Contract Services
Elizabeth Hickman to Succeed Tim Scott as AustinPx CEO
AustinPx, developers of the next generation amorphous dispersion platform, KinetiSol Technology, and a contract development and manufacturing organization (CDMO), recently announced Elizabeth Hickman, Chief Business Officer, will succeed….
One of Northern Europe’s Largest Production Sites Successfully Taken Over by the Prange Group & Adragos Pharma
The Prange Group and its affiliate Adragos Pharma, one of Europe’s fastest growing CDMOs, has completed the acquisition transaction of Fresenius Kabi production site in…
SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest
Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.
DRUG DELIVERY - EUDRACAP® Select - Examining a Case From Development to Clinical Trial
Lucas Paulo Cusin, Kamlesh Oza, PhD, and Steven Smith, et al focus on the development of a customized functional coated capsule for the delivery of live biotherapeutics and demonstrate its effectiveness in the oral delivery of a sensitive proprietary microbiome ecosystem while simplifying the drug development process.
DRUG DEVELOPMENT EXECUTIVE - Thermo Fisher Scientific: What to Expect From the Next Wave of RNA-Based Therapeutics
Dr. Dale Patterson, Vice President and General Manager, Molecular Biology at Thermo Fisher Scientific, delves into the world of RNA therapies and understand their next act beyond COVID-19.
PBPK MODELING - Critical Parameters for Simulating Oral Absorption Using PBPK Models
Deanna Mudie, PhD, says with an increasing number of drugs posing absorption challenges, the ability to predict how a new molecule will behave in vivo is important, and being able to predict and mitigate absorption problems before they arise should help the project progress with fewer delays.
PREFILLED SYRINGES - Making a Prefilled Syringe Smart: Technological Solutions to Advance Patient Care & Clinical Trial Outcomes
Salvatore Forte, MS, believes adherence to the dosing regimen, as well as compliance to the injection protocol, are essential for treatment success in both these use-cases. Hence, the request for a connected, smart PFS is growing just as much to tackle poor medication adherence and compliance issues.
CLINICAL TRIALS - Digital Endpoint Integration in Clinical Trials: Key Considerations & Nuances Per Therapeutic Focus
Tapan Raval and Ganesh Gundi, MD, say enhancing the patient experience and reducing burden is key in today’s drug development landscape, and DHTs can certainly play a positive role in that.
DATA-SHARING PLATFORM - How to Overcome the Challenge of Differing Digital Maturity Levels in Biopharmaceutical Supply Chains
David Brick, MS, and Harlan Knapp, MS, review how the efficient and timely delivery of therapeutics with complex manufacturing needs cannot be achieved by simply unifying the entire pharmaceutical landscape within the most advanced digital maturity level. A better approach is to implement a flexible data-sharing platform that can accommodate partners with different data management capabilities.
BioCina & NovaCina Forge Strategic Alliance to Offer Biologics Developers Integrated Drug Substance & Drug Product Solutions
BioCina Pty Ltd. and NovaCina Pty Ltd. recently announced a strategic partnership to provide integrated drug substance and drug product solutions for….
Simtra BioPharma Solutions Announces $250+ Million Investment to Expand Sterile Fill/Finish Manufacturing Site
Simtra BioPharma Solutions recently announced a $250+ million expansion of its sterile fill/finish manufacturing campus in Bloomington, IN….
ABVC's New Horizon for Oncology & Hematology Aims at Cancer Market of Several Hundred Billion Dollars
ABVC BioPharma, Inc. recently provided an update on its development of combination therapy for the treatment of cancer and immunity booster dietary supplements. The company is currently marketing….
Curia Appoints New Vice President, Biologics
Curia recently announced it has appointed Steve Lavezoli as Vice President of Biologics effective February 26. Lavezoli will lead Curia’s biologics division, overseeing its discovery,…
Jubilant HollisterStier Opens Third Manufacturing Line
Jubilant HollisterStier recently celebrated the opening of its third sterile fill finish manufacturing line and broke ground on the next phase of its facility expansion in Spokane, WA…..
Aptar Digital Health Announces Acquisition of Healint to Reinforce Digital Health Portfolio & Drive Future Growth
Aptar Digital Health recently announced it has acquired Healint, a digital health company recognized for their virtual clinical studies, real-world evidence and patient registries platform,…
Cresset Announces Global Collaboration With Enamine on New Virtual Screening Drug Discovery Technology
Cresset recently announced a collaboration with Enamine, the world’s leading provider of chemical building blocks and drug discovery services to develop innovative….
Vaccinex Announces Multiple New Agreements for Access to ActivMAb Antigen Virus Technology
Vaccinex, Inc. recently announced it has entered into eight new antibody discovery agreements integrating use of its proprietary ActivMAb platform to select antibodies against difficult-to-drug…
Dyadic Advances Collaboration With Israel Institute for Biological Research Targeting Bio-Threats & Emerging Disease Solutions
Dyadic International, Inc. and Israel Institute for Biological Research (IIBR) recently announced it has advanced its collaboration with IIBR and its commercial arm Life Science…
Selkirk Pharma Announces New APS Qualified Facility With Advanced Fill/Finish Capacity in Spokane, WA
Selkirk Pharma, Inc. recently announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity. This development marks a…
PathAI Announces Exclusive Collaboration With Roche Tissue Diagnostics to Advance AI-enabled Interpretation for Companion Diagnostics
PathAI, Inc. recently announced an expanded and exclusive relationship with Roche Tissue Diagnostics (RTD) that will bring AI-enabled interpretation to companion diagnostics. Building upon the success…
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.