Webinars

Biosynthesis of Chiral Compounds at Hiray Pharma Solutions

02.16.23

Enzymatic biocatalysts can be expertly designed to catalyze the synthesis of chiral compounds in highly efficient, specific, and selective manners as compared to classical chemical synthesis. This webinar will offer a representative look at some of the research and CDMO projects executed by Hiray Pharma Solutions’ Laboratory of Biocatalysis and Enzyme Engineering. A fundamental background of the science, challenges, and advantages of these projects will be provided. In addition, this webinar will feature a brief tour of Hiray’s brand new small molecule manufacturing facility on the company’s 35-acre campus in Jingmen, China. A brief conclusion will follow along with responses to some key questions which have recently been asked of Hiray.

Speakers:

Mika Kwan - Project Manager - R&D
Hiray Pharma Solutions

Kavuluru Venkata Hemakumar - Technical Support Manager - Technology Department
Hiray Pharma Solutions

Tim Miley - VP of Business Development - North America
Hiray Pharma Solutions

New Approaches in Bispecific Antibody Development

01.25.23

An emerging class of next-generation antibodies, bispecific antibodies (bsAb) can create a wide range of applications to meet the current unmet needs of patients. In this webinar, we will introduce S-DUAL bispecific antibody platform that enables high purity, thermostability, and manufacturability by eliminating mispairing risks, while maintaining high-quality structure for your novel finding.

Speaker:

Jina Kim
Senior Scientist of Bio R&D Center - Samsung Biologics

Application of Risk-Based Approach in a ATMPs Multi-Product Facility

12.08.22

ATMPs are complex products and risks may differ according to the type of product and level of complexity of the manufacturing process. The risk-based approach facilitates the manufacturer to design the organizational and technical measures that are put in place to comply with GMPs and thus to ensure quality according to the specific risks of the product and the manufacturing process. While the risk-based approach brings flexibility, it also implies that the manufacturer is responsible to put in place the control measures that are necessary to address the specific risks of the product and of the manufacturing process, and to demonstrate the aseptic capability of such processes.

Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1

11.10.22

A Science-Based Holistic Approach

The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, was finalized on 25 August 2022 and includes new requirements for ensuring the container closure integrity (CCI) of sterile pharmaceutical products. This webinar will present how sterile product manufacturers can prepare themselves for the new regulations, a science-based holistic approach to ensure good CCI and include a description of CCIT methods that can be used for frozen products needing cold chain storage and transport.

Learn in detail how the new requirements of the revised EU Annex 1 may impact your strategy for ensuring the container closure integrity (CCI) of sterile pharmaceutical products.
Gain understanding of the advantages and disadvantages of container closure integrity testing methods and why a science-based holistic approach to ensure good CCI is important.
Learn how cold chain storage and transport can impact the CCI of sterile pharmaceutical products.

Release & Stability Testing Requirements for Parenteral Drug Products

11.03.22

Parenteral products are sterile drugs, solutions, emulsions and suspensions. Parenteral products are unique from any other type of pharmaceutical dosage form for the following reasons: All products must be sterile and free from pyrogenic (endotoxin) contamination.

Release and stability testing are a vital part of new drug development and is conducted throughout a product’s life cycle. These studies confirm that the quality, safety, and effectiveness of drug products are preserved all through the shelf life as an essential requirement. This presentation will provide a brief overview of the parenteral drug products release testing as well as the ICH guidelines for stability testing.

Expansion and Preparedness for the Post-Pandemic

10.25.22

Topics that will be addressed:

Market trends - supply & demand in biopharmaceutical manufacturing
Beyond COVID - diversified modalities, challenges and supply chain
What you should look for in a CDMO

HPAPI Safety Solutions to Augment Containment SOPs

10.13.22

In this educational webinar, you will learn about various PAPR (Powered Air Purifying Respirators) respiratory solutions to augment and enhance current flexible containment systems. PAPRs offer a reliable, scientifically valid means to safely handle HPAPI and offer protection in many other pharmaceutical applications, such as aseptic processing and LAR. Protection, comfort, and value are critical components to any PAPR system and SOP. Join us to learn about positive pressure systems and the how they provide superior comfort and operator-usability when compared to masks; plus, you’ll take away the following:

An understanding of protection factors required for your application
An overview of various cartridge options available contingent on hazard
The benefit of no required fit testing
Availability of 10~6 sterility assurance head tops for cleanrooms
New technologies for available for lighter duty filling and handling

Platform Based Scalable Suspension Process for LVV Production

09.29.22

Lentiviruses have been widely used for cell therapy based applications. This presentation will showcase IDT Biologika’s platform based approach for Lentiviral Vector production.

Additionally, analytical methods for determining both the physical and functional titer will be described, which are used to assess the efficiency of Lentiviral Vector production.

The strategies described here will enable a scalable and robust process that focuses on suspension transient transfection of serum free HEK cells.

8 Trends in Contract Manufacturing

09.15.22

The trend toward outsourcing pharmaceutical development and manufacturing has accelerated during COVID as pharma companies — both in the US and abroad — seek to streamline their own facilities, focus on core competencies and avoid product delays inherent in overseas manufacturing. Partnering with a CDMO allows them to access more specialized knowledge, state-of-the-art equipment and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

As both a CDMO and a manager of CMOs, Avéma Pharma Solutions sees a number of trends emerging that CDMOs must embrace to be successful including: