Feliza Mirasol is the science editor for 

Feliza Mirasol

Alpha Teknova, a US-based producer of critical reagents, and Sartorius BIA Separations, a part of Sartorius, announced a collaboration on March 15, 2023 under which the two companies will aid gene therapy companies to streamline the downstream purification process, specifically for the recovery of adeno-associated virus (AAV) capsids.

Under the collaboration, Sartorius BIA Separations will combine its proprietary AAV platform, which is designed to optimize the separation of viral particles, with Teknova’s custom, high-quality buffer solutions, which have been developed to maximize capsid enrichment. The companies have conducted a robust design of experiment and have successfully created a screening kit with optimized buffer formulations, according to a company press release. The optimized buffer formulations drive consistency and increased purity when they are paired with Sartorius BIA Separations’ AAV platform (BIA CIMmultus QA monolith).

Through the collaboration, gene therapy companies focusing on AAV will get access to all required consumables as well as a protocol that will streamline and accelerate the downstream processing workflow. According to the company press release, this advantage will enable these gene therapy companies to discover novel breakthroughs faster. Teknova and Sartorius BIA Separations intend to continue developing data that demonstrate the improvements in AAV purification that result from their combined methods.

“Through our collaboration, we’re finding new tools to help our customers streamline the development of AAV therapies by optimizing their purification process and increasing the yield and purity of their AAV product,” said Stephen Gunstream, Teknova’s president and CEO, in the release.

“Teknova is the perfect partner for us as we explore robust, end-to-end solutions for our gene therapy customers seeking to achieve better results in the separation and analysis of viral particles,” said Aleš Štrancar, managing director at Sartorius BIA Separations, in the release. “Based on their ability to quickly manufacture high-quality, custom buffers that are consistent from batch to batch, we’ve been able to reliably reproduce results and confidently target the discreet differences in empty and full AAV particles.”

Articles

Sartorius BIA Separations and Teknova will collaborate to combine their technologies in an effort to streamline the downstream purification process.

Sartorius and Teknova Team Up for Gene Therapy Process Development

Samsung Biologics announced on March 17, 2023 that it will begin construction of a fifth plant (Plant 5) near its current Songdo International Business District site in Incheon, South Korea, that will hold a capacity of 180,000 L. The company will invest more than ₩1.9 trillion (US$1.5 billion) in the new facility as part of its strategic capacity expansion, which is in response to increased market demand.

The company expects to break ground in the first half of 2023 and aims to start up operations in 2025. Plant 5 will be the first facility of the company’s second campus (Bio Campus II), which encompasses 96,000 m2, and, upon full completion, Samsung Biologics will hold a total of 784,000 L of manufacturing capacity.

The new plant is expected to further maximize operational efficiency and introduce advanced digitalization and sustainability features, according to a company press release. Samsung Biologics, which purchased 360,000 m2 of land in July 2022 for Bio Campus II, expects to house additional large-scale plants and an open innovation center on the campus. Overall, the company plans to invest ₩7.5 trillion (US$5.7 billion) in Bio Campus II.

The existing Plants 1 through 3 are at near-full utilization, while Plant 4, which started partial operations in October 2022, is expected to ramp up to full operations by mid-year 2023, according to the press release.

“Given the continuing increase in the demand for outsourced manufacturing of biopharmaceuticals, we are proactively making this investment in alignment with our growth strategy to further strengthen our standing as a leading CDMO [contract development and manufacturing organization],” said John Rim, president and CEO of Samsung Biologics, in the release. “The new facility will enable us to provide our customers with even greater innovation and services that will increase speed to market and flexibility.”

Samsung Biologics plans to invest more than ₩1.9 trillion (US$1.5 billion) in the new Incheon, South Korea, facility, which will hold a manufacturing capacity of 180,000 L.

Samsung Biologics to Build Plant 5 as Part of Capacity Expansion to Bio Campus II

Sandoz, the generics and biosimilars division of Novartis, announced on March 9, 2023 that it has signed a memorandum of understanding to build a new biologics production plant in Lendava, Slovenia. The company expects to invest at least $400 million in this project, which represents one of the largest international private-sector investments in Slovenia, according to a company press release.

Work on the new plant is set to begin in 2023, and full operations are provisionally planned for late 2026. The facility will support the increasing global demand for biosimilars.

“Biosimilar medicines increase access to cutting-edge biologic therapies for the patients who need them most. This investment underscores our ambition to be the sustainable global leader in biosimilars, a segment projected to grow double-digit annually over the next decade,” said Richard Saynor, CEO, Sandoz, in the press release.

“This state-of-the-art site will … enable[e] us to meet growing demand for our current and future biosimilars in the mid- to long-term. The location offers us a strong combination of political stability, proximity to our existing European-based production and commercial operations, and competitive costs,” said Glenn Gerecke, global head of Technical Operations, Sandoz, in the release.

In addition to this biologics production facility, Sandoz also 

recently announced in 2022 an additional €50 million (US$53 million) investment

 (1) to expand its European-based antibiotics production network. Altogether, the company’s total new investment commitment in the past few years to expand its European-based antibiotics production network comes to €250 million (US$266 million).

1. Sandoz, “Sandoz Announces Further Investment in Key Manufacturing Facility in Austria, to Support Increased Global Demand for Essential Antibiotics,” Press Release, Nov. 7, 2022.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Sandoz to Build New Biologics Production Facility in Slovenia

On March 16, 2023, Catalent announced that it has signed a licensing agreement with India-based Bhami Research Laboratory (BRL) that will provide Catalent with access to BRL’s formulation technology. Using the technology, Catalent intends to develop formulations that will help enable the subcutaneous delivery of high-concentration biologics. Financial terms of the agreement were not disclosed.

The agreement authorizes Catalent to collaborate with its customers to evaluate BRL’s formulation technology so that Catalent and its customers can explore ways to reduce viscosity and deliver high-concentration biologic products. BRL’s technology is applicable to a wide range of monoclonal antibodies and fusion proteins. Successful programs could be integrated into Catalent’s formulation and manufacturing services at scale.

According to a Catalent press release, the subcutaneous delivery of small volume, low viscosity biotherapeutics can provide superior patient benefits over traditional intravenous injections. Such benefits include improved access to healthcare, reduced need for hospitalization and overall treatment cost, and the opportunity to employ new delivery technologies, such as auto-injectors.

“The patented, high-concentration, low-viscosity protein drug delivery platform has been designed to make patient care convenient, affordable, and safe,” said Bhami Shenoy, co-founder and chief scientific officer of BRL, in the press release.

“This agreement allows Catalent Biologics to offer its customers a novel patented formulation that may be evaluated for enabling the delivery of high-concentration therapies by reducing viscosity,” said Julien Meissonnier, Catalent’s chief scientific officer, in the release. “The potential for maintaining the stability of a drug with the convenience of a pre-filled syringe or auto-injector could have a significant impact on reducing the barriers to subcutaneous delivery of therapies and improving the patient experience.”

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.

Catalent Licenses Bhami Research Laboratory Technology for Biologics Formulation Development

Genuv, a South Korean-based clinical-stage biotechnology company, announced on March 15, 2023 that it has entered into a partnership with South Korea-based biopharmaceutical company Celltrion to jointly discover and develop novel therapeutic antibodies. Under the agreement, the companies will use Genuv's proprietary SHINE MOUSE platform.

According to the agreement, Genuv will conduct antibody discovery services using its mouse platform technology. Drug discovery will be followed by a research collaboration. Celltrion has the option for joint research and development projects that, if exercised, will trigger agreed-upon milestones, which include development milestones of up to $25 million followed by total commercial milestones of up to $680 million. The latter amount will be triggered dependent upon the accumulation of $7.5 billion in sales per candidate antibody.

The advantage that the SHINE MOUSE platform offers rests in the platform’s ability to generate a greater diversity of antibodies than conventional mice can generate. This ability led to the discovery of the experimental, novel anti-programmed cell death protein 1 monoclonal antibody, GNUV201. GNUV201 holds unique features, such as exceptional interspecies cross-reactivity and binding affinity, which allows for preclinical disease animal model studies that have increased clinical relevance, according to a company press release.

Genuv is also developing GNUV205, an improved interleukin-2-based immunocytokine anticancer drug that is made tumor-specific by leveraging the properties of GNUV201.

“We are excited to embark on our mouse platform business with Celltrion as our first partner,” said Sungho Han, founder and CEO of Genuv, in the press release. “We believe Celltrion's in-depth knowledge and experiences in antibody development and production and Genuv's expertise in novel antibody discovery with our SHINE MOUSE platform could generate great synergies in providing innovative antibody therapeutics.”

“Celltrion is continuously interested in antibody-based new drugs and anticipates to discover differentiated antibodies through innovative antibody discovery platform technology. We look forward to partnering with Genuv for the development of innovative antibody therapeutics that will bring new hope to patients with high unmet needs,” said Kisung Kwon, head of the R&D unit of Celltrion, in the release.

The collaboration between Genuv and Celltrion will utilize Genuv's proprietary mouse platform for antibody discovery.

Genuv and Celltrion Partner on Development of Novel Therapeutic Antibodies

On March 10, 2023, FDA approved US-based Acadia Pharmaceuticals’ Daybue (trofinetide), an oral solution for treating a rare genetic disease. According to an agency press release, the drug is the first treatment for Rett syndrome, a rare, genetic neurological disorder. The drug is indicated for treating adult patients and children two years of age or older who have the condition.

Rett syndrome affects the way the brain develops, and patients with this disorder experience a progressive loss of motor skills and language. A hallmark symptom of Rett syndrome is near constant repetitive hand movements, such as rubbing or clapping. The disorder, which primarily affects females (1 in 10,000) and even more rarely affects males, leads to severe impairments that affect nearly every aspect of life, including speaking, walking, eating, and breathing.

Daybue’s efficacy and safety were evaluated in a randomized, double-blind, placebo-controlled, 12-week study (Study 1; NCT04181723) involving patients with Rett syndrome at five to 20 years of age. Patients treated with the drug demonstrated a statistically significant difference compared to placebo on co-primary efficacy endpoints, according to the agency press release.

The drug is expected to be available in the United States by the end of April 2023, according to an Acadia Pharmaceuticals company press release. Acadia entered into an exclusive license agreement with Neuren Pharmaceuticals in 2018 for the development and commercialization of trofinetide in North America for the Rett syndrome indication as well as other indications.

“Rett syndrome is a profoundly debilitating and complex, rare, neurodevelopmental disorder that presents differently across patients and can lead to an array of unpredictable symptoms throughout the course of a patient’s life,” said Jeffrey L. Neul, Annette Schaffer Eskind chair and director, Vanderbilt Kennedy Center, professor of Pediatrics, Division of Neurology, Pharmacology, and Special Education, Vanderbilt University Medical Center, and Phase III study (LAVENDER) investigator, in the Acadia Pharmaceuticals press release. “Now, for the first time after decades of clinical research, healthcare providers finally have a treatment option to address a range of core behavioral, communication, and physical symptoms for their patients living with Rett syndrome.”

FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.