Feliza Mirasol is the science editor for 

Feliza Mirasol

On Sept. 20, 2023, Orionis Biosciences, a privately held US-based life sciences company with an integrated drug discovery and chemical biology platform, announced that it has entered into a multi-year collaboration with Genentech, a member of the Roche Group, under which the companies will discover novel small-molecule therapeutics for challenging disease targets, including oncology and neurodegeneration.

Under the agreement, Orionis will discover and optimize molecular glues using its Allo-Glue platform. The molecular glues will be used for Genentech’s designated targets. For its part, Genentech will take care of subsequent later-stage preclinical, clinical development, regulatory filing, and commercialization of such small molecules discovered through the collaboration. Orionis will get an upfront payment of $47 million and will also be eligible to receive development milestone payments, including commercial and net sales milestone payments, that may exceed $2 billion. The company can also receive a tiered royalty upon sale of collaboration products.

Orionis’s Allo-Glue platform works by using multiple unique approaches to discover drug-like small molecules against disease targets, particularly targets that have remained elusive to traditional discovery approaches. The platform is built on the integration of a suite of proprietary chemical biology technologies, including biological assays, computational analyses, chemical libraries, and automated processes. The platform allows for high throughput discovery, rational design, and optimization of small molecules that promote or induce interactions of proteins in living cells. Such molecules include molecular glues which have been shown to promote interactions that lead to either target degradation (via a ligase) or modulation of target function (via either direct or allosteric mechanisms), according to a company press release.

“Molecular glues represent one of the most exciting recent developments in small-molecule drug discovery. We are thrilled to collaborate with Genentech, a company long known for its world-class science and trailblazing medicines, to make use of technological innovations that we have systematically evolved over the past years to unlock novel target space with such drug modalities,” said Nikolai Kley, co-founder and CEO of Orionis Biosciences, in the press release. “We could not be more excited about the potential for this pioneering collaboration to lead to impactful new treatment paradigms.”

“Molecular glue degraders are an exciting modality to target disease-related proteins that have proven challenging with more traditional treatment modalities,” said James Sabry, global head, Roche Pharma Partnering, in the press release. “For patients with unmet needs, this offers a new therapeutic approach to modulate major disease drivers. This collaboration enables us to apply the concept of targeted protein degradation to discover and develop medicines for patients with serious and life-threatening diseases.”

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Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

Genentech Partners with Orionis Biosciences to Discover and Develop Molecular Glue Class Medicines

On Sept. 15, 2023, CPHI Barcelona announced the finalists for the 2023 CPHI Pharma Awards. The awards ceremony will be held on Oct. 24, 2023, the opening day of CPHI Barcelona, the world’s largest pharma event, at the Fiera Barcelona.

According to an event press release, the shortlist of finalists was narrowed down from more than 180 entries across 12 categories that cover innovations across the full pharmaceutical supply chain. The finalists featured include many of the pharma industry’s biggest names and breakthrough companies.

The 2023 awards mark the 20th anniversary of the CPHI Pharma Awards, which began in 2004. These awards have traditionally celebrated pharma’s brightest individuals and companies, and winners have been selected for their contributions to driving the industry forward through people, products, and performance. This year’s edition has introduced three new categories to reflect the wave of current innovation that has engulfed the industry, according to the press release.

The 2023 finalists include companies that led by example in sustainable manufacturing and manufacturers and innovators that developed new technologies to advance drug discovery, development, and manufacturing, as well as honoring transformational digital solutions of the future and philanthropic initiatives. The “CEO of the Year” category will celebrate this year’s most exemplary leader.

Each entry was extensively evaluated by an expert panel comprising individuals who collectively bring decades of expertise from big pharma, consultancy, regulatory, market intelligence, and academia.

The 2023 shortlist of finalists is as follows.

Aurorium: Detergent-free membrane protein solubilization agents

CurifyLabs Oy:The MiniLab: 3D printing personalized medicines service platform for pharmacies

 digital tools for reduction of clinical studies & product development timelines

KBI Biopharma: PUREcoli (part of PUREplatform solution)

Kepler Healthcare PVT Ltd.: Bi-folate syrup

Single Use Support: RoSS.PADL–homogenizing solution

SK pharmteco: “A modular platform for rapid and flexible Continuous Manufacturing of APIs under cGMP [current good manufacturing practice].”

Cromaoak: Multifrequency liquid chromatography

IOL Chemicals and Pharmaceuticals Limited: Sitagliptin phosphate monohydrate

Merck: ChetoSensar novel solubilization technology for hydrophobic antibody drug conjugates

Snapdragon Chemistry, a Cambrex company: Axial Chirality in the Sotorasib Drug Substance: Leveraging a High-Temperature Thermal Racemization to Recycle the Classical Resolution Waste Stream

Symbio Generrics India Pvt Ltd.: EcoPrimeAPI: Revolutionizing sustainability, scalability, and commercialization through green chemistry development in API.

Accord Healthcare Ltd.: Working Together to Make it Better; Driving Healthcare Equity

Eurolab (Pty) Ltd.: Eurolab (Pty) Ltd – Health Equity Initiatives

Zentiva: Supplying Ibuflam Suspension 40 mg/mL to the German market in crisis situation

Lambda Therapeutic Research Ltd.: Bindi Chudgar

Adalvo: Drug delivery & device Innovation for: fentanyl; dalbavancin RTU (ready to use); lisdexamfetamine oral solution; pregabalin; rosuvastatin/candesartan; ambrisentan/tadalafil

Amaterasu Lifesciences LLP: SiDMI–single dose anti-malaria injection

ApiJEct Systems: ApiJect prefilled injector

Lonza: Capsugel Enprotect enteric drug delivery

Medicsen: Sonophoresis Smartpatch for needle-free drug delivery

West Pharmaceutical Services: The FluroTec 5–10mL Cartridge Plunger, the 13mm NovaPure Ready to Use Stopper & the Flip-Off CCS Seal combined offering to support large volume injection.

Adalvo: Lisdexamfetamine oral solution, nitrofurantoin, dalbavancin RTU (ready to use); fentanyl; rosuvastatin/candesartan; ambrisentan/tadalafil; semaglutide

Halewood Laboratories PVT Ltd.: ORS with postbiotic with zinc

Kepler Healthcare Pvt Ltd.: Bi-folate syrup

Lubrizol Life Science Health: Apisolex Polymer

MedPharm: MedSpray Patch-in-Can Aerosol Technology

Nanoform: Nanoform’s nanoamorphous to nanocrystalline platform

ProBiotix Health Plc: CholBiome CH–cholesterol-reducing food supplement

Thermo Fisher Scientific: Development of an orally delivered large-molecule biologic for clinical trials

Zentiva: Daruph–dasatinib, company’s first value-added medicine, which is a lifesaving oncology treatment indicated to cure chronic myeloid leukemia and acute lymphoblastic leukemia.

Dr. Reddy's Laboratories Ltd.: Dr. Reddy’s digital journey to keep medicines affordable

FabRx: FabRx's M3DIMAKER pharmaceutical 3D printer series

Honeywell Process Solutions: Honeywell Manufacturing Excellence platform

Hovione: iSDX–a fully automated, scale representative laboratorial spray dryer

Nanoform: Globally unique high-potency nanoparticle GMP production site

Piramal Pharma Solutions: Throughput Improvement in peptide API manufacturing

SmartSkin Technologies: SmartSkin pressure and seal tightness drones.

Bilcare Limited: Elite PVC-free compact barrier coldform blister

IMA S.p.A.: Croma, continuous tablet coater

Körber Pharma Packaging Materials: Rapid test made out of cardboard

Rotor Print: Recyclable blister: PET 100%

Syntegon Technology GmbH: Versynta microBatch.

DDReg Pharma Pvt. Ltd.: Technology-enabled regulatory services through Vitalic

Eurolab (Pty) Ltd.: Eurolabs Exemplary Regulatory and Compliance Practices in Expanding Access to Affordable Oncology Products in Africa

Famar: Famar Integrated System of Flash Audits: Innovation in auditing

Lambda Therapeutic Research Ltd.: Enhancing Compliance & Data Generation in Clinical Trials through Advanced Software Solutions and EDC Platform

Loftware: Loftware Spectrum for Medical Device

Mitsubishi Chemical Group: The LSG (Life Science Grade) Portfolio—A thermoplastic stock shapes product portfolio for bioprocessing and medical applications.

Bionter: Bionter EVE the particle counter

Cellexus International Ltd.: The CellMaker

Congruence Medical Solutions, LLC: High Dose Autoinjector with Injection Pause

Dr. Ferrer Biopharma: GentleMist Technology

IamFluidics B.V.: Revolutionizing microencapsulation with in-air microfluidics technology for next-generation sustainable healthcare solutions

ACI Group: SCM software tool for pharma distribution

Catalent: Case management services for cell/gene therapies

Cipla: Digital innovation at cipla global supply chain

Thermo Fisher Scientific: mySupply Platform.

The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.

Pharma Award Finalists for CPHI Barcelona Have Been Announced

On Sept. 18, 2023, Sandoz announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion on the company’s biosimilar trastuzumab (150 mg, for intravenous use), a monoclonal antibody for treating human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, the same indications for which the reference biologic is approved in Europe. The biosimilar trastuzumab was developed by EirGenix, a Taiwan-based biopharmaceutical company.

Under an April 2019 licensing agreement (1), EirGenix will maintain responsibility for the development and manufacturing of the biosimilar trastuzumab, while Sandoz holds the rights to commercialize the product once approval is gained in respective markets.

Breast and gastric cancers have significant impact in Europe, with more than 355,000 women each year diagnosed with breast cancer. With 92,000 deaths per year, breast cancer is the number one cause of cancer death among women, according to a company press release. Gastric cancer, meanwhile, is the sixth most common cancer type and ranks the fourth most common cause of cancer-related deaths in Europe, with 107,000 deaths annually, according to the release. HER2 protein overexpression (or HER2 gene amplification) is detected in up to 20% of breast cancers and up to 30% of gastric cancers that are diagnosed. The overexpression of this protein leads to uncontrolled growth and division of cells, and HER2 cancers are known to be particularly aggressive cancer types that respond well to targeted treatment, according to the press release.

The regulatory submission package for Sandoz’ biosimilar trastuzumab comprised comprehensive analytical, preclinical, and clinical data and included evidence that was derived from extensive analytical characterization. Data also included results from a Phase I pharmacokinetic/pharmacodynamic study and a confirmatory Phase III study. The results showed that both studies met their respective primary endpoints, which confirms that the biosimilar matches the reference biologic in terms of both pharmacokinetics and efficacy, safety, and immunogenicity.

“Breast and gastric cancers are among the most frequently occurring in Europe and, combined, are responsible for nearly 200,000 deaths annually. Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines,” said Pierre Bourdage, chief commercial officer, Sandoz, in the release.

1. EirGenix, Eirgenix Signs Trastuzumab Biosimilar License Agreement with Novartis Sandoz. Press Release, April 30, 2019.

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

The opening of a new solutions center in Bengaluru, India, by Illumina, a US-based company specializing in DNA sequencing and array-based technologies, in August 2023 not only expands Illumina’s capabilities in genomics, but also expands access to genomics in that country.

The new center houses a fully equipped laboratory with the latest next-generation sequencing and array technologies. It is also fully resourced with field applications and service engineers that can offer broad genomics capabilities. The center will also provide training and education to increase technical expertise and access to genomics locally.

The new center is a permanent facility on the ground in Bengaluru for Illumina, which has spent the past 16 years working in partnership with Premas Life Sciences, an India-based contract research organization and provider of niche technologies in genomics, cell biology, and biopharma. With the help of the new solutions center, Illumina will continue collaborative work with Premas to grow the genomics market in India, according to an Aug. 17, 2023 company press release.

"Expanding Illumina's presence in India allows the company to collaborate and be part of a vibrant biotech ecosystem with skilled labor, strong research and development resources, and supportive government policies," said Gretchen Weightman, senior vice-president, Asia Pacific, Middle East & Africa, Illumina, in the company press release. "In our 25th anniversary year, it's a very exciting time to be growing our physical presence in India to drive access and the further adoption of genomics to transform human health, particularly in oncology and infectious disease."

Illumina’s business in India is led by Abhishek Gupta, country manager, and, according to Weightman in the press release, "Abhishek brings vast knowledge and experience to Illumina India, and we look forward to supporting him and the team as they collaborate with and support our customers." said Weightman.

The new solutions center also presents the opportunity to pursue equitable access and more diverse data in India. "Democratizing genomics and making it available to the many and not just the few will take a collaborative approach. We must better reflect diversity in genomic data and drive awareness for, access to, and adoption of genomic technologies, through partnership," Weightman said in the release.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Illumina Establishes New Center in India to Expand Genomics Capabilities

In today’s biologics/contract research organization (CRO) labs, more data than ever are being generated on protein characterization, thanks to advanced and more thorough analytical technologies. Managing these volumes of data, especially in the clinical phases of drug development, has become a real challenge for researchers.

Clinical trial data are at the heart of how biopharma companies develop new therapeutics for commercial launch, but developing a new drug and bringing it to market can take a decade or more and cost upwards of a billion dollars (1). Outsourcing clinical trial services has become a common practice to save a biopharma company on cost and time, but the practice brings up risks in data transfer as well as data management.

Laboratory issues can result in a delay of data receipt as well as poor quality of data, which can lead to rejection or rework. Data entry issues, delays in responses to data queries, errors during data transfer and merger, and discrepancies due to poor database setup can all also be the cause of delays (1).

A discussion with David Hardy, PhD, senior manager, Data Analytics and AI Enablement, Digital Science Solutions, Thermo Fisher Scientific, explores best practices for how to approach data management in today’s biopharmaceutical lab and highlights some effective strategies for distilling meaningful interpretation from these data.

 Although solutions such as laboratory information management systems (LIMS) and the electronic lab notebook (ELN) have helped to address the vast amounts of data being generated in biologics/CRO labs, what are the biggest challenges facing LIMS and ELN?

 The biggest challenge when it comes to LIMS and ELNs is ensuring that these systems fit seamlessly into laboratory processes to make sure they are used throughout an organization, at which point they can be better used to unlock deeper data-driven insights. Usability can also be a challenge of many LIMS and ELN solutions, but it is critical for company-wide, successful adoption.

Another important challenge is that, while LIMS and ELN can help ensure data quality after data capture, they can do little to rectify errors made through poor quality input data. To help improve data quality at the point of data generation, labs should seek to use automation wherever possible.

 Do automation and digitalization truly offer solutions that allow scientists to analyze these data in a meaningful way, or are there as much cons as there are pros to using such advanced technologies for the data scientist?

 The pros and cons of using automation and digitalization tools to analyze large amounts of data are the same across all applications, including biologics. For example, biologics labs still need to conduct initial validation of their tools and constantly check them, requiring close collaboration between the laboratory and data scientists. However, over time, the pros of advanced digitalization and automation tools—greater accuracy, reproducibility, efficiency, and deeper insight—vastly outweigh any initial cons.

Importantly, even with advanced technologies, scientists face the hurdle of understanding their data and which data fields to use. Then, they need to be clear on which model best suits the problem they’re trying to solve. This isn’t always easy but analytics solutions are striving to make this simpler.

 How has the user (i.e., the scientists) experience been affected or changed by the amount and quality of data being generated and the ability to manage that data?

 By their nature, scientists are data savvy. However, with the sheer amount of data that labs generate, as well as the need to manage these data with advanced technologies, scientists have had to become more tech savvy. For example, most scientists have the knowledge and skills to check and analyze their data using languages such as R, Python, and tools such as KNIME [Konstanz Information Miner]. Given the growing importance of these skills, they are now widely taught to undergraduate students.

Scientists have also embraced ‘big data,’ adopting new technologies to such an extent that big data isn’t the obstacle it once was. Given the increasing importance of technology in handling and processing such data, scientists now commonly work alongside their data science, IT [information technology], and TechOps [technical operations] colleagues to find the optimum and most cost-effective solution, which was less common in the past.

Beyond data capture, storage, and analysis, labs increasingly need to be able to use their data to their full potential. Accordingly, we’ve seen scientists increasingly focus on the FAIR (findable, accessible, interoperable, and reusable) data principles. Data [are] only truly useful if [they meet] these requirements.

 What would you say are some key best practice habits or techniques that scientists can employ to managing these data?

 Scientists can—and should—do several things to maximize their ability to manage these data. First, they should embrace automation, as it’s a scientist’s best friend. With more automation, scientists get free time to focus on more important, value-adding activities.

Scientists should also keep in mind that managing all of these data is a team sport. Data Science, IT, and TechOps teams are there to help, so scientists should leverage their expertise and support to maximize their chances of overcoming data challenges.

Finally, scientists should keep up to date on the latest technologies for managing and analyzing data—the field is advancing very rapidly, and taking your eye off the ball, even briefly, can lead to missed opportunities.

 What are some effective strategies that scientists can use to ensure that they are processing quality lab data and not just noise (are there such strategies)?

 As the saying goes, ‘garbage in, garbage out.’ That is to say that the root of good quality data is good input—good experiment design followed by good execution. Scientists can achieve these in several ways.

For example, they can adopt electronic tools such as laboratory execution systems (LES), which help by ensuring scientists follow methods and procedures correctly. LES and LIMS can also flag anomalous result values that fall outside a given specification range, helping to ensure data quality.

Scientists should also look to adopt artificial intelligence (AI) technologies, as they can greatly help in improving data quality. But this doesn’t have to be an overwhelming task. It can help to start with a small project and build from there. For example, a lab might start by using an AI-based approach to identify systematic errors, before gradually expanding its remit and functionality. It’s important to engage the data science team early and draw on their experience as you embark on this new and exciting journey.

1. Johnson, J.; Kanagali, V.; Prabu, D. Third Party Laboratory Data Management: Perspective with Respect to Clinical Data Management. 

 (1), 41–44. DOI: 10.4103/2229-3485.124573

Advanced analytical tools generate more data in today’s labs than ever before.

Dealing with Data: How to Keep It Manageable

On Aug. 28, 2023, US-based Cellares, an integrated development and manufacturing organization (IDMO), announced that Bristol Myers Squibb has joined its Technology Adoption Partnership (TAP) program, a program that offers cell therapy developers opportunity to adopt Cellares’ automated manufacturing technology platform, the Cell Shuttle. Under the agreement, Bristol Myers Squibb will submit a proof-of-concept transfer process for the manufacture of one of its chimeric antigen T cell (CAR-T) cell therapies using the Cell Shuttle.

According to a company press release, Bristol Myers Squibb will use the program to evaluate Cellares’ automated manufacturing process and produce comparability data to confirm that the Cell Shuttle is a viable, cost-efficient, and scalable manufacturing solution for cell therapies. Through its TAP program, Cellares is working with cell therapy developers to implement its manufacturing platform as a clinical and commercial-stage good manufacturing practice (GMP) manufacturing solution at its IDMO smart factories.

The company’s technology platform can support both autologous and allogeneic cell therapy processes as well as approximately 90% of cell therapy modalities. According to the company press release, manual processes can be automated and tech-transferred onto Cellares’ automated Cell Shuttle platform in six months’ time using the TAP program. Under TAP, participating cell therapy developers can tech-transfer their cell therapy processes onto a Cell Shuttle at any stage, such as during pre-clinical development, or in the clinic, or after regulatory approval. Automation, standardization, and software-defined manufacturing combine to make any follow-up tech transfer thereafter instantaneous to any other Cell Shuttle in any other IDMO smart factory in any global location, according to the press release.

“We’re pleased to welcome Bristol Myers Squibb to the TAP program, and we look forward to demonstrating the ease and efficacy of transferring one of [the company’s] cell therapy process[es] onto the Cell Shuttle in the months to come,” said Fabian Gerlinghaus, CEO, Cellares, in the press release. “By combining integrated automation with a high-throughput platform, the Cell Shuttle offers unrivaled scalability for the cell therapy industry, while improving quality and lowering COGS [cost of goods sold].”

The launch of the IDMO and smart factories

The partnership with Bristol Myers Squibb follows on the heels of Cellares’ initial launch as an IDMO, the first of its kind dedicated to clinical and industrial-scale cell therapy manufacturing, according to an Aug. 23, 2023 company press release. At the time of its launch, Cellares had raised $255 million in Series C funding, which was led by US-based investment firm Koch Disruptive Technologies and in which Bristol Myers Squibb participated, along with others.

With this funding, Cellares launched a commercial-scale IDMO smart factory in Bridgewater, NJ, the first of its kind, according to the company press release. The 118,000-ft2 smart factory is designed to integrate advanced robotics, purpose-built technology, and interconnected software and will be capable of producing 40,000 cell therapy batches per year. The Bridgewater site will be GMP-ready in the second half of 2024. Under the integrated technologies, IDMO smart factories can produce 10 times more cell therapy batches per year than traditional contract development and manufacturing facilities and with the same footprint and workforce, according to the release.

Cellares currently operates two smart factories in the United States and is planning a third. Its first smart factory, located in San Francisco, Calif., is currently being used for preclinical process development and for the tech transfer of manual processes onto the company’s Cell Shuttle platform for existing partners. The San Francisco facility will be GMP-ready in early 2024, according to the company press release. Cellares intends to deploy its smart factories around the world to serve global patient demand for cell therapies and will break ground on the first IDMO smart factory in Europe in 2024.

“The creation of the first IDMO marks the beginning of a new era, in which cell therapies will finally be able to reach those in need,” said Gerlinghaus in the press release. “We’ve developed integrated technologies for the entire drug development and manufacturing life cycle. Now we’re leveraging these technologies to offer global manufacturing services for the living drugs of the 21st century. Our partners are some of the best academics, biotechs, and large pharma companies in the world. We’re enabling them to meet total patient demand, improve consistency and quality, lower manufacturing costs, and accelerate expansion to new markets.”

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.