Pre Clinical Development
FEATURED ARTICLES
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Accelerated Drug Development: The Promise Is In The Process
In 1993, the FDA issued the call to the pharmaceutical industry to streamline the drug development process from discovery to First In Man. By Jan-Olav Henck, Ph.D., Chief Scientific Officer, Aptuit LLC
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Brochure: Biologics Contract Manufacturing & Technology Solutions
DSM provides turn-key biologic manufacturing solutions, contract manufacturing for preclinical development, clinical trials or commercial supply and reduced cost, risk, and time to market.
SUPPLIER PROFILES
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UPM Pharmaceuticals, Inc.
UPM Pharmaceuticals, Inc. is a Baltimore-based, independent drug development and contract manufacturer serving the pharmaceutical and biotechnology industries.
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Aptuit
Aptuit is a pharmaceutical services company that delivers early to mid-phase drug development solutions by applying scientific excellence, outstanding service and a team of some of the foremost scientific professionals in the industry.
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Cedarburg Hauser Pharmaceuticals
Cedarburg Hauser Pharmaceuticals is an experienced, contract development and manufacturing organization (CDMO), specializing in small molecule active pharmaceutical ingredients (API) and pharmaceutical intermediates. Cedarburg Hauser leverages a talented group of scientists and supporting staff, as well as a centralized approach to project management, to ensure on-time and on-budget completion of projects involving the development, scale-up, and manufacturing of complex APIs.
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Analytical Bio-Chemistry Laboratories (ABC Labs)
When developing drugs, we all know that sound, regulatory-compliant science is a must-have. But at Analytical Bio-Chemistry Laboratories, we understand that it’s the business side—the processes, the systems, the communication—that make or break a CRO-sponsor relationship.
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Aptuit, Inc. - drug development programs, pharmaceutical service Aptuit is a pharmaceutical service company that conducts research, development and manufacturing on a contract basis for both large and small innovators.
OUTSOURCED PHARMA NEWS
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Made Scientific Selected As Manufacturer For Columbia University's Autologous And Allogeneic NOVAKnee Program - A First-In-Class Living Biologic Total Knee Replacement6/5/2026
Made Scientific, Inc., a leading U.S.-based clinical- and commercial-stage cell therapy contract development and manufacturing organization (CDMO), today announced it has been selected as manufacturer for NOVAKnee, a first-in-class living biologic total knee replacement being developed by researchers at Columbia University's School of Engineering and Vagelos College of Physicians and Surgeons under the Advanced Research Projects Agency for Health (ARPA-H) Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) program.
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Stipple Bio Enters Multi-Target License Agreement With Lonza To Advance Precision Oncology ADC Therapies6/4/2026
Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), and Stipple Bio, Inc., a private biotechnology company harnessing epitope-level precision to create targeted cancer therapies, today announced a multi-target licensing agreement to support the development of next-generation precision oncology ADC therapies.
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Made Scientific And Pluristyx Launch Integrated iPSC Development & Manufacturing Partnership To Advance Next-Generation iPSC-Derived Cell Therapies6/4/2026
Made Scientific, Inc., a leading U.S.-based clinical- and commercial-stage cell therapy contract development and manufacturing organization (CDMO), and Pluristyx, a leading provider of RUO and GMP induced pluripotent stem cell (iPSC) platform technologies, today announced a strategic partnership to integrate Pluristyx Technology including GMP iPSC lines and derivative cell types, including induced natural killer (iNK) cells and induced mesenchymal stem cells (iMSCs), into Made Scientific's end-to-end CDMO offering for global cell and gene therapy innovators.
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Veranova Appoints Dr. Bob Huang Vice President And General Manager Of West Deptford Site6/3/2026
Veranova today announced the appointment of Dr. Bob Huang as Vice President and General Manager for its West Deptford, New Jersey facility. He will lead site operations, advance strategic growth initiatives, and strengthen manufacturing excellence and customer delivery.
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Rezon Bio Appoints Dr. Ralf Otto As Chief Operating Officer To Support Next Phase Of Growth And Operational Expansion6/3/2026
Rezon Bio, a science-driven European biologics contract development and manufacturing organization (CDMO), today announced the appointment of Dr. Ralf Otto, as Chief Operating Officer (COO) effective June 1, 2026.
ABOUT PRE-CLINICAL DEVELOPMENT
Outsourcing of pre-clinical development services involves both in vitro and in vivo testing with In vitro being doing in test tubes or culture dishes and in vivo being animal testing. These pre-clinical trials are required before advancing a drug candidate to Phase I clinical trials or human testing. Many pharmaceutical and biopharmaceutical companies will utilize a pre-clinical contract research organization (CRO) to provide pre-clinical development and trials.
The main purpose of pre-clinical trials is safety testing to ensure the drug, medical device, diagnostic, or gene therapy will be safe for humans. In pharmacology, pre-clinical testing is concerned with pharmacodynamics (PD), pharmacokinetics (PK), and toxicology. Pharmacodynamics deal with the actions of the drug on the target, whereas pharmacokinetics deal with the actions of the body on the drug. Toxicology testing provides confidence in the safety of the potential drug.
While PD will focus on dosage and potency, PK will study absorption, distribution, metabolism, and excretion (ADME). This is all necessary in pre-formulation and formulation services. Other services common in pre-clinical development include genetic toxicology, analytical chemistry, physical chemistry, and analytical development.