Custom Biologics

Fun fact: The FDA has detailed guidelines for industry on clinical testing of biotherapeutics. 👇 Shown here are two from the FDA: Bioanalytical Method Validation: Guidance for Industry: https://lnkd.in/g2YGzwnv  Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products: https://lnkd.in/giY6H-Wq At Custom Biologics, we will help you navigate the requirements and provide the assays you need to develop a safe and stable drug product. Talk to our science team to get started: https://lnkd.in/grB6j-2v

Our team is soon heading to New Orleans for #WRIB! If you’ll be there, be sure to visit us at booth #40 to discuss your latest large molecule bioassay needs. ✅ Cell-based potency assays ✅ ELISA ✅ Immunogenicity (ADA/Nab) assays ✅ AAV Characterization/Transgene Expression ✅ Biomarker quantification ✅ PK/TK Studies #Mabs #Biosimilars #ADCs #OncolyticViruses #GeneticMedicines Want to meet? Complete this quick form (https://lnkd.in/grB6j-2v) or message our team members Dan Mamelak, PhD, CEO Kalhari SILVA, PhD, Head of Scientific Research & Innovation Yushmee Goorriah-Bazerque, Quality Assurance Specialist

#WRIB (Workshops on Recent Issues in Bioanalysis) is fast approaching! If you have plans to visit New Orleans, April 7-11, stop by the Custom Biologics stand to say hello and view our poster. And of course, schedule time to meet with our Head of Scientific Research & Innovation, Kalhari SILVA, PhD, who will be in attendance. Want to connect? DM our page, or Kalhari directly, to book a meeting.

In the first part of this series, we discussed the four main types of immunogenicity assays, specifically delving into anti-drug antibody (ADA) assays for therapeutic biologics and other drugs. In part II of our four-part series, we continue the conversation by exploring another key type of immunogenicity assay: Neutralizing Antibody (NAb) assays. Read the post: https://lnkd.in/gB_zKqAN

There’s no substitute for a robust pharmaceutical quality system. 📋 About our Independent Quality Assurance Unit: ✅Quality Systems adhere to FDA guidelines 21 CFR Parts 11, 58 and 211, OOS/Deviations/CAPA ✅Pharmaceutical Quality/CMC Testing ✅Comprehensive Reporting for Regulatory Submissions ✅QA Manager: PhD trained with over 25 years QA experience with big pharma Explore our #QA capabilities: https://buff.ly/xBn4vHv

Curious about our #bioanalytical capabilities? 🧪🧬 For 20+ years, we've been specializing in regulatory-compliant cell-based and immunoassays to measure the bioactivities and clinical properties of biotherapeutic drugs. Explore our services, from cell-based bioassays and #immunogenicity to stability/lot release testing, protein characterization and much more. Learn more: https://buff.ly/JPgNuKV

Confirming purity of cell and gene therapy products is just one of the FDA’s required Critical Quality Attributes 💉🧬 Our scientists can help you identify any impurities (e.g., residual host cell proteins and DNA, viral DNA, plasmids) using analyses including: ✅#ELISA ✅qPCR ✅Digital droplet #PCR Our methods and limits comply with the regulatory guidelines of the FDA, the United States Pharmacopeia and the World Health Organization Learn more about our assays at custombiologics.com

Will we see you at #WRIB (Workshops on Recent Issues in Bioanalysis) in New Orleans, April 7-11? We’re delighted to have an enhanced presence this year! Stop by the Custom Biologics stand to view our poster.🧪 And of course, schedule time to meet with our Head of Scientific Research & Innovation, Kalhari SILVA, PhD, who will be in attendance. Want to connect? DM our page to book a meeting.

In recognition of #RareDiseaseDay, we support those living with rare diseases and acknowledge the companies–here in Canada and globally–working to develop therapies to treat these diseases. Developing rare disease drugs presents unique challenges, from navigating ultra-sensitive assays, small sample sizes, and the need for highly specialized methodologies to ensure accurate pharmacokinetic, immunogenicity, and biomarker assessments. Bioanalysis is just one step of the process, but we are pleased to support our customers in getting rare disease therapies to patients around the world. 🩷

Bioanalytical testing is crucial for drug development, and it has become even more important as the complexity of drugs like biologics and gene therapies evolves. Learn the exact steps in which bioanalytical testing supports drug development - from formulation to market approval: https://buff.ly/4k3z4N8