2025 And Beyond: Another Look At Upcoming NDSRI Regulations

The presence of nitrosamine drug substance-related impurities (NDSRIs) in medications has become an urgent issue for the pharmaceutical industry. Understand the acceptable intake (AI) limits.

The Fourth Principle Of Green Chemistry: Design Safer Chemicals

Chemists should strive to design molecules with the least environmental impact. They can utilize toxicologists and data to apply new metrics and issue guidelines to better assess the safety of chemicals.

Solve Complex Small Molecule Challenges

We specialize in the custom development and manufacturing of small molecule APIs, intermediates, and RSMs, offering scalable solutions from kilograms to multi-ton quantities.

SMB Technology: Optimizing API Purification

Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

ADC Payload-Linker Services

Explore how advanced high-potency capabilities and specialized expertise are driving the development and manufacturing of next-generation ADC payloads and linkers.

Simulated Bed Chromatography Advantages

Discover how Simulated Moving Bed (SMB) technology can revolutionize your purification processes by enhancing efficiency, reducing costs, and promoting sustainable practices.

SK pharmteco Capacity Update April 2025: Small Molecule

Join Nicholas Duda, Executive Director of Business Development, as he highlights our available capacity across North America, Europe, and Asia, and our unique capabilities.

SK pharmteco Capacity Update April 2025: Analytical Services

Get the quality, compliance, and accelerated development support you need for your small molecule and cell and gene therapy program with our advanced analytical testing services.

SK pharmteco's Texas Facility: A Pillar Of Innovation, Sustainability, And Pharmaceutical Excellence

Discover how SK pharmteco's innovative La Porte, Texas facility combines advanced technology, sustainability, and strategic efficiency to redefine excellence in pharmaceutical manufacturing.

Energetic And Specialty Chemistry Solutions

Partner with SK pharmteco to harness decades of expertise in safe, scalable, and reliable production of APIs using advanced energetic chemistry, delivering exceptional value from development to commercialization.

Lentiviral Vectors: The Key To Cell And Gene Therapy Success

Lentiviral vector manufacturing is complex and highly regulated, which is why a specialized CDMO is required to ensure safe, scalable, and compliant production from early development to commercialization.

Adapting rcLVV Assays For Commercial Manufacturing

Witness a validated dual-assay approach for sensitive, CGMP-compliant detection of replication-competent lentiviruses, enhancing safety and regulatory confidence in lentiviral vector manufacturing.

AAV Viral Titering Using Nanoplate-Based Digital PCR

Examine how nanoplate-based digital PCR streamlines AAV titering, providing faster results and greater accuracy, advancing gene therapy development from the lab to the clinic.

Adapting A rcAAV Assay For Commercial Manufacturing

Witness how to implement sensitive, cell-based qPCR assays to reliably detect rcAAVs and safeguard the integrity of your rAAV gene therapy manufacturing process.

SK pharmteco Capacity Update April 2025: Cell & Gene Therapy

Our integrated expertise — from plasmid science to viral vector and cell therapy manufacturing — can accelerate and de-risk the development of your advanced therapies.

SK pharmteco Capacity Update April 2025: Analytical Services

Get the quality, compliance, and accelerated development support you need for your small molecule and cell and gene therapy program with our advanced analytical testing services.

CGMP-Validated RCL Assay Used For Release Testing Of Manufactured Viruses, Gene Mediated Cell Therapy Products

Ensure the safety and efficacy of lentiviral-based therapies by addressing the risks of replication-competent lentiviruses (RCLs) through advanced monitoring and control strategies.

cGMP-Ready Clonal HEK293 Cell Line For AAV, Lenti-, And Adenoviral Vectors

See how this advanced SKPT-HEK293 4G9 was able to provide a robust, CGMP-ready solution for efficient viral vector production, supporting a range of AAV serotypes and CAR-T Lenti-viral vectors for scalable manufacturing.

SK pharmteco Capacity Update October 2024: Cell & Gene Therapy

Check out our enhanced capacity and expertise in supporting CGT projects, offering end-to-end solutions from viral vector and plasmid development to GMP manufacturing and regulatory support.

Cell & Gene Therapy Services

Fast-track your cell and gene therapies from cutting-edge process development to commercial success with advanced viral vector manufacturing solutions.

Control Strategies And Method Development For Nitrosamines In APIs And Drug Products

Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

Inspiring Waves Of Change

Our comprehensive capabilities include the production of Active Pharmaceutical Ingredients (APIs), advanced intermediates, Cell and Gene Therapy technologies, registered starting materials, and analytical services.

Shedding Light On Photo-Stability Forced Degradation

Ensure the stability and safety of your drug products by utilizing comprehensive forced degradation and photo-stability testing, guided by ICH and FDA standards, to identify degradation pathways and assess light exposure risks.

Stability And Storage Supported By Expert Scientists

Partner with SK pharmteco for reliable, ICH-compliant stability testing and storage solutions, supported by expert scientists and fully qualified chambers to ensure the safety and efficacy of your CGMP products.

Energy And Specialty Chemistry Solutions

Safely scale the production of APIs using highly energetic chemistry, backed by decades of expertise, controlled processes, and CGMP-compliant conditions from development to commercial manufacturing.

Stability And Storage Testing

Receive comprehensive stability testing solutions that ensure the safety, efficacy, and quality of your pharmaceutical products at every stage of development by partnering with us.

Nitrosamine Impurity And Control Testing

Get access to reliable testing services for the identification and quantification of impurities, ensuring product quality and maintaining patient confidence.

Control Strategies And Method Development For Nitrosamines In Peptide APIs And Drug Products

Pharmaceutical scientists and engineers must advance robust, sensitive, and efficient nitrosamine detection and control methods to ensure regulatory compliance and safeguard public health in peptide-based drugs.

Control Strategies And Method Development For Nitrosamines In APIs, Drug Products

Gain critical insights into nitrosamine control strategies, regulatory requirements, and advanced analytical methods to ensure compliance by August 2025.

Small Molecule Analytical Testing Services

With a comprehensive suite of capabilities, experienced professionals, and a proven track record, SK pharmteco ensures confidence and quality at every stage of the product lifecycle.