Contract Services
CYBERSECURITY - Why Pharmaceutical Companies Are Vulnerable to Cyberattacks & What You Can Do to Protect Your Company
Andrew Douthwaite says having a comprehensive cybersecurity strategy in place to safeguard digital assets has become an essential part of any company’s security protocols, and not doing so leaves valuable data vulnerable.
Catalent Completes Purchase of Biologics Fill-Finish & Oral Solid Dose Facility in Anagni, Italy
Catalent recently announced the completion of the purchase of Bristol-Myers Squibb’s biologics, sterile, and oral solid dose product manufacturing and packaging facility….
WuXi STA Opens Oligonucleotide Large-Scale Manufacturing Facility
STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – recently announced the opening of its large-scale oligonucleotide active pharmaceutical ingredient (API)…
Catalent Launches New CTSuccess(TM) Service to Guide Sponsors to Smarter Clinical Trial Supply Planning
Catalent, a global leader in clinical supply services, recently announced the launch of its new CTSuccessTM clinical trial planning service, designed to support trial sponsors…
Appili Therapeutics Enters Commercial Agreement With Saptalis Pharmaceuticals
Appili Therapeutics Inc. recently announced it has entered into a commercialization agreement with Saptalis Pharmaceuticals LLC on ATI-1501, Appili’s liquid suspension reformulation of the…..
Vivera Pharmaceuticals Enters Agreement Clinical Study Agreement With Parexel Biotech
Vivera Pharmaceuticals, Inc. recently announced it has signed an agreement for Clinical Development Services with Parexel International, a leading provider of solutions to accelerate the…
PPD Expands Special Patient Capabilities in Early Development Research
PPD, Inc. has expanded its early development research services by adding significant neuroscience and ethno-bridging expertise, broadening its capabilities to provide increased access to…..
Recipharm Announces Commercial Manufacturing to Support Drug Launch Following FDA Approval
Recipharm, the contract development and manufacturing organisation (CDMO), recently announced ongoing large-scale commercial manufacturing of RedHill Biopharma’s drug, Talicia (omeprazole magnesium,…..
Yourway Announces Opening of New Wholly Owned Depot in India
Yourway, the only truly integrated premium courier and clinical packager in the industry, announced its establishment of a new depot in Mumbai, India. While Yourway…
Inceptua & Bendalis Enter Exclusive Agreement
The global pharmaceutical company and service partner Inceptua Group (previously Multipharma GmbH) and Bendalis GmbH – German manufacturer of generic oncology drugs and special therapeutic…
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
CDMO SELECTION - Ready to Launch: Developing Your Biologic With an Eye Toward Commercial Supply
Stacey Treichler, PhD, believes the development process for new biologics is complex and requires a substantial amount of time and resources, and reviews some of the areas where careful choice of CDMO is key, including cell line development and cGMP manufacturing capabilities, and how an integrated approach can be beneficial.
PREFILLED SYRINGES - Selecting the Right Primary Container for Injectables in Acute Care
Alfred Harvey, MBA, MS, discusses how differences in primary container options for injectable drugs can add value by offering hospitals and care centers configurations that address universal pain points.
CONTINUOUS MANUFACTURING - Continuous Manufacturing in Pharmaceuticals: Implications for the Generics Market
Kamna Jhamb, PhD, says the highly regulated nature of the pharmaceutical sector, and the low-risk-taking nature of this market, are the two main factors that have restrained the implementation of novel methods of manufacturing by pharmaceutical industries. However, the burgeoning demand for complex and innovative therapies and rising competition have led pharmaceutical manufacturers to reconsider their methods of manufacturing.
Catalent to Supply BeiGene's BTK Inhibitor BRUKINSAT
Catalent recently announced it had entered into a long-term commercial supply agreement with BeiGene, Ltd., a biopharmaceutical company focused on developing….
Hovione Technology Completes Pilot-Scale Blister Manufacturing for the Papillon DPI
Hovione Technology recently announced it has completed pilot-scale blister manufacturing and filling for its new reusable blister-based dry powder inhaler, the Papillon DPI. Papillon targets…
Cytel Acquires MTEK Sciences, Further Expanding Advanced Real-World Analytics Capabilities
Cytel Inc. recently announced that it has acquired MTEK Sciences to further expand its advanced real-world analytics (RWA) capabilities….
New Study From Tufts Center for the Study of Drug Development Establishes Benchmarks
While more than 90% of all contract vendor assessments conducted by drug sponsors ultimately lead to vendors being qualified to provide services, large sponsors have…
Centogene Signs Collaboration Agreement With Pfizer
CENTOGENE recently announced a new data access and collaboration agreement with Pfizer Inc. The agreement grants Pfizer access to CENTOGENE’s data repository, which may be…
Vetter’s US Site Offers Clinical Manufacturing for Successful Drug Development of Injectables
Pharma and biotech companies, both large and small, have high expectations for their new molecules they have in development. Even the smallest of details can impact the eventual success or failure of their product…..
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.