Pharmaceutical Technology Editors

Thermo Fisher Scientific’s new and enhanced Quick to Clinic solution may help biopharma companies reach Phase I/first-in-human trials and file for investigational new drug (IND) review in as little as 13 months from transfection, the company announced in a June 14, 2021 press release. With this solution, emerging biopharma companies working on early development can now leverage a lab-to-clinic drug development solution designed to accelerate the journey from DNA to drug product.

Quick to Clinic leverages Gibco Freedom ExpiCHO, which is a royalty-free, high-yield expression system that can scale seamlessly from an R&D environment. The solution also includes critical activities, such as cell line development, process fit, analytical development, and qualification, resulting in a robust process platform for biopharma companies developing mammalian recombinant proteins. This capability allows companies to scale quickly from discovery phase, leveraging toxicology and good manufacturing practice (GMP) material. In addition, documentation provided by the Quick to Clinic program will allow companies to file for IND in an expedited manner and get to Phase I clinical trials quicker.

Furthermore, Quick to Clinic leverages Thermo Fisher's global network of facilities and scientific experts, combined with its track record and more than 30 years of development and manufacturing experience, to help biopharma companies target an accelerated pathway to IND without taking on significant risks that would disrupt their goals. Biopharma companies will also be able to create a strong foundation for future scale-up success.

"Emerging biopharma companies now make up a majority of the biologics development pipeline. Meeting critical milestones is paramount to the continued support of these programs, making speed to clinic more important than ever," said Paul Jorjorian, vice-president and general manager, biologics, at Thermo Fisher Scientific, in the company press release. "With our Quick to Clinic solution, we provide biopharma companies with the supply assurance and foundational platform they need to see their therapy through to the clinic that mitigates risk, accelerates timelines, and navigates the complex and changing regulatory environment. Ultimately, this will help to expedite the development of important medicines for patients."

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Thermo Fisher Scientific has introduced its new Quick to Clinic solution, which is designed to accelerate biologic drug development from discovery to the IND phase in a shortened period.

Thermo Fisher Scientific’s Clinic Solution Aims to Accelerate Biologic Drug Development

CatSci’s new analytical sciences laboratory in Dagenham, UK, is now open and will focus on combining analytical and synthetic chemistry expertise with the latest high-end equipment to solve current and future complex problems in the pharmaceutical industry. The new facility, launched in June 2021, will further cement the company’s position in the United Kingdom, making it a center for excellence in pharmaceutical research and development, the company stated in a June 8, 2021 press release.

The new facility is fully equipped with state-of-the-art analytical equipment, through a collaboration with Shimadzu, and provides high-quality analytical data and critical interpretation. The facility is a key early milestone in CatSci’s £3 million (US$4.15 million) investment plan and will better equip the company to meet the demand for solving multi-disciplinary analytical problems, which are growing because of the progress of new modalities and asset classes, such as oligonucleotides and cannabinoids. At the same time, new or modified regulatory requirements, such as nitrosamine determinations and trace impurity analysis, require the development of highly specific and sensitive methods.

“The opening of our analytical laboratory at LondonEast in Dagenham, UK, is an exciting step on our journey towards becoming a fully integrated CMC [chemistry, manufacturing, and controls] company that accelerates medicine development to deliver best-in-class therapeutics to those in need. Solving complex challenges that our customers face is at the core of what we do, and this new facility, filled with Shimadzu’s cutting-edge equipment, sets a new exemplary standard for measurement science in the industry,” said Ross Burn, CEO, CatSci in the company press release.

“The opening of this new facility deepens the level of support we can offer,” added Nigel Richardson, director of Analytical Technology & New Modalities, CatSci, in the press release. “We will also be upgrading the site with capacity for GMP [good manufacturing practice] analytical development and testing, which will further increase our ability to provide innovative, tailored solutions from early development pre-clinical data packages to late development Phase III impurity fate studies.”

CatSci has opened its new Dagenham, UK-based laboratory, which is dedicated to analytical excellence.

CatSci’s New UK Laboratory Now Open and Poised to be Analytical Center of Excellence

The Cell and Gene Therapy Catapult (CGT Catapult) has revealed, in a June 29, 2021 press release, that it will establish offices and laboratories in Edinburgh, Scotland, with the aim of maximizing scientific and industrial collaboration in cell and gene therapies across the United Kingdom.

This expansion, which has been achieved through a collaboration with the University of Edinburgh, will provide additional, regionally-focused support to the cell and gene therapy sector so that product development, clinical trials, and adoption of the advanced therapies can be accelerated. CGT Catapult Edinburgh will be located at the Institute for Regeneration and Repair in the Edinburgh BioQuarter and will be led by Jacqueline Barry, chief clinical officer at CGT Catapult.

“We are excited to be expanding the CGT Catapult’s presence in Scotland through today’s agreement with the University of Edinburgh. Edinburgh has developed an excellent academic base and the Institute for Regeneration and Repair is projected to have the largest accumulation of stem cell scientists in Europe, with nearly 500 currently located there,” said Matthew Durdy, CEO, CGT Catapult, in the press release. “We look forward to building on this local expertise and growing the existing infrastructure to create a cluster for the cell and gene therapy industry in Scotland and the North of England. This will help bring these potentially life changing therapies to patients and help create economic opportunity in region.”

“This is excellent news for the University of Edinburgh. We have made considerable progress towards translation of cell and gene therapies into the clinic and the expansion of the Cell and Gene Therapy Catapult provides a great opportunity to boost these endeavours,” added Stuart Forbes, director, Institute for Regeneration and Repair, in the press release.

“We look forward to welcoming the Cell and Gene Therapy Catapult as members of the Edinburgh BioQuarter community. It is another feather in the cap for our expanding expertise in advanced therapies, one of the key health innovation pillars of our growing ecosystem,” commented Anna Stamp, interim program director, Edinburgh BioQuarter, in the press release. “BioQuarter, as a leading innovation location, is the perfect place for CGT Catapult Edinburgh to work with researchers and health innovation businesses to translate, test and nurture new ideas at scale, at pace and on time.”

The Cell and Gene Therapy Catapult will establish offices and laboratories in Edinburgh, Scotland.

CGT Catapult Announces Expansion into Scotland

Evonik, a German specialty chemicals company, has announced its latest offering, which is an innovative green technology that can enable the large-scale synthesis of APIs in water. The new offering was revealed in a June 29, 2021 press release.

The “Chemistry in Water” technology works by using surfactants that form microscopic spheres in water, called micelles. These micelles then take on the role of nanoreactors, which means that organic reactions can be performed in water rather than organic solvents.

As a result of the capability to replace organic solvents, this new technology has the potential to improve the environmental footprint of drug manufacturing. To achieve this novel approach, Evonik has collaborated with Bruce Lipshutz from the University of California, Santa Barbara.

“Improving the environmental footprint for the synthesis of [APIs] is critically important for the sustainability of drug manufacturing going forward,” said Stefan Randl, head of Research, Development, and Innovation for the Health Care business line of Evonik, in the press release. “It is a great pleasure to work with technology pioneer Professor Bruce Lipshutz and bring Chemistry in Water to commercial scale.”

“After many years developing aqueous micellar chemistry, it is immensely rewarding to see industry applying and further developing its potential,” added Lipshutz, in the press release. “I am confident that working closely with Evonik, as the first adopter for [contract development and manufacturing organization] purposes, will pave the way for wider applications to industrial projects and overall, more sustainable chemistry.”

Evonik has released an innovative green technology that can enable the large-scale synthesis of APIs in water. 

Evonik Offers Green Tech for Sustainable Pharmaceutical Production

Prior to the 2021 Pharmapack Europe event, which is scheduled to be held in Paris, France, Oct. 13–14, 2021, the event organizers have revealed that there have been increased levels of innovation in drug delivery across the industry, which is apparent with the number of regulatory approvals being achieved.

As reported in a June 25, 2021 press release, since the previous event, held in February 2020, European drug delivery innovation has risen across all the major European markets—Switzerland, Germany, United Kingdom, France, Italy, and Spain—as revealed by the Pharmapack Innovation Index, which is a reputation score carried out in the industry. The event organizers have announced that the 2021 Pharmapack Innovation Index will be published prior to the event in October, along with a detailed report covering the current and future trends in drug delivery and packaging.

“It has been more than a year since the last Pharmapack event was held, and we have seen tremendous innovation in the market during that time,” said Sherma Ellis Daal, brand manager at Pharmapack Europe, in the press release. “It’s one of reasons we are so excited to return as we can bring together the pharma packaging community and help foster partnerships so they can accelerate these innovations to patients. In particular we are looking forward to the return of the Pharmapack awards and the latest innovations exploring eco-friendly and patient-centric solutions released to market.”

Pharmapack Europe event organizers have revealed increased levels of innovation in drug delivery across the industry, substantiated by the level of regulatory approvals.

Pharmapack Innovation Index Reveals Continuing Innovation in Drug Delivery Across Europe

Sphere Fluidics, a provider of single cell analysis systems, and ClexBio, a provider of solutions for tissue engineering and single-cell techniques, now offer a biocompatible CYTRIX Microfluidic Hydrogel Kit, which they launched in June 2021.

The kit combines ClexBio’s novel CYTRIX Hydrogel with Sphere Fluidics’ specially designed Pico-Gen double aqueous biochip to allow the plug-and-play generation of defined, reproducible and tailorable hydrogel microstructures for three-dimensional (3D) cell culture, organoids, single-cell analysis, and other applications. These capabilities allow researchers to study valuable cells over many weeks rather than days in defined microenvironments that mimic the natural extracellular matrix, the companies stated in a June 7, 2021 press release.

The novel hydrogel overcomes the challenges of existing microfluidic hydrogel formation techniques, such as clogging, temperature control difficulties, or time-critical mixing procedures, and offers cytocompatibility and microfluidic-optimized gelation kinetics. These benefits provide researchers with a cell-friendly solution to reduce the effect of harmful temperatures, pH changes, and use of ultraviolet light required for existing hydrogel formation techniques. Paired with the Sphere Fluidics Pico-Gen double aqueous biochip and microfluidics, the CYTRIX Hydrogel enables efficient encapsulation of mammalian cells, bacteria, and other microorganisms in a homogeneous and defined extracellular matrix that supports cell viability.

“The CYTRIX Microfluidic Hydrogel Kit mimics the 3D microenvironment and helps researchers explore the potential of hydrogel-based microfluidics in tissue engineering, drug discovery and regenerative medicine over many weeks,” said Xin Li, associate director of Science at Sphere Fluidics, in the press release.

“This exciting collaboration with Sphere Fluidics has enabled us to deliver one of the first commercial solutions that allows simple and cell-friendly formation of cell-laden microgels, lengthening the time that researchers can study the contents of microspheres,” said Armend Håti, CEO and co-founder of ClexBio, in the press release.

The CYTRIX Microfluidic Hydrogel Kit is the first in Sphere Fluidics’ new range of 3D cell culture kits in partnership with ClexBio.