Contract Services
EXECUTIVE INTERVIEW – Adare Pharma Solutions: The Journey to Become a Full-Service Provider
Tom Sellig, CEO at Adare Pharma Solutions, discusses his expectations for Adare and how he can leverage his 30-plus years of pharma experience to put Adare in a competitive position to address complex formulation and development challenges.
FREEZE-DRYING MICROSCOPY – Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
EXECUTIVE INTERVIEW – PCI Pharma Services: Broadening Our Biologics Footprint, Together
Shawn Cain, SVP Development & Manufacturing at PCI Pharma Services, discusses the recent acquisition, the opportunities this presents to Biopharma companies, and the current trends in the sterile fill-finish industry.
MEDICAL DEVICE UX DESIGN – Bridging the Divide Between People & Products: How UX Design Can Improve Medical Device Product Development
Aditya Jagannathan explains how human factors and industrial design can bridge the divide between people and products to maximize the likelihood that new medical devices will be safe and effective for the intended uses, users, and use environments.
AUTOMATION SOLUTIONS – The Future of Lab Tech Will Combine Automation, Accuracy & Agility
Rich Ellson and John Fuller, PhD, say accelerating development comes down to designing and using flexible automation solutions along with smarter instruments and new consumable paradigms to help meet researchers’ needs.
WHITE PAPER – Making Sub-Visible Particles Visible: Innovative Analytical Techniques for Detection & Identification
The demand for complex, often life-saving drug substances such as monoclonal antibodies, interferons, and peptides is on the rise, creating a greater need for innovative delivery mechanisms to administer these new therapeutics. For a variety of reasons, sub-visible particles….
WHITE PAPER: Controlled Synthesis of Lipid Nanoparticles Using the Automated Nanoparticle System
Particle Works’ leading microfluidic technology offers a unique automated nanoparticle generation platform for the production of homogeneous, controllable, and reproducible LNPs….
SUPPLY CHAIN MANAGEMENT- Are Supply Chains Up for the Post-Pandemic Challenge?
John Swift believes each medical device manufacturer will discover different patterns of risk as a result of COVID-19. It is therefore imperative that businesses carry out an in-depth and urgent re-appraisal of their supply chain, as failing to do so may cause commercial damage.
EXECUTIVE INTERVIEW – Syner-G BioPharma: A Track Record of CMC Excellence
Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.
BATCH RELEASE – The Business Case for Reinventing Batch Release
Aparna Seksaria reviews how for pharmaceutical companies — and pharma supply chains — to bring safe, commercial-ready products to market quickly and profitably, and for them to meet growing demand for highly personalized, batch-size-one types of products, it’s critical that they take steps to de-risk and speed up processes like batch release, and do so without compromising quality, safety or the bottom line.
EXCLUSIVE ONLINE CONTENT

Mitsubishi Gas Chemical & BD Have Signed LOI to Discuss Partnership Agreement to Explore New Ways to Advance Biologic Drug Delivery
Mitsubishi Gas Chemical Company, Inc. and BD recently announced they have entered into an agreement to investigate further development of OXYCAPT – an innovation from MGC that integrates….

Owen Mumford Appoints New Director of R&D
Owen Mumford, a global leader in the design, manufacture, and advancement of medical devices recently announced it has appointed….

Kindeva Drug Delivery Announces Collaboration With Synopsys
Kindeva Drug Delivery recently announced a collaboration with Synopsys, Inc. involving the implementation of Synopsys Simpleware automated software solutions to assist in creating….

medmix Drug Delivery (Haselmeier) Launches its First Fully Featured Autoinjector
medmix Drug Delivery introduces PiccoJect, a disposable two-step autoinjector designed for subcutaneous injection. The device is being developed in two variants (PiccoJect 100 and PiccoJect 225) for a standard….

Replicate Bioscience & Curia Enter Strategic Collaboration to Create Groundbreaking Development Platform for Self-Replicating RNA
Replicate Bioscience and Curia, formerly AMRI, recently announced they will collaborate on a robust development platform for Replicate’s srRNA therapeutics. The strategic collaboration unites….
WEBINARS

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.

WEBINAR – ILC Dover: Handling Potent Products in a Sterile Environment
The need for flexible solutions for potent product handling is increasing. We’ll discuss the proven benefits of aseptic isolator systems in sterile environments and take a look at real feedback from real customers of ours in an upcoming webinar on Tuesday, November 16th at 11:00 AM EST.

Celanese Live Webinar: Engineering Drug Delivery to Improve Therapeutic Outcomes
Celanese and ThermoFisher Scientific have partnered together to present the value of the VitalDose® EVA drug delivery platform and manufacturing through Hot Melt Extrusion (HME) on September 9, 2021.
WHITE PAPERS

WHITEPAPER – Protecting Workers and the Environment: Facilities and Processes Key to Safely Making Highly Potent Drug Products
Handling HPAPI drug products requires skill, expertise and knowledge of safety considerations. This whitepaper examines the importance of US based drug product manufacturing and facility requirements to safely and efficiently manufacture solid oral dosage (SOD) HPAPI products….

WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….

WHITE PAPER – Nanoparticles in Drug Delivery & Photothermal Therapies
Download this white paper to learn more about the applications of silica and metal-based nanoparticles in drug delivery and photothermal therapy…..

WHITE PAPER – Making Sub-Visible Particles Visible: Innovative Analytical Techniques for Detection & Identification
The demand for complex, often life-saving drug substances such as monoclonal antibodies, interferons, and peptides is on the rise, creating a greater need for innovative delivery mechanisms to administer these new therapeutics. For a variety of reasons, sub-visible particles….

WHITE PAPER: Controlled Synthesis of Lipid Nanoparticles Using the Automated Nanoparticle System
Particle Works’ leading microfluidic technology offers a unique automated nanoparticle generation platform for the production of homogeneous, controllable, and reproducible LNPs….
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.