Pharmaceutical Technology Editors

LG Chem Life Sciences (LG Chem), the life sciences division of the South Korean LG Group, is moving forward with investigational new drug (IND)-enabling studies that prompted the company to exercise its renewal option as part of an ongoing collaboration with Avacta Group, a clinical stage biopharmaceutical company. The renewal option has triggered a license renewal fee payment of $2 million to Avacta, according to a June 30, 2022 company press release.

Under the agreement, LG Chem has the exclusive rights to develop and commercialize Avacta’s Affimer programmed death ligand 1 (PD-L1) inhibitor with Affimer XT serum half-life extension on a global basis and for a range of indications. LG Chem will progress the PD-L1/XT candidate by starting pre-clinical studies, which are intended to form the basis of an IND submission.

Avacta and LG Chem had entered into a multi-target development agreement in December 2018 to develop Affimer therapeutics in several disease areas. In 2020, the companies expanded their partnership to include Avacta’s Affimer XT technology, which can be used to control the amount of time a drug spends in the blood, according to the press release.

“The initiation of IND-enabling studies represents a significant step towards first-in-human clinical trials of the Affimer platform, which is a key value driver for the technology and for Avacta,” said Alastair Smith, CEO, Avacta Group, in the release.

Articles

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

LG Chem Renews License with Avacta for IND Studies

Colder Products Company’s AseptiQuik G DC Series Connector is designed to connect and disconnect tubing aseptically through a single, sterile connection. The latest in the company’s AseptiQuik G line of genderless sterile connectors, the product can make quick sterile connections and disconnections in both sterile and non-sterile environments without requiring any ancillary equipment.

The AseptiQuik G DC connector’s “FLIP-CLICK-PULL” assembly is designed to help users transfer liquids easily. After transfer is complete, a simple two-step disconnection process maintains system sterility. AseptiQuik G DC connector hose barb termination sizes include quarter inch, three-eighth inch, and half-inch sizes.

The AseptiQuik G DC connector is a single, sterile connection technology that can connect and disconnect tubing aseptically.

Aseptic Tubing Connector

HEMCO’s UniFlow Radioisotope Fume Hood 

HEMCO’s UniFlow Radioisotope Fume Hood is designed to meet strict requirements for lab work involving radiochemicals. The product is constructed with a welded one-piece seamless type 304 stainless-steel interior fume chamber with all corners coved for easy cleaning. The work surface is welded to the fume chamber liner and reinforced to support weight loads associated with isotope work, such as lead barriers and equipment.

The fume hoods come in 48-inch, 60-inch, and 72-inch widths and can be outfitted with various accessories such as service fixtures, electrical service options, cabinets/tables, and suitable exhaust blowers to safely remove hazardous fumes or particulates. LED lighting and a vertical slide tempered glass sash are also included.

The ROSS Mixing/Melting and Holding Tank System can generate up to 10 psig internal pressure to produce potent and reactive materials. 

Radiochemical Fume Hood

Steriline’s Robotic Nest Filling Machine

Steriline’s Robotic Nest Filling Machine is designed to aseptically process injectable drugs in a more efficient, safe, and flexible manner than traditional alternatives. By minimizing human intervention, the machine aims to produce a higher quality product with fewer operator mistakes.

The machine automatically adapts its process to recipes that have been registered in its database. Once a specific container is registered in this database, special sensors in the machine can detect the type and capacity of the containers. These sensors can also identify any non-compliant pieces and manage them without technician intervention, reducing waste and downtime.

The machine is capable of processing vials, ampoules, cartridges, syringes, and bags, and can handle toxic or non-toxic products in both liquid and powder form. It can be equipped with laminar air flow, open and closed restricted access barriers, and isolator barrier systems.

Steriline’s Robotic Nest Filling Machine is designed to minimize human intervention in aseptic processing of injectable drugs. 

Robotic Injectable Drug Processor

ROSS Mixing/Melting and Holding Tank System

The ROSS Mixing/Melting and Holding Tank System is a custom-designed machine that can produce highly potent and reactive materials at 350 °F and up to 10 psig internal pressure. The system includes a pressure-rated sealed enclosure with an operator-friendly safety glovebox and two mixers each equipped with a two-wing anchor agitator, Teflon scrapers, and jacketed six-gallon vessel.

A specially designed elevator system enables the mixers to be lowered to a maintenance position and raised to an operating height which allows for gravity feed from the melter to the holding tank. It also comes equipped with a hot oil heater and chilled water cooler.

Fully Enclosed Mixing/Melting System

On June 30, 2022, Getinge announced the release of its new DPTE-EXO with Sleeveless DPTE-BetaBag, which offers more secure aseptic transfer. According to a company press release, the product it a first-of-its-kind alpha port that comprises an external opening and an integrated funnel. The design is aimed at securing automated aseptic transfer and improving operational efficiencies.

The new port addresses the need posed by the biopharma industry’s rising demand for throughput and automation as well as stricter good manufacturing practice requirements. The combination of a motorized external-opening alpha port with an optional funnel provides operational efficiency by reducing manual intervention. This design also frees up time for the operator. The product is a fully validated and interlocked system and, with the dismountable funnels, offers a total transfer solution from the outside to the process area. Having the external opening significantly reduces the risk of contamination, and the connectivity offers a greater degree of traceability and data analysis.

“As the industry evolves, the next generation of pharmaceutical manufacturing needs greater flexibility of the batch’s size to switch production quickly from one drug to another,” said Anneke Evers, senior director, DPTE Sales & Market Support, Getinge, in the press release.

“DPTE-EXO with Sleeveless DPTE-BetaBag supports the efforts to build safe, automated, and compliant filling lines. It’s easy to use and has several smart controls governing its safe and efficient door opening and closing and funnel movements. It also integrates a specific program with an open door and funnel position suitable for the barrier system bio-decontamination cycle,” Evers also said in the release.

Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.