Contract Services
Kindeva Opens New UK HQ & Manufacturing Site for the Development of Next-Generation Propellants
Kindeva, a global CDMO and drug delivery expert, has officially opened its new UK headquarters at Charnwood Campus Science Innovation and Technology Park, Loughborough. The…
Cellares Selects Five Best-in-Class Technology Providers to Expand Cell Q’s Capabilities in Meeting Demands for Commercial Scale Cell Therapy Quality Control
Cellares, the first Integrated Development and Manufacturing Organization (IDMO), recently announced multiple strategic technology partnerships to advance the Cell Q, the first fully automated quality…
Gerresheimer Expands Collaboration With Portal Instruments for Commercialization of the PRIME Nexus Reusable Autoinjector
Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries today announced that it will further expand…
Sharp Invests $20 Million in Autoinjector & Pen Assembly Lines to Meet Rising Demand for Injectables
Sharp Services, a leader in pharmaceutical packaging, clinical trial services & sterile manufacturing, has announced a $20 million investment in its autoinjector and pen assembly,…
Upperton Wins Pharma Contract Services Company of the Year at the Pharma Industry Awards UK 2025
Upperton Pharma Solutions has added another impressive award to a growing list of achievements, winning the award for Pharma Contract Services Company of the Year…
Symeres Acquires DGr Pharma to Enhance Regulatory Expertise & Broaden Biopharma Capabilities
Symeres recently announced the acquisition of DGr Pharma, a drug development-focused consultancy, to expand its integrated early-stage drug development services and accelerate IND-enabling capabilities for…
SPECIAL FEATURE - Injection Devices: Faster, Integrated, and Flexible for the IV to SC Transition
Contributor Cindy H. Dubin speaks with several companies who highlight how device developers are addressing various challenges while still ensuring precise dosage control and patient compliance.
Biosplice Therapeutics Announces First Patient Dosed in NCI-Sponsored Clinical Trial of Cirtuvivint in AML & Myelodysplastic Syndromes
Biosplice Therapeutics, Inc. recently announced the first patient has been dosed in a Phase 1 clinical trial of cirtuvivint in patients with acute myeloid leukemia…
Lilly Launches TuneLab Platform to Give Biotechnology Companies Access to AI-Enabled Drug Discovery Models Built Through Over $1 Billion in Research Investment
Eli Lilly and Company recently announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug…
SUBCUTANEOUS INJECTIONS - A New Dimension for an Enhanced Injection Experience
Enrico Barichello and Crystal Salvans explore the impact of market trends, focusing on the technical and clinical challenges associated with delivering large-volume, high-viscosity subcutaneous injections. They also highlight the need for optimized delivery systems that can accommodate these formulations without compromising usability or efficacy, as well as the potential advantages such systems may offer for non-viscous injections.
FORMULATION FORUM - Hot Melt Extrusion – An Enabling Technology for Poorly Soluble Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say in spite of many challenges, drug manufactures continue to look for non-conventional, and often novel, polymers to expedite the development of innovative molecules coming out of discovery when none of the conventional technologies do not meet the desired objectives.
PULMONARY DELIVERY - Development of Pulmonary Dosage Forms for the Successful Delivery of Complex Molecules
Richard Johnson, PhD, believes there is growing interest in next-generation pulmonary delivery devices that can overcome delivering drugs more efficiently into the deep lung and also delivering thermally sensitive drugs that are unstable in solution.
EXECUTIVE INTERVIEW - Lonza & Ethris: Advancing mRNA Vaccines: Room-Temperature Stable, Spray-Dried Formulations for Enhanced Mucosal Delivery
Kim Shepard, Director of Advanced Drug Delivery at Lonza, and Carsten Rudolph, PhD, Co-founder and Chief Executive Officer at Ethris, discuss the main objectives of the collaboration and the benefits of spray-dried mRNA vaccines.
STERILE INJECTABLE MANUFACTURING - Solving Complexity & Strategies for Commercial Success
Jennifer Gattari explores the key forces driving change in the SI space and outlines the core considerations manufacturers must address to deliver safe, effective therapies at commercial scale and the growing reliance on contract manufacturers to help navigate complexity with confidence.
LIPID SOURCING & SELECTION - Navigating the Lipid Landscape: Overcoming the Challenges of Lipid Sourcing & Selection for LNPs
Donald Kelemen, PhD, says one of the most significant challenges lies in selecting and sourcing the molecules at the heart of LNPs: lipids. The right choices can optimize stability, efficacy, and scalability, while the wrong ones can introduce roadblocks that are difficult (and costly) to overcome.
Thermo Fisher Scientific Introduces Next-Generation Unmixing Beads to Enhance Accuracy & Performance in Spectral & Conventional Flow Cytometry
Thermo Fisher Scientific has introduced Invitrogen™ UltraComp eBeads™ Spectral Unmixing Beads to improve accuracy in spectral and conventional flow cytometry. These beads help researchers more…
2025 Analytical Testing e-Book - New ICH Guideline Outlines E&L Principles
In this exclusive Drug Development & Delivery e-book, Stevanato Group discusses E&L from the perspective of lyophilized products, common E&L testing challenges, how to mitigate testing risks.
Quotient Sciences & CPI to Accelerate RNA Drug Development With Joint Venture
Quotient Sciences, a leading global drug development and manufacturing accelerator, and UK technology innovation centre, CPI, have signed a memorandum of understanding (MoU) to form…
OMass Therapeutics Enters Exclusive Collaboration & License Agreement With Genentech
OMass Therapeutics recently announced it has entered into an exclusive collaboration and license agreement with Genentech for the rights to develop and commercialize OMass’ preclinical…
Bio-Rad Expands Range of StarBright Dyes to Enhance Panel Design Capabilities for Spectral Flow Cytometry
Bio-Rad Laboratories, Inc. recently announced the introduction of a new range of StarBright Dyes, providing greater choice and flexibility for spectral flow cytometry in immunology…
Contract Services Market Overview
Increasing patent expirations of major drugs, the growing burden of chronic diseases, and elevated global awareness of vaccines are leading to a surge in outsourcing formulation development services. Industry experts say these trends put a value on the global pharmaceutical CDMO Market at $160.12 billion in 2020, and could reach $236.61 billion by 2026, while the North American CDMO market is expected to reach $101.1 billion by 2030. As more pharma/biopharma companies opt to partner with CDMOs, much of this activity is occurring in the early phase of development with the goal of overcoming risk, along with saving time and money as a drug passes through the development pipeline.
Sectors of the CDMO market – sterile injectables, prefilled syringes, biologics APIs, and viral vectors – are expected to expand quickly, driven by an accelerating shift in the pharmaceutical market toward innovative biologic and cell and gene therapy products. Nonetheless, small molecules will continue to represent the majority of prescribed drugs for the foreseeable future and thus are the major growth driver for the CDMO market.
Who Uses Contract Services?
Experts see a strong correlation between size of a company and its likelihood to outsource. In 2017, manufacturing of 20% of newly approved drugs was outsourced by Big Pharma; this increases to 80% of all manufacturing being contracted out by small biotech/pharma. And all 15 newly approved drugs in 2017 owned by small companies were supplied by CDMOs.
Rare diseases, fast-tracked drugs, and oncology treatments now account for much of pharma’s development pipeline, so it is important that CDMOs provide specialized capabilities, technology, expertise, and experience relevant to these types of programs. For expedited pathways, it is important, too, that development partners understand the interwoven and related steps essential to progressing a program efficiently and quickly. To that end companies have invested in technology and capabilities such as hot melt extrusion, spray-dry dispersions, and lipid formulation to provide options for small-molecule development, often to address the all-too-common hurdle of poor solubility and bioavailability.
How to Work with Contract Service Providers
Getting a CDMO engaged in the development process as early as possible avoids spending time exploring the wrong solutions and coming up with suboptimal formulations that need to be corrected before manufacturing. By bringing a CDMO in earlier in the process, they can more accurately assess which technologies and approaches can work on a project.
As drug products become more complex, there is increasing customer demand for relationships with CDMOs that have core competencies in highly specialized formulation and process technology areas.
One of these specialty areas is complex molecules. Biotech companies developing novel biologics are increasing in the market, thus there is an increase in outsourcing development services to BioCDMOs. To serve the needs of this market, companies are expanding their bio capabilities to offer advanced manufacturing technologies.
Another area of expertise where pharma is relying on CDMOs is in cell and gene therapy. Industry insiders expect gene therapy manufacturing market to boom and grow at rates ranging from 15 to 20%. Benefits of partnering with a cell or gene therapy CDMO include scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies. Demand for specialized manufacturing and clinical trial support for cell and gene therapies has resulted in more than 40 companies offering these services.