SAFC® Expertise
Industry-leading expertise, just a click away
As a leading manufacturer of critical raw materials for therapeutic drug production, our technical and regulatory experts are committed to ensuring you a smooth and successful journey to market. Explore our portfolio and access a library of resources including case studies, webinars, videos, application notes, and technical briefs from our raw material experts.
Upstream process development and cGMP solutions tailored to your needs and fully backed by regulatory documentation and support.
CHOZN® CHO Expression System
A CHO platform for fast, easy, metabolic-free selection and scale-up of clones for manufacturing.
The CHOZN® platform includes CHO cell lines, paired media & feeds, and optimized protocols that result in predictable, stable high titers. This platform is fully supported with quality documentation, regulatory-friendly ZFN gene editing technology, and expert consultation services.
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- Video: Accelerate Your Upstream Process Development Timelines
- Video: Demonstrating Process Scalability
- Video: Streamlining Biopharmaceutical Cell Line Development
- Video: Cell Line Platform for Performance & Speed to Clinic
- Video: Make the Right Cell Line Choice for Your BioPharmaceutical Production
- Poster: CHOZN® Facilitates Cell Line Engineering and Characterization
CHO Cell Culture Media & Feeds
Chemically defined, ready-to-use CHO media designed for commercial fed-batch and perfusion processes – enabling high titers, robust scalability, superior protein quality, and accelerated time to market.
Rely on Cellvento® and EX-CELL® Advanced media products for:
- Consistent high cell growth and productivity
- Increased productivity with the right feed combination
- Proven success in batch, fed-batch and perfusion modes
- Comprehensive documentation and support
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ImMEDIAte ADVANTAGE® Lab Services
We support biopharmaceutical manufacturing and process development with expedited timing of small volume custom cell culture media recipes.
- We formulate cell culture media to your specification
- Our fast-track services accelerate media development and optimization timelines
- Our compounding methods and qualified raw materials ensure consistency and scalability of your formulation to full-scale GMP manufacturing
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Compacted Cell Culture Media
Designed to meet your need for ease-of-use, convenience and operator safety.
Our compacted raw materials and cell culture media, including Cellvento® 4CHO and Cellvento® 4Feed, are dust-free, ready-to-use materials with increased flowability for better handling, safety and processing. For cell culture media the advantage of compaction is in the significant reduction of dissolution time.
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EZ BioPAC® Dry Powder Bags
& Right Sized Weighing
Simplifies bulk powder transfers and additions, for all scales of operation, making operation faster, cleaner and safer.
- Enables a single worker to easily dispense specific quantities of media and buffer powders
- Minimizes product contamination risk and safeguards employees
- Increases process security and efficiency
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Modified Amino Acids
(phospho-tyrosine, sulfo-cystine)
Phospho-L-Tyrosine disodium salt and S-Sulfocysteine sodium salt can be used together, as a single addition, enabling highly concentrated, pH neutral feeds.
- Simplifies fed-batch processes and reduces pH spikes
- Enables the intensification of fed-batch cell culture processes
- Allows for room-temperature-stable formulations
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USP & DSP process chemicals in a range of quality grades, formats and packaging options, supported by our technical and regulatory experts and full documentation.
High Temperature Short Time (HTST) Treated Glucose
Prevent viral contamination of cell culture media feeds with High Temperature Short Time (HTST) Treated Glucose.
- Provides a point-of-origin solution to mitigate the risk of viral contamination
- Enables robust clearance of viruses
- Ready-to-use, fast, sterile filtered, scalable
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Benzonase® Endonuclease
Ensures efficient and compliant DNA and RNA removal in biopharmaceutical production across a wide range of operating conditions and applications, including:
- Purifying viral vectors with Benzonase® endonuclease Safety Plus Emprove® Expert
- Purifying viral vaccines, proteins and other biologics with Benzonase® endonuclease Emprove® bio
- Reducing biofouling and viscosity caused by nucleic acids
Benzonase® enzymatically degrades all forms of DNA and RNA without impacting proteolytic activity and includes our Emprove® documentation to support your regulatory filing— ensuring compliance, consistent quality and higher yields.
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Modified Amino Acids
(phospho-tyrosine, sulfo-cystine)
Phospho-L-Tyrosine disodium salt and S-Sulfocysteine sodium salt can be used together, as a single addition, enabling highly concentrated, pH neutral feeds.
- Simplifies fed-batch processes and reduces pH spikes
- Enables the intensification of fed-batch cell culture processes
- Allows for room-temperature-stable formulations
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Contract manufacturing services tailored to meet your project goals and exact performance, compliance and safety requirements at every step.
High Potency & Complex API CMO Services
Full portfolio of standard and custom raw material solutions for pharma and biologics; spanning the entire drug development process - from chemical and biological API synthesis to final formulation
- World-class, single point of contact project management
- Global cGMP facilities for clinical to commercial scale API manufacturing
- Analytical and process development services to support every stage
- Manufacturing capabilities from grams to tons
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Antibody-Drug Conjugation CMO Services
Discover the partner that puts your goals first, fast tracks your production and helps you accelerate your processes.
- Comprehensive CMO services for developing and commercializing Antibody-Drug Conjugates (ADCs)
- Proven industry leader with more than 30 years of experience in GMP bio-conjugation and the development of more than 65 constructs
- Our service portfolio covers all the critical steps of your ADC development and manufacturing — mAb production, HPAPIs, linkers and complex bioconjugation, including analytical and stability testing — all from a single source
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Chemiflex™ Critical Raw Materials Program
Mitigate risks for small molecule API synthesis with Chemiflex™ Critical Raw Materials Program.
Our Chemiflex™ Program enables you to customize critical properties of your API synthesis including material, quality, and quantity and:
- Meets regulatory requirements for transparency and traceability
- Ensures full regulatory support and documentation
- Includes both standard products & custom manufactured
- Dedicated regulatory support and EMPROVE® documentation packages
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Metafolin®/Arcofolin™ L-Methylfolate
Metafolin® and Arcofolin™ L-Methylfolate are the superior forms of folate supplementation as they are directly bioavailable, offering an excellent stability, high solubility and superior bioavailability compared to folic acid.
- Arcofolin™ provides a higher level of active folate, high purity and improved solubility in water.
- Developed by experts with 60 years of experience in the field of reduced folates and manufactured in a state-of-the-art facility with an outstanding cGMP track record.
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An extensive portfolio of excipients and drug delivery solutions to help accelerate your journey to market - supported by comprehensive regulatory dossiers.
Parteck® MXP Functional Excipient
Polyvinyl alcohol-based excipient for hot melt extrusion (HME) to solve formulation challenges with low solubility APIs.
- Fully compliant with US, EU and JPE pharmacopeias.
- Enhances API solubility
- Enables stable drug loads of 30% or more for a broad range of APIs
- Features a high thermostability (above 200 °C), thus broadening the applicable API range
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Granulated products for liquids Glycine Emprove® Expert
GMP-grade excipient with increased flowability for better handling, safety and processing — designed to meet your need for ease-of-use, convenience and operator safety
- Reduces caking behavior
- Provides a ready-to-use, dust-free material
- Fully compliant with Ph. Eur., BP, JPE and USP
- Supported with Emprove® documentation and EXCiPACT™ certificate
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Meglumine Excipient
Meglumine improves API solubility, bioavailability and stability in solid and liquid formulations.
Our Emprove® API and Emprove® Essential grades meet the highest quality standards and the needs of drug manufacturers, regulatory authorities, and patient.
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SynBiosys® Polymer Platform for sustained release of biologics
Reduce patient drug-dosing frequency with a new polymeric drug delivery technology that enables sustained release formulations for virtually any class of biological API.
- Reduces dosing frequency and maintains drugs at therapeutic levels longer, to improve patient compliance
- Suitable for large biological active pharmaceutical ingredients
- Scalable and easily adjustable to specific requirements
- Clinically proven safe
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Emprove® Program and Dossiers: Full supply transparency
The SAFC® portfolio of more than 400 raw and starting materials provides comprehensive documentation which addresses current regulatory requirements and anticipates future ones.
Emprove® dossiers simplify and speed your processes by:
- Accelerating approval preparation
- Increasing supply transparency and facilitating qualification processes
- Supporting risk assessment, management and mitigation plans
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