating pre-clinical drug discovery with integrated discovery biology services to developing robust cellular potency or in vitro efficacy methods, we're committed to delivering the high quality data you need for regulatory submissions and release.
You'll meet timelines without sacrificing quality. Our flexible, tailored approach incorporates parallel paths to get you the answers you need faster, all while meeting the intent of regulatory requirements.
Satisfy regulators and meet the needs of patients
We're here to help you implement a strong CMC strategy for your biologic that meets both regulatory expectations and intent. We'll help you monitor critical quality attributes (CQAs) throughout development, ensuring both safety and efficacy to avoid costly delays. By leveraging our qualified platform methods for impurities, you'll get data back faster, saving you time and avoiding delays in IND submission.
Element's experienced scientists can also develop, optimize, and transfer fit-for-purpose analytical methods, in addition to carrying out phase-appropriate method validation and raw material analyses for both mammalian and microbial expression systems. Plus, we'll help you overcome challenges with custom method development.
You can rely on Element's significant expertise in all stages of biologics R&D and in-house biochemistry, molecular biology, cellular biology, and QC experience. Ready to start the conversation? Just fill out a short form and a member of our team will be in touch with you.
Get to know Element
Scroll down for the complete list of qualified CMC platform methods we offer. Keep scrolling for a handful of the many services we offer to help you achieve regulatory approval quickly and efficiently.
Check out the complete list of available biologics CMC platform methods
You'll save time and money with Element's established, qualified platform methods for many common process-related impurities.
Click the orange "view methods" button for the list of qualified CMC platform methods we offer for biologics.
View methodsYour global partner from discovery to market
Still researching? Here are a handful of our many services to help achieve regulatory approval quickly and efficiently.
ICH Stability Testing of Pharmaceuticals and Biologics
We'll help you develop comprehensive stability programs that meet ICH Q1A-F requirements for IND, ANDA, and NDA approvals of small and large molecule drugs.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
Pharmaceutical and Biopharmaceutical Unknown Identification and Impurity Testing
Our experts work closely with customers at every stage of the product lifecycle to identify unwanted compounds and ensure products are pure, safe, and quality.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Excipient Raw Materials and Container Testing
Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.
Compendial Testing
ICH, USP, EP, BP and JP monograph tests of raw material, drug substance/product, starting material, cell banks, vectors, bulk harvest and control cells.
Microbiological Development and Quality Control Testing
Our microbiology lab provides microbiology testing services and quality control for a variety of drug products, ensuring they are safe, quality, and compliant with relevant regulatory standards.
Environmental Monitoring
Our Environmental Monitoring programs allow pharmaceutical manufacturers and compounders to measure and monitor cleanliness and contamination levels within their facilities.