Contract Services
EXECUTIVE INTERVIEW - Battelle: Innovation in Drug Delivery Through Integrated Science & Engineering
Drug Development Executive: Amy Heintz, PhD, Senior Research Scientist at Battelle, speaks about the company’s relationship with customers and the importance of integrating device design, formulation, and human factors in the development of safe and efficient drug delivery solutions.
MANAGEMENT INSIGHT - Six Reasons Why the Affordable Care Act May Be a Bad-Tasting Medicine That Could Heal Our Industry
Derek Hennecke says that whether you love the Affordable Care Act (ACA) or abhor it, the fact is, there are billions of dollars of government money in play and some industries are going to benefit tremendously.
EXECUTIVE INTERVIEW - Aptar Pharma: From Self-Injection to Auto-Injection
Pierre Carlotti, Vice-President of Marketing and Communication for Aptar Pharma Prescription Division, talks about the market for auto-injectors and some relevant market trends, and explains how his company went about designing and developing a novel auto-injector.
BIOAVAILABILITY ENHANCEMENT - Navigating a Broad Spectrum of Solubilization Technologies: Part III of III
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., concludes his multiple-part series discussing today’s most challenging issues in solubility.
EXECUTIVE INTERVIEW - Catalent Applied Drug Delivery Institute: Helping to Get Better Drugs to Waiting Patients, Encouraging the Adoption of Advanced Delivery Technologies
Drug Development Executive: Kurt Nielsen, PhD, CTO & SVP, Innovation & Growth, and Founding Institute Board Member, discusses the Institute, its goals, structure, and activities.
MANAGEMENT INSIGHT - Up Against the Wall: What You Need to Know Before Digging Into Your Next Building Expansion
Derek G. Hennecke continues his series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
MARKET BRIEF - Financial Performance Benchmarking & Competitive Landscape Assessment of Leading CROs
Adam M. Dion, MS, summarizes GlobalData’s recent CRO Benchmark Report and believes the dynamics of pharmaceutical outsourcing and location decisions in emerging markets are changing. Cost reduction is being augmented and will gradually be eclipsed by footprint growth as a major factor shaping decisions, and CROs are realizing that the ability to be on the ground closer to their customers is a key building block to establishing sustainable, long-term relationships with clients.
PACKAGING SOLUTIONS - Overcoming the Challenges of Child-Resistant/Senior-Friendly Closure Development in Today’s Changing World
Steve Stalions and Kurt Attermeier say that as the demand for better CR/SF packaging is on the rise, so too is the market demand for greater cost effectiveness, sustainability, and value-added end-user benefits, and explain how these challenges can be overcome.
SPRAY-DRIED DISPERSIONS - Efficient Scale-Up Strategy for Spray-Dried Amorphous Dispersions
Devon DuBose, Dana Settell, and John Baumann focus on the methodologies for efficient scale-up of the spray-drying process while maintaining the critical-to-quality attributes of the SDD.
BUSINESS DEVELOPMENT - Growing Your Business: A Stage-by-Stage Analysis of Your Company’s Growth & the Challenges it Faces
Derek G. Hennecke continues his series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
EXCLUSIVE ONLINE CONTENT
PCI Pharma Services Begins Installation of Sterile Fill-Finish & Lyophilization Line as Part of $100-M New Facility Expansion
PCI Pharma Services has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, NH campus. Twin lyophilizers and a state-of-the-art large-scale isolator….
Adare Expands Global High Potency Handling & Packaging Capabilities
Adare Pharma Solutions, a global technology-driven CDMO specializing in oral dosage forms, recently announced expansions of its high potency handling capabilities in the….
Lonza Launches AI-Enabled Route Scouting Service to Accelerate Small Molecule Development
New advanced technology-enabled offering aims to streamline synthetic route identification for novel active pharmaceutical ingredients (APIs)….
Abzena Launches Next-Generation Immunogenicity Tool for De-Risking the Development of Complex Biologics & Bioconjugates
Abzena recently announced the launch of its enhanced bioassay platform EpiScreen® 2.0, a comprehensive suite of assays that predict and evaluate potential risks of preclinical immunogenicity in protein….
Biolojic Design Announces Nektar Therapeutics Has Exercised its License Option to Develop an AI-Designed Agonistic Antibody Targeting TNFR2 for the Treatment of Autoimmune Diseases
Program is the Product of a Research Collaboration between Biolojic Design and Nektar entered in 2021….
MARKET NEWS & TRENDS
WEBINARS
WEBINAR - 2024 Trends in Topical Drug Delivery: Insights & Innovation
This webinar will discuss some of the key trends from these leaders in the topical market on both a global and regional level, including the increased importance of sensory properties and the rise in non-conventional product formats, among others…..
WEBINAR - Enabling Upstream Intensified Bioprocessing
Intensified upstream bioprocesses are being developed to increase productivity while reducing footprint, costs, and timelines for manufacturing. The higher cell densities generated by….
WEBINAR - Nanoparticle Suspensions: History, Applications & CMC Aspects
This webinar describes the history, CMC aspects, and potential applications of nanoparticle suspensions (NSs). This drug delivery technology should be considered for crystalline, sparingly water-soluble APIs. The presentation highlights….
WEBINAR - Impact of Process Re-design on Sustainability in Pharmaceutical Small Molecule Manufacturing
Join us for an upcoming webinar that delves into a crucial issue in the pharmaceutical industry. Recent research has revealed a surprising fact: the pharmaceutical sector has a larger carbon footprint than even the automotive industry, especially when we consider the entire supply chain’s impact on
ON-DEMAND WEBINAR – Solve Common Design Challenges in Inhalation Devices With Porous Polymers
The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices….
WHITE PAPERS
WHITEPAPER - Continuous Flow - An Emerging Alternative
In the whitepaper Continuous Flow: An Emerging Alternative, Curia experts discuss how continuous flow chemistry and processing offer an alternative pathway. The paper explores its….
WHITEPAPER - 3 Key Things to Consider When Choosing a Partner for Your Tech Transfer
One way of streamlining tech transfer is to partner with a CMO demonstrating a proven track record across the entire drug development and manufacturing continuum. Not only will an experienced CMO partner have the scientific ,,,,
WHITEPAPER - Manufacturing of 10-mg Loratadine Self-Emulsifying Drug Delivery System (SEDDS) Tablets by Direct Compression With ABISORB-DC & ABISOL Emulsion Preconcentrate Kit
10-mg loratadine SEDDS were successfully manufactured with ABISORB-DC(TM) and ABISOL(TM) 2 by direct compression on a rotary tablet press, employing standard pharmaceutical manufacturing equipment…..
WHITEPAPER - Revolutionizing Small Molecule API Production: Unveiling the Impact of Fermentation as a Sustainable Solution
While large molecules continue to advance in drug development pipelines, small molecule Active Pharmaceutical Ingredients (APIs) still retain their historical dominance among new drug applications…
WHITEPAPER - Minimizing API Supply Chain Risks
By the time your API is brought to a contract manufacturing organization (CMO), you have already put extensive amounts of resources into developing it. It becomes essential….
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.