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2017 GLOBAL DRUG DELIVERY & FORMULATION REPORT - Notable Technologies, Approvals, Transactions, Pipelines & Perspectives
This third annual report, a collaborative effort between team members at Drug Development & Delivery and PharmaCircle, provides a look back at 2016 in terms of approvals and developments in the area of drug delivery and formulation. The report continues to cover the following significant key points of interest, with the belief that understanding the past, even the recent past, can provide insights to what is possible.



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Contributor Cindy H. Dubin reports on a segment of the drug delivery industry that will see its market revenue double in just 5 years in response to a growing need to deliver highly viscous, high-volume drugs.
Torsten Maschke, CEO of Datwyler Sealing Solutions, speaks about the opportunities and challenges the current healthcare industry poses and how they are met by Datwyler’s strategy and products.
Jeannie Joughin, PhD, asks what does a pharmaceutical company do when everyone wants more effective new therapies but no one – including third-party payers – wants to pay the price for their development? De-risk the drug development process, in every possible way.
Detlev Haack, PhD, and Martin Koeberle, PhD, says an industry-wide focus on the design of packaging that can protect user-friendly dosage forms, as well as improve patient compliance and fit into modern consumers’ lifestyles, has resulted in a wide range of primary and secondary packaging solutions.
Tim Leaver explains how his company has developed a proprietary technology for the rapid development of nanoparticles and seamless scale-up for clinical studies and commercial production, and how it is transforming the development and manufacturing of a range of nanoparticle formulations from a hit-and-miss affair to a standardized process, accelerating novel nanomedicines from the bench to the clinic.
Contributor Cindy H. Dubin recently spoke with some of the leading excipient innovators to find out what types of excipients they are developing, the advantages they offer to formulations, and where they see the industry focusing throughout the next few years.
Aaron Goodwin, PhD, Alyssa Ekdahl, and Deanna Mudie, PhD, demonstrate the tunability of SDD particle properties and the resulting impact on the powder flow and mechanical properties for tablet manufacturability of a given SDD formulation.
Mike Schaefers, PhD, and Mike Treadaway say more than ever, contract manufacturing must deliver continuous innovation and flexibility to accommodate the delivery of a wide range of drugs throughout each therapy’s lifecycle.
John W. Burke, MS, says that success in lyophilization transfer and scale-up projects depends on a structured approach to information sharing between a pharma company and its CDMO partner, and should include extensive details about the APIs or bulk drug substance characteristics and planned development and clinical programs.
David A. Lewis, PhD, presents experimental data that shows how certain modifications to the Pharmacopoeial test methods used for MDIs may result in data that is more indicative of real-life performance, providing insight that can be used to enhance drug delivery characteristics.
Peter Stevenson, Vice President and General Manager of Pfizer CentreOne, discusses the value and significance of the embedded-CMO model in the biopharmaceutical industry.
Nick Grasman and Paula Garcia Todd, MS, present ETHOCEL HP as an innovative new product that helps customers increase productivity while still maintaining the advantages of Dow manufactured ETHOCEL, such as tight viscosity, narrow ethoxyl distribution, and reduced fiber content.
Exclusive Online Content
Roivant Sciences Launches Datavant to Improve Clinical Trials With Artificial IntelligenceRoivant Sciences Launches Datavant to Improve Clinical Trials With Artificial Intelligence
Roivant Sciences recently announced the launch of Datavant, a new company focused on employing artificial intelligence to improve the clinical trial process.

Catalent to Acquire Cook Pharmica for $950 MillionCatalent to Acquire Cook Pharmica for $950 Million
Catalent, Inc., the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products, recently announced it has reached an agreement to acquire Bloomington, Indiana-based Cook Pharmica LLC, an integrated provider of drug substance and drug product manufacturing and related services.

DFB Pharmaceuticals Forms NanOlogy & Soria for Clinical Development of Naked Nanoparticle Platform DFB Pharmaceuticals Forms NanOlogy & Soria for Clinical Development of Naked Nanoparticle Platform
DFB Pharmaceuticals, a privately held investment and development group in Ft. Worth, TX, has taken on this challenge by forming NanOlogy, in collaboration with CritiTech and US Biotest, to finance and develop a breakthrough technology platform for producing unique, patented, naked nanoparticles of paclitaxel and docetaxel.

APAC Drug Delivery Devices Market to Reach $5.4 Billion in 2023​APAC Drug Delivery Devices Market to Reach $5.4 Billion in 2023​
Drug delivery devices market in Asia Pacific (India, China, Japan, South Korea, Australia, New Zealand, and Taiwan) region is expected to grow at CAGR 3.9%, from $4.1 billion in 2016 to $5.4 billion in 2023, according GlobalData, a recognized leader in providing business information and analytics.

CordenPharma Inaugurates Third Development Suite for Highly Potent Oral Solid DosageCordenPharma Inaugurates Third Development Suite for Highly Potent Oral Solid Dosage
CordenPharma is pleased to announce the completion of its newest early development suite for Highly Potent, oral solid dosage products in CordenPharma Plankstadt (DE). The new facility allows for the production of small batches, from 100g to approximately 1000g.

AMRI Expands Sterile Production Capacity AMRI Expands Sterile Production Capacity
AMRI, a global contract research, development and manufacturing organization, is expanding its sterile manufacturing capacity. The addition of an aseptic pre-filled syringe filling line at our manufacturing facility in Albuquerque, N.M., adds capacity to manufacture roughly 50 million syringes per year.

GSK Exercises Option Over Adaptimmune’s SPEAR T-Cell Therapy Program GSK Exercises Option Over Adaptimmune’s SPEAR T-Cell Therapy Program
Adaptimmune Therapeutics plc, a leader in T-cell therapy to treat cancer, recently announced that GlaxoSmithKline plc has exercised its option under a collaboration and license agreement signed in 2014 to exclusively license the right to research, develop, and commercialize Adaptimmune’s NY-ESO SPEAR T-cell therapy program.

Novartis AG Receives First Ever FDA Approval for CAR-TNovartis AG Receives First Ever FDA Approval for CAR-T
A new era in cancer treatment is now here. The US FDA recently gave the nod to Switzerland-based Novartis AG for its gene therapy cancer treatment, a first in the US.

Huber Closes $630-Million Sale of Silica Business to EvonikHuber Closes $630-Million Sale of Silica Business to Evonik
The J.M. Huber Corporation has completed the sale of the Silica business unit of Huber Engineered Materials (HEM) to Evonik Industries AG, a global specialty chemicals company. The $630-million transaction, completed after approvals from the European Commission and other global regulatory bodies, transfers ownership of the HEM Silica facilities in North America, Europe and Asia to Evonik.

Roquette Completes Acquisition, Reinforces Ambition of Being Excipient Leader Roquette Completes Acquisition, Reinforces Ambition of Being Excipient Leader
Roquette, a global leader in innovative plant-based ingredients, recently announced it has completed the acquisition of Itacel from Blanver.
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