Contract Services
DRUG DISCOVERY – Getting the Most From a DNA-Encoded Library Screen
Matthew A. Clark, PhD, says despite this high level of interest, there remains variable understanding of how to maximize the potential of a DEL screen, and shares his company’s approach to DEL screening and how its partners get the most from this powerful technology.
NANOPARTICLE ENGINEERING – Lighting the Way to a Patient-Centric Future
Christopher Worrall, PhD, discusses how nanoparticle engineering technologies could help improve compliance and patient outcomes, for both small-molecule and biological drugs, and how nanotechnology can help facilitate a shift toward more patient-centric medicine.
ON-DEMAND WEBINAR – CMC Strategy to Take Bispecifics From DNA to IND in 13 Months* by Lonza
Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation….
WHITEPAPER – Extrusion-Spheronization, Engineered for Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization (E-S) offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics.
WHITEPAPER – Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
SPECIAL FEATURE – Injection Devices: Three Trends Influencing Development & Delivery
Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.
GENERATIVE AI TECHNOLOGY – Generative Machine Learning Can Construct Smooth Chemical Search Spaces for Efficient Drug Discovery
Jason Rolfe, PhD, and Ali Saberali, PhD, and Mehran Khodabandeh, MSc, explain how Generative ML promises to efficiently optimize more accurate estimates of binding affinity and other pharmacological properties over the entirety of drug-like chemical space.
EXECUTIVE INTERVIEW – Emergent CDMO: A Molecule-to-Market Partner for Complex Biologics
Bill Hartzel, Senior Vice President and Head of CDMO Business, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
DRUG DEVELOPMENT STRATEGIES – Marrying Target Product Profile, Regulatory & Partnering Strategies for Long-Term Product Success
Chris Rojewski believes given the costs, time, and risks associated with contemporary drug development, it’s time this fundamental aspect of successful development be brought as close to the program as possible — the CDMO tasked with executing drug strategy in the first place.
2022 Analytical Testing eBook – Service Providers Offer Innovation
Learn more about the technologies from Alcami, Associates of Cape Cod, Stevanato Group, and West in this exclusive 2022 Drug Development & Delivery Analytical Testing e-book.
EXCLUSIVE ONLINE CONTENT

Gerresheimer & Corning Announce Joint Venture to Meet Growing Demand for Velocity® Vials, Accelerating the Delivery of Life-Saving Treatments
The partnership will combine Gerresheimer’s extensive glass converting expertise with Corning’s Velocity® Vial technology platform, helping set a new standard for the industry….

Pantherna & Evaxion Announce Promising Preclinical mRNA Vaccine Data
Evaxion Biotech A/S and Pantherna Therapeutics GmbH recently announced preclinical proof of concept for the combination of the two companies’ key….

Stevanato Group Collaborates With Transcoject to Provide Pre-Fillable Syringe Polymer Options for Pharma
Leading drug containment provider to release a unique offering including both COP and COC pre-fillable syringes (PFS), adding to its existing glass PFS portfolio, providing customers with the broadest choice for PFS….

X-Chem & Kymera Expand Existing Partnership
X-Chem recently announced the expansion of its collaboration with Kymera Therapeutics, Inc. With the expanded agreement, X-Chem will serve as the primary provider of DNA-encoded….

Start-Up Innovation at Pharmapack 2023
Pharmapack Europe 2023 returns to its traditional February timing for the first time since the start of the pandemic and provides the industry with a vital early window into many of tomorrow’s technologies that improve patient experience, adherence, and delivery…..
MARKET NEWS & TRENDS
WEBINARS

ON-DEMAND WEBINAR – CMC Strategy to Take Bispecifics From DNA to IND in 13 Months* by Lonza
Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation….

WEBINAR – Getting to the Core of Pellet Coating
This webinar is part of The future of solid dosage, an ACG 360 webinar series covering wide-ranging, simple, and transformative ways to achieve smarter pharma formulation, manufacture, and packaging.

On-Demand Webinar: How to Safely Handle Your Antibody Drug Conjugate
Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications…..

WEBINAR: BPOG 2020 & USP 665 – Extractables Testing of Single-Use Systems
This webinar will explore how to conduct effective extractables and leachables (E&L) testing on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing…..

On Demand Webinar – Emergent CDMO: High-Speed Manufacturing Solutions for Your Viral Vaccine or Therapeutic
Emergent and groniger partner to present the benefits and features of the INTEGRA® high-speed aseptic fill line with isolator technology for viral vaccines and therapeutics.
WHITE PAPERS

WHITEPAPER – Case Study-Improving Bioavailability Using PBPK Modeling & Parallel Formulation Screening
A team of bioavailability experts at Catalent used the in-house bioavailability enhancement platform, OptiForm® Solution Suite, to optimize and develop….

WHITEPAPER – Maintaining Sustainable Business Practices During the Energy & Supply Crisis
As we come to the end of another year, our global economy faces many significant challenges. Recently, a colleague asked me, “As a biopharma executive, which of today’s major issues are the ones that keep you up at night?”

WHITEPAPER – Accelerated API Manufacturing by Combining Early-Stage and Late-Stage Process Development
Traditionally, early-stage and late-stage process development have been done separately, with early-stage mostly focused on material production and late-stage on process intensification. As more….

WHITEPAPER – Extrusion-Spheronization, Engineered for Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization (E-S) offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics.

WHITEPAPER – Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
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.