GMP manufacturing

bring ideas to life – for a better health worldwide Radiopharmaceuticals CDMO / CMOProducts See what makes the Difference Radelumin® is indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings: • Primary staging of patients with high-risk PCa prior to primary curative therapy• Suspected PCa recurrence in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.More Radiopharmaceutical Partner from Development to Global Supply ABX is a trusted partner in radiopharmaceutical innovation, combining 30 years of experience with expertise across development, manufacturing, regulatory support and global supply. Our integrated portfolio of radiopharmaceuticals, CDMO / CMO services and products helps bring.

analytical procedure developmentglobal distributionproject managementQC method developmentradiolabelingradiopharmaceutical developmentregulatory supportTech transfer

Acnos Pharma is a clinical trial supply company providing global clinical trial supply with a focus on patient care. It offers global and local sourcing, clinical secondary packaging and labeling, lab kits production, warehousing solutions, global logistics and quality management. The company supports pre-clinical through Phase I-III trials and acts as an extension of clients' teams.

clinical secondary packagingcomparator sourcingcustoms storageglobal logisticslabelinglab kit productionquality managementwarehousing

ABL is a biotech corporation headquartered in Rockville, MD, providing contract manufacturing and laboratory research services to advance vaccines and therapies from clinical development to the commercial market. It is a CDMO focused on viral vector manufacturing with GMP facilities in Rockville, MD and in Strasbourg and Lyon, France (ABL Europe). ABL has 30+ years of viral-vector development and GMP production experience.

analytical testingaseptic fill/finishassay development and qualificationcell and virus bankingimmunoassaysprocess developmentQC release testingscale upupstream and downstream process developmentviral vector manufacturing

Compass Biomedical is a research and development company focused on enabling cell and cancer therapies. It provides human platelet lysate products under the PLUS™ brand and offers contract research and manufacturing services supporting cell, blood, and tissue-based products from early proof-of-concept through process development, GMP manufacturing, and packaging.

biochemical analysiscustom assay developmentfill/finishFormulation Optimizationhematology panelslyophilizationpackagingpotency assaysprocess developmentscale upsterility testingtechnology transferviral safety testing

Artis BioSolutions is a synthetic DNA and advanced therapy platform company that combines proprietary enzymatic, cell-free synthetic DNA production (oDNA) with advanced therapy development and GMP manufacturing. It operates in the United States and European Union, with GMP and RUO manufacturing in Watertown, MA and Bilbao, Spain, supporting mRNA, gene editing, viral vectors, cell therapies, vaccines, and emerging biologics.

AAV viral vector manufacturinganalytical developmentCMC strategyenzymatic cell-free synthetic DNA manufacturingfill/finishlentiviral vector manufacturingLNP formulationmRNA manufacturingprocess developmentquality control

Bachem is a Contract Development and Manufacturing Organisation (CDMO) that develops and manufactures peptides and oligonucleotides as Active Pharmaceutical Ingredients (APIs), from early clinical development through to commercial GMP supply, for pharmaceutical and biotechnology companies worldwide. Founded in 1971, it operates four GMP-certified sites across Switzerland and the United States.

analytical capabilitiesclinical developmentcommercial manufacturingoligonucleotide manufacturingpeptide synthesisproject managementregulatory services

Beautifier LLC is a U.S.-based producer of sustainable beauty and skincare products, delivering beauty worldwide since 1993. It operates three major production facilities that are GMP, ISO 22716 and FDA-registered, with in-house laboratories and vertically integrated manufacturing resources. It collaborates with brands, retailers and private-label partners to refine existing formulations or develop new products.

FDA-registered productionformulation developmentin-house laboratoriesISO 22716 productionOEM/ODMprivate labelingvertically integrated manufacturing

BioInvent is a clinical-stage company that discovers and develops antibodies for cancer therapy. Based on expertise in immunology, cancer biology and antibody biology, it generates innovative immuno-oncology drug candidates using its proprietary F.I.R.S.T™ technology platform and n-CoDeR® antibody library. Its contract manufacturing unit, BioInvent Manufacturing, has produced drug substance for clinical trials since 1988.

antibody discovery and developmentclinical developmentF.I.R.S.T™ screening platformn-CoDeR® antibody librarysingle use technology

BiomeBank is a clinical stage biotechnology company with a mission to treat the microbiome and prevent disease by restoring gut microbial ecology. It develops next-generation microbiome therapeutics, including BIOMICTRA®, the world's first regulated donor-derived therapy, used to treat recurrent Clostridioides difficile infection, and is developing LYOMICTRA® capsule FMT.

co-culturing platform (CONSORTIOME®)donor screeningfaecal microbiota transplantation (FMT)microbiome research

Brain Armor Inc. makes science-backed brain health supplements, including plant-based Omega-3+ softgels and a Professional Strength Super Omega-3+ Liquid Concentrate. Its formulas combine algal-derived omega-3s (DHA and EPA), Vitamins D and E, and MCTs, and are made in the USA in a GMP facility. The company states its products are Informed Sport Certified, third-party tested, and free of sugar, gluten, artificial flavors, and sweeteners.

supplement formulationThird party testing

Founded in 2002, Cellex Incorporated is a biotech company that develops technologies, instruments and assays for testing human diseases and conditions, particularly for point-of-care (POC) professional healthcare settings. Based in Morrisville, NC, it maintains a GMP manufacturing site in Suzhou, China (ISO 13485 certified, FDA QSR) and an exclusive manufacturing partner in Zhengzhou. It has a lineage of more than 50 IVD diagnostic products.

Homogeneous Biochemiluminescence Assay (HBA)IVD product developmentLateral Flow Chromatographic ImmunoassayReal-Time PCR (qPCR)

ChromaTan Inc. develops single-use, column-free continuous chromatography platforms for bioprocessing. Its Kascade™ BioRMB™ system uses true moving bed technology and multi-stage countercurrent extraction to enable intensification and continuous purification of sensitive biological modalities such as gene therapy products, fusion proteins, DNA, and mRNA. The company was named the 2024 Bioprocessing Summit Best of Show People's Choice Awards grand prize winner.

continuous chromatographymulti-stage countercurrent extractionprocess developmentsingle-use disposable flowpathtrue moving bed technology

CONTINUUS Pharmaceuticals develops Integrated Continuous Manufacturing (ICM) technology that replaces months-long batch processes with a single continuous flow transforming raw materials into active pharmaceutical ingredients (APIs) and final dosage forms in days. The company offers fully integrated process and formulation development services spanning from API synthesis to final dosage form, and provides modular, plug-and-play unit operations.

coatingcontinuous crystallizationcontinuous dryingcontinuous filtrationcontinuous formulationcontinuous solvent recoveryflow chemistryformulation developmentgranulationhot melt extrusioninjection moldingprocess analytical technology (PAT)process developmenttableting

Copperhead Chemical Company® Inc. is a manufacturer of pharmaceutical-grade nitroglycerin (glyceryl trinitrate) and diluted nitroglycerin mixtures for cardiac therapy, energetic materials for propellants, fuel additives and munitions, and plant-based preservative and cosmetic ingredients. Its FDA-registered Tamaqua, PA facility operates under GMP and Process Safety Management, and the company offers custom manufacturing and custom synthesis.

blendingcustom analytical workCustom Manufacturingcustom synthesislab-scale custom synthesisnitration of glycol estersscreening and testingTechnical Support

CPC Scientific is a CDMO specializing in peptide and oligonucleotide production, supporting research-grade discovery, clinical-grade API peptide CMC development, and commercial manufacturing for pharmaceutical and biotech companies. With 25 years of expertise, it offers custom peptide synthesis, GMP peptide manufacturing, oligonucleotide manufacturing, and peptide-oligonucleotide conjugate services. Its Hangzhou-based cGMP manufacturing facility has completed a US FDA Pre-License Inspection.

custom peptide synthesislarge-scale manufacturingoligonucleotide manufacturingpeptide modificationspeptide-oligonucleotide conjugationsolid-phase peptide synthesis (SPPS)

Curia is a global contract research, development and manufacturing organization (CDMO) with over 30 years of experience guiding clients through drug discovery, development, and manufacturing. It offers services across Small Molecule, Generic APIs, Sterile Drug Product, and Biologics, operating an integrated network of 20+ facilities and 3,000+ professionals across North America, Europe, and India.

analytical testingantibody discovery and engineeringchemical process R&Ddownstream process developmentdrug discoveryfermentationflow chemistryhigh potency API (HPAPI) manufacturingLNP formulationmammalian cell line developmentmRNA process developmentrecombinant antibody productionrecombinant protein productionsterile API manufacturingupstream process development

Dompé farmaceutici S.p.A. is a global biopharmaceutical company founded as Milan's first compounding pharmacy and grown over 130 years. It straddles primary care and biopharma, harnessing nerve growth factor (NGF) to develop first-in-class disease-modifying therapies across ophthalmic, neurological and pain-related indications. It engineered and manufactured the first recombinant human nerve growth factor (rhNGF) and developed the Exscalate virtual screening platform.

biotech manufacturingclinical trialsrecombinant human nerve growth factor (rhNGF) engineeringResearch and Developmentvirtual screening (Exscalate)

Drug Discovery Alliances provides a pharmaceutical R&D platform backed by an integrated team of CMC consultants and a global network of preferred suppliers, driving programs from discovery phase to commercialization. Founded in 2001 by Deborah Minor, Ph.D., the company supports biotech and pharmaceutical companies with drug discovery, drug development, CMC consulting, and regulatory support.

analytical method developmentantibody manufacturingAPI manufacturingcatalysis screeningCMC consultingcrystallizationformulation developmentGMP auditingIND application preparationmedicinal chemistrypreclinical developmentprocess researchregulatory supportsolid form screening

E&D Herbs Medicine Natural Products is a family-owned business in Moca, Puerto Rico that produces natural herbal products, including liquid extracts, tinctures, oils, capsules, creams, and teas. Products are manufactured artisanally under Puerto Rico Department of Health standards and GMP (Good Manufacturing Practice). The company organizes its herbs by body systems and health conditions.

artisanal manufacturingclassic extraction methods

Expression Systems, an Advancion company headquartered in Davis, California, supplies and services the baculovirus, cell culture and bio-industrial markets with cell culture media formulations, cell lines, molecular tools, reagents, and contract manufacturing services. Founded in 1997, the company specializes in the baculovirus expression vector system (BEVS) and insect cell culture, offering products and services from gene optimization to protein purification.

baculovirus stock productionbaculovirus titeringcell culture media manufacturingcodon optimizationcontract manufacturinggene synthesismolecular biologyplasmid scale up and purificationprotein productionprotein purificationvector design and cloning

Expression Therapeutics is a clinical-stage biotechnology company pioneering a curative stem cell therapy for hemophilia A and best-in-class cell therapies for neuroendocrine tumors (NETs). Its work is powered by proprietary AI-based technological breakthroughs and an integrated 43,000 sq ft GMP manufacturing facility in Cincinnati, Ohio.

cell therapy manufacturinggene therapy developmentGLP labslentiviral vector engineeringmodular cleanrooms