Behind the Headlines Episode 27

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

Artificial intelligence, machine learning, and novel instruments are helping drug developers.

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

J.P. Morgan Report Lists Biologics, Obesity, China

Top Trends Reshaping Pharma R&D

Colorcon, a company that participates in the development and supply of film coating systems, specialty excipients, and functional packaging for healthcare industries, announced on Sept. 5, 2023 the launch of a new Opadry film coating system to address the moisture management needs for pharmaceutical tablets without the use of titanium dioxide (TiO2), according to the press release.

“With uncertainty around the future of TiO2 use in pharmaceutical products marketed in the European Union, global pharmaceutical manufacturers are now formulating their products without the inclusion of TiO2,” said Annabel Bordmann, Film Coatings General Manager, in a press release. “Many pharmaceutical active ingredients are moisture sensitive and require a protective coating. This new Opadry formulation delivers the TiO2 free claim and provides functional moisture protection while upholding productivity levels and overall cost effectiveness.”

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.

“Moisture management is a critical aspect of pharmaceutical formulations and manufacturing, especially when it comes to tablets. Exposure of active pharmaceutical ingredients (APIs) in tablets to the environmental moisture, reduces product stability,” said Dr Ali Rajabi-Siahboomi, VP & Chief Innovation Officer, in a press release. “With Colorcon’s in-depth knowledge of materials, coating technology and regulatory needs, we have developed this new Opadry TiO2 free formulation that is specifically designed to deliver protection from environmental moisture on storage and during use by patients. The coating is easy to apply and efficient for manufacturers”.

Articles

Colorcon Launches New Titanium Dioxide Free Moisture Protection Coating for Pharmaceutical Tablets

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Makers of parenteral products gained a new vial option with this summer’s launch of Viridian Vials by Corning. The vials serve as a drop-in replacement on fill/finish lines and combine performance and improved safety with sustainability (1), often a challenging objective for pharmaceutical manufacturers since packaging for parenteral products is likely to be incinerated and landfilled (2).

The improved sustainability profile can be attributed to a 20% reduction in glass material versus conventional glass vials, with no impact on the quality or safety of the vial. This reduction in glass material lowers manufacturing and transportation-related emissions (carbon dioxide equivalents) by up to 30% and decreases the total amount of glass entering the waste stream and ending up in the landfill (1). In addition, vials are produced using 100% renewable electricity (2).

Under development for several years, the Viridian Vial features a nanometers-thick coating, which reduces the coefficient of friction on the outer surface of the vial. It also reduces glass particulates in the fill/finish process by up to 96% (3). The proprietary polymer coating, which was developed for the company’s Valor Glass vial, introduced in 2017, ensures a low coefficient of friction before, during, and after filling to protect the vial and its contents (2). Viridian Vial’s external coating is capable of withstanding temperatures up to 360 °C and can maintain the vial’s strength during transportation, fill/finish, and delivery, helping to minimize cracks, breaks, and cosmetic rejects while substantially reducing tipovers and improving filling-line efficiency by up to 50% (1, 3). This increase in efficiency also has the potential to lower total product costs (3).

Extensive testing of the coated vial has shown the coating is robust under typical fill/finish conditions including machine-to-vial and vial-to-vial contact as well as when experiencing temperature extremes from the heat of depyrogenation to the cold of cold storage and lyophilization (4). “The tests indicate the coating remains where it is supposed to be, on the outside of the vial,” says Ron Verkleeren, senior vice president and general manager, Corning Life Sciences.

Commercial applications await FDA approval, but Verkleeren expects the approval process to move smoothly because the vials are made of Type I glass, an industry standard, and regulatory approval has been given to drugs packaged in Corning’s Valor Glass vials and Velocity Vials, which use the same external coating as Viridian Vials. “All elements of the process have been approved in one form or another,” he notes. “As a result, the regulatory approval process should be exactly the same if a customer is using Viridian Vials or a conventional Type I vial.”

The first product to use the vial could be almost any drug that is compatible with Type I glass, from a pediatric vaccine to a generic small-molecule formula. However, Verkleeren thinks a small-molecule drug is the most likely product to be first on the market in the Viridian Vial. “The validation process tends to be more straightforward for small-molecule drugs,” he explains. 

West Pharmaceutical Services serves as the exclusive distributor for Viridian Vials (1).

1. Corning. Corning’s New Viridian Vials Reduce Waste and Carbon Emissions in the Pharmaceutical Supply Chain. 

2. Forcinio, H. Phone interview with Ron Verkleeren, senior vice president and general manager, Corning Life Sciences. July 12, 2023.

3. Corning. Corning Viridian Vials. Brochure, 2023.

Corning launches a more sustainable glass vial. 

Vial Options Expand

Otsuka Pharmaceutical and ShapeTX announced on Sept.7, 2023 a multi-target collaboration to develop intravitreally delivered adeno-associated viruses (AAVs) for ocular diseases, with the possiblity to add additional targets and tissue types. According to the press release, the companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

The AAVid platform combines throughput screening of billions of unique AAV variants and machine learning to identify novel AAV capsids for direct-to-NHP 

 selection to maximize clinical translation. Further, according to the release, AAVid capsids are designed for precise target tropism while detuning for off-target biodistribution, which reduces the required dose and associated clinical safety risks. In addition, ShapeTXTX will apply the company’s transgene engineering technology to optimize payloads provided by Otsuka for therapeutic levels of gene expression in targeted cell types.

Under the new agreement, ShapeTXTX will receive an initial payment from Otsuka and is eligible to receive development, regulatory, and sales milestone payments that will potentially exceed $1.5 billion in aggregate value. ShapeTXTX is also eligible to receive tiered royalties on future sales of products resulting from the collaboration, according to the press release.

“We’ve built our AAVid platform on generative AI approaches akin to those behind Midjourney and DALL-E 2 to tackle industry challenges with gene therapy delivery,” said Francois Vigneault, PhD, co-founder and chief executive officer of ShapeTXTX, in a press release. “By incorporating diffusion models, our platform is designing novel medicines that transcend the boundaries of what is possible experimentally. Our collaboration with Otsuka marks an exciting chapter in our journey as we extend the reach and impact of our technologies to help as many patients as possible.”

The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

Otsuka Collaborates with ShapeTX for Development of AAV Gene Therapies

Recipharm is partnering with Ahead Therapeutics, a Spanish start-up biotech company, to develop a ground-breaking treatment for a rare autoimmune disease, known as myasthenia gravis, using proprietary technology to develop treatments for different autoimmune disorders.

Ahead Therapeutics is known for the development of an innovative solution based on the use of PS-liposomes containing autoantigens, according to the press release. These liposomes can induce antigen-specific immune tolerance through a biomimetic process, thereby interrupting the autoimmune reaction. Further, the company’s newly developed solution for myasthenia gravis, which is intended for parenteral administration, is based on the use of phospholipid liposomes containing the antigen peptide. Through a biomimetic process, these liposomes can induce antigen-specific immune tolerance, which then interrupt the autoimmune reaction.

According to the press release, Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide. Further, Recipharm also offers the capacity to scale up manufacturing and preparation for commercializing the therapy.

Myasthenia gravis is defined as a rare, autoimmune disease that most commonly affects the muscles controlling the eyes and eyelids, facial expressions, chewing, swallowing, and speaking. There are currently no cures, and treatments and chronic and symptomatic.

“Autoimmune diseases affect approximately one in ten individuals, meaning 0.8 billion patients globally will be able to benefit from the drugs derived from our platform. Recipharm is dedicated to helping organisations like ours that work to develop treatments for rare diseases,” said Dr. Martí Dalmases Arnella, CEO of Ahead Therapeutics, in a press release. “This agreement represents a key milestone and the beginning of an exciting journey. Recipharm is the pharmaceutical industry’s best-in-class provider of contract development and manufacturing solutions, and we are looking forward to working closely with the team on this project.”

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide. 

Recipharm Partners with Ahead Therapeutics to Develop Rare Autoimmune Disease Therapy 

Rentschler Biopharma, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced on Sept. 13, 2023 that it has received the cGMP Manufacturing Compliance Certificate following a successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at the UK site. According to the press release, the ATMP business was announced in early 2021 and the facility is in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage, UK.

“MHRA’s approval marks a major milestone for Rentschler Biopharma, and we are excited to offer our services from process and analytical development through cGMP manufacturing. Our team is highly knowledgeable, bringing years of experience in the field of AAV,” said Dr. Robert Panting, general manager of Rentschler’s ATMP business, in a press release. “We provide a tailored program for each client, in line with their needs and stage of development, while working closely with them to move projects forward as rapidly as possible. We are thus continuing the Rentschler tradition of offering a truly client-centric approach with the ultimate goal of helping patients. With our first clients already on board, we look forward to adding other exciting programs soon.”

According to the press release, following the MHRA inspection, Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

“Our contribution to improving the health and quality of life of seriously ill patients, is made possible by continuously expanding our expertise in the production of essential biopharmaceuticals. By launching Rentschler’s ATMP business, we aim to address an important gap in expertise and support for innovative, early-stage cell and gene therapy programs,” said Dr. Christian Schetter, chief scientific officer of Rentschler Biopharma, in a press release. “It is gratifying to achieve this important milestone of MHRA approval, bringing us closer to reaching our objective of supporting clients already from the earliest stages of CMC development. We are continually looking to understand not only current client needs but future ones as well, which is how our ATMP offering came to fruition. We will continue to listen to our clients to anticipate how we can improve our offering and collaborate in advancing medicine to save lives, together.”

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

Rentschler Biopharma ATMP Facility Receives MHRA Approval

Nurix Therapeutics announced on Sept. 7, 2023 that it has entered a multi-year, multi-target strategic collaboration agreement with Seagen, to further advance a new class of medicines, called degrader-antibody conjugates (DAC), for use in cancer treatment. According to the press release, the collaboration between the two companies will focus on an innovative approach to combine two powerful technologies to target cancer, antibody-drug conjugation (ADC) and targeted protein degradation (TPD), with the intention of creating drugs with new mechanisms of action, improved specificity, and anti-cancer activity.

“By combining the tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins, we believe that DACs may represent a next generation of cancer medicine for a wide range of solid tumors and hematologic malignancies,” said Arthur T. Sands, MD, PhD, president and chief executive officer of Nurix, in a press release. “With Seagen, our strategic goal is to advance ADC technology to the next level to provide patients with new DAC drugs that deliver greater anti-tumor efficacy and safety compared to currently available agents.”

According to the agreement terms, Nurix will receive an upfront payment of $60 million and the potential to receive up to approximately $3.4 billion in research, development, regulatory, and commercial milestone payments across multiple programs. Further, as a part of the multi-year collaboration, Nurix will use its proprietary DELigase platform to develop a suite of targeted protein degraders against multiple targets nominated by Seagen that are fitting for antibody conjugation. According to the press release, Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

“The targeted protein degrader modality provides unique advantages over payloads currently employed across the ADC field,” said Gwenn M. Hansen, PhD, chief scientific officer of Nurix, in a press release. “This collaboration is a new application of our DELigase technology, and we are delighted to work with Seagen, a pioneer in the development and commercialization of ADC therapeutics, to create a new generation of drugs to fight cancer.”

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

Nurix Announces Strategic Collaboration with Seagen

On Sept. 6, 2023, Charles River Laboratories International and PathoQuest announced the publication of the results of a seminal study in 

, which demonstrated the proprietary, good manufacturing practice (GMP) grade, next-generation sequencing (NGS)-based assay from PathoQuest had a greater capability of detecting viral contaminants when compared to 

The objective of the study was to compare classical 

 testing methods used to screen cell lines for adventitious viruses with a GMP-compliant viral transcriptome NGS assay. Further, the study was conducted as a head-to-head comparison of standard 

testing and NGS-based testing of cell substrates.

According to the press release, the team of Charles River experts prepared test materials and ran the 

 assays, while PathoQuest’s team tested the material with their proprietary NGS-based assay. There were cells infected with a wide variety of viruses reflective of the diversity and various patterns of virus-cell interactions in a real-world setting for biologics to determine the range of detection. Additionally, the infected cells were increasingly mixed with uninfected cells to further assess the analytical sensitivity and analyzed across several conventional 

 tests and with the NGS-based transcriptomic assay.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to 

 adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

“Our study demonstrates that PathoQuest’s unique NGS assay significantly increases the capability of detecting viral contaminations in cell substrates like cell banks, the starting material for biologics production, and in bioreactors during biologics production. The test has been validated to GMP standards and provides the pharmaceutical industry a faster, more efficient, and reliable testing option compared to animal-based testing,” said Professor Marc Eloit, DVM, PhD, head of the Pathogen Discovery Laboratory at the Institute Pasteur and Founder of PathoQuest, in a press release.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Charles River and PathoQuest Publish Study Validating Proprietary Next-Generation Sequencing Viral Safety Assay 

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

In a European Medicines Agency (EMA) press release on September 9, 2023, the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) outlined new measures to avoid fetus exposure to topiramate-containing medicines. Topiramate is known to cause serious birth defects if used during pregnancy, and medicines containing it may increase the risk of neurodevelopmental problems in children. In the European Union, topiramate-containing medicines are used to treat epilepsy and prevent migraines; in some EU countries they are also used with phentermine for weight loss.

As of the publication of this article, PRAC recommends that unless there is no other treatment available, patients using topiramate to treat epilepsy should not use the medication while pregnant. Topiramate must not be used to prevent migraines or manage body weight while pregnant, and patients who are able to become pregnant must use birth control while taking topiramate. PRAC also recommends a pregnancy prevention program to inform those able to become pregnant of the risks associated with topiramate exposure in the womb.

Regardless of indication, topiramate should only be used by patients who can become pregnant when the following conditions are met:

the patient must take a pregnancy test before starting treatment

they must receive counseling on the risks of topiramate treatment during pregnancy

they must complete an annual risk awareness form during treatment.

These recommendations follow PRAC’s review of three recent observational studies, two of which suggest that children exposed to topiramate in the womb have a two- to three-fold higher risk of neurodevelopmental disorders. PRAC consulted with a group of experts, patient representatives, and specialists during the review. Companies marketing topiramate must conduct a drug utilization study, as well as surveys of healthcare professionals and patients, to evaluate the success of the new measures.

The product information for topiramate-containing medicines will be updated, and a visible warning will be added to the packaging of the medicine. Patients and healthcare professionals will also be provided with information on the risks of using the medication during pregnancy, and patients will be given a patient card with each package of the medicine.

A direct healthcare professional communication will be sent to healthcare professionals prescribing, dispensing, or administering the medicine. It will also be published on EMA’s website.

Topiramate can cause serious birth defects if exposed to children in the womb. 

PRAC Recommends New Measures to Avoid Topiramate Exposure in Pregnancy

Orano Med and Orbit Discovery announced on Sept. 11, 2023 that they have entered a collaboration to discover specific peptide receptor radionuclide therapies against cancer cells and advance the development of novel radiopharmaceuticals. According to the press release, the agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

“We’re delighted to continue expanding our existing portfolio of partners by collaborating with Orano Med who have a strong track record of discovering novel radiopharmaceuticals,” Neil Butt, chief executive officer, Orbit Discovery, said in a press release. “We’re very proud of our proprietary screening platform at Orbit and acknowledge its role in empowering the next wave of peptide therapeutics.”

Radioligand therapies rely on the concept of combining the ability of biological molecules, like peptides, to target cancer cells with the short-range cell-killing capabilities of radioisotopes. According to the release, the approach results in an increased cytotoxic potential toward cancer cells while still limiting toxicity to nearby healthy cells.

This collaboration will strengthen the capabilities of Orbit’s peptide display engine to identify peptide candidates specific to tumor-associated targets, and the technology enables the screening of large peptide collections through the combination of DNA encoded libraries and bead-based presentation, according to the press release.

“Since the inception of Orano Med, we have recognized the value of collaboration,” said Julien Dodet, chief executive officer, Orano Med, in a press release. “In our strategy to develop and deliver 212Pb Targeted Alpha Therapy for cancer patients, we’re delighted to work with Orbit Discovery and leverage its technology and expertise in peptide ligand discovery to build our pipeline of radiotherapies.”

The agreement states that Orbit will implement its bead-based peptide display engine to discover peptide leads specific to targets related to specific tumors.

Orano Med and Orbit Discovery Enter Collaboration for New Novel Targeted Radioligand Therapies 

FDA announced on Aug 30, 2023, that it is creating two compliance policy guidances initiating a year-long stabilization period for those in the pharmaceutical supply chain that need time to adhere to Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level. The policy effects trading partners, mainly manufacturers, wholesale distributors, dispensers, and repackagers. The requirements are scheduled to change on November 27, 2023, and the stabilization period lasts until November 27, 2024.

The DSCSA went into effect in 2013, and outlines the requirements for the electronic tracing and identification of prescription drug distribution in the U.S. It requires trading partners to supply, accept, and maintain documentation on prescription drugs and their chain of ownership in the U.S. supply chain, from manufacturer to dispenser. The current DSCSA requirements as of September 1, 2023, will be changed on November 27, 2023. The new requirements will include mandating that trading partners manage documentation of product and ownership electronically (previously, partners were permitted to do so in paper format).

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product —Compliance Policies

 Revision 1 (WDVRS). WDVRS Revision 1 adds a year extension (from November 27, 2023, to November 27, 2024) to a guidance released on October of 2020 that directs distributors to verify product identifiers before distribution. EDDSR covers FDA’s new compliance policies for product tracing at the interoperable, electronic, package level; these policies will go into effect on November 27, 2023.

FDA intends for trading partners to use the stabilization period to “build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients.” It is not intended as a justification for delaying compliance efforts with the DSCSA.

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

Featured Content

Behind the Headlines Episode 27

Ask the Expert

Drug Digest September 2025

Enhancing Bioanalysis and Drug Development with Advanced Tools and Technologies

Top Trends Reshaping Pharma R&D