GMP

Alvotech Appoints Interim Chief Quality Officer

Retrieved on: 
Thursday, February 29, 2024

REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer.

Key Points: 
  • REYKJAVIK, Iceland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Christina Siniscalchi will join its corporate leadership team as interim Chief Quality Officer.
  • Christina Siniscalchi has for over ten years served in senior quality positions for Alvogen and its manufacturing site in Norwich, NY, most recently as Alvogen’s Chief Quality Officer.
  • “We thank Sandra for her valuable contribution to Alvotech, as she successfully steered our quality team through the recent FDA facility inspection, which now has led to the approval of our interchangeable high-concentration biosimilar to Humira in the U.S.,” said Robert Wessman, Chairman and CEO of Alvotech.
  • Continuous improvement, quality, and compliance, is at the heart of everything we do.”
    Christina Siniscalchi has 25 years of experience in the U.S. pharmaceuticals industry.

Pluri’s Innovation Across Various Industries: CEO Updates on Recent Achievements & 2024 Goals

Retrieved on: 
Wednesday, February 28, 2024

Leveraging our proprietary 3D technology platform, our new vertical PluriAgtech can create high-quality cell-based coffee with 98% less water than traditional coffee production.

Key Points: 
  • Leveraging our proprietary 3D technology platform, our new vertical PluriAgtech can create high-quality cell-based coffee with 98% less water than traditional coffee production.
  • We also estimate that our innovative new production process will reduce the amount of growing area by 95%, potentially preventing deforestation.
  • By creating novel cell-based products both independently and through partnerships, Pluri is showing what’s possible when we all work together.
  • As such, our transformative technology is not only creating long-term value for our shareholders; it’s also making the world a better place.

Optimi Announces Closing of First Tranche of Non-Brokered Private Placement

Retrieved on: 
Wednesday, February 28, 2024

The Company intends to use the net proceeds from the Offering to obtain its Drug Establishment License, facilitate commercialization, and for general working capital.

Key Points: 
  • The Company intends to use the net proceeds from the Offering to obtain its Drug Establishment License, facilitate commercialization, and for general working capital.
  • JJ Wilson and Dane Stevens, co-founders of Optimi, emphasize, “We are fully dedicated to Optimi's mission of becoming the leading end-to-end supplier of GMP psychedelics.
  • In addition to the financing, the Company also announces that specific founders have agreed to a one-year voluntary lock-up period for their founder shares.
  • This additional commitment, along with the founders' participation in the financing, emphasizes their dedication to commercializing the business and establishing sustainable markets for its products.

Immunocore reports fourth quarter and full year 2023 financial results and provides a business update

Retrieved on: 
Wednesday, February 28, 2024

Selling, general and administrative (SG&A) expenses for the year 2023 were $144.5 million, compared to $123.1 million for the year 2022.

Key Points: 
  • Selling, general and administrative (SG&A) expenses for the year 2023 were $144.5 million, compared to $123.1 million for the year 2022.
  • The fourth quarter basic and diluted loss per share was $0.40, compared to $0.64 for the fourth quarter of 2022.
  • Topline data from the Phase 2 portion of the trial is expected to be available by the fourth quarter of 2024.
  • Immunocore will host a conference call today, February 28, 2024 at 8:00 A.M. ET/ 1:00 PM GMT, to discuss the fourth quarter and full year 2023 financial results and provide a business update.

Samson Extracts Processes Over 1 Million Lbs of Hemp Biomass in 2023

Retrieved on: 
Tuesday, February 27, 2024

GENEVA, Ala., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Samson Extracts (“Samson” or the “Company”), an Alabama-owned and operated manufacturer of bulk CBD products, announced that it processed over one million pounds of hemp biomass in 2023.

Key Points: 
  • GENEVA, Ala., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Samson Extracts (“Samson” or the “Company”), an Alabama-owned and operated manufacturer of bulk CBD products, announced that it processed over one million pounds of hemp biomass in 2023.
  • This milestone achievement places Samson within the top ten hemp processors by biomass extraction volume in the United States, with the company’s full spectrum CBD distillate (FSD) distributed nationally to many of the country’s top hemp and cannabis operators and wholesalers.
  • Samson Extracts utilizes a GMP-certified, complex industrial-scale extraction system to produce winterized and decarbed crude FSD for a diverse range of products.
  • “This milestone accomplishment in our company history is only the beginning of what is to come from Samson,” said Kyle Neathery, CEO of Samson Extracts.

Telix Expands U.S. Development and Manufacturing Infrastructure with Acquisition of IsoTherapeutics

Retrieved on: 
Monday, February 26, 2024

Founded in 2005, IsoTherapeutics is a privately held, commercial-stage company, which provides radiochemistry and bioconjugation development and contract manufacturing services to many companies in the radiopharmaceutical industry, including Telix.

Key Points: 
  • Founded in 2005, IsoTherapeutics is a privately held, commercial-stage company, which provides radiochemistry and bioconjugation development and contract manufacturing services to many companies in the radiopharmaceutical industry, including Telix.
  • In line with Telix’s continued investment in the vertical integration of supply chain, manufacturing and development capabilities, the acquisition is expected to further enhance Telix’s in-house drug development capabilities.
  • A key driver for the acquisition is to enable Telix to bring select aspects of its development programs in-house, with the goal of reducing cost and time to achieve technical milestones.
  • The acquisition will also expand Telix’s U.S. manufacturing footprint with a site that includes a GMP1 clean room and production infrastructure suitable for clinical use.

PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia

Retrieved on: 
Wednesday, February 21, 2024

In pursuit of its clinical strategy for PD-001, Sairiyo is establishing a wholly-owned subsidiary in Australia to conduct the proposed Phase 1 study and capitalize on drug development incentives in Australia.

Key Points: 
  • In pursuit of its clinical strategy for PD-001, Sairiyo is establishing a wholly-owned subsidiary in Australia to conduct the proposed Phase 1 study and capitalize on drug development incentives in Australia.
  • Sairiyo could earn a 43.5 percent rebate from the Australian Federal Government’s Research and Development tax incentive program.
  • Sairiyo has commenced working on a regulatory application to the TGA for its proposed Phase 1 study in Australia.
  • We expect to submit the regulatory package to the TGA for a proposed Phase 1 clinical study in Australia in Q2-2024.”

Immix Biopharma 12 Month Review Progress Update

Retrieved on: 
Wednesday, February 21, 2024

LOS ANGELES, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.

Key Points: 
  • LOS ANGELES, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.
  • “The past 12 months have seen landmark achievements for Immix Biopharma, cementing our position as a leading cell therapy company in autoimmune disease.
  • NXC-201 is the first and only ‘Single-Day CRS‘ CAR-T, a critical advancement for autoimmune diseases like AL Amyloidosis,” said Ilya Rachman, MD PhD CEO Immix Biopharma.
  • As we reflect on the last 12 months of progress, we wish to connect with you offering an update on Immix Biopharma.

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Tuesday, March 12, 2024

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Key Points: 
    • 16

      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

      17

      Table of contents

      18

      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
      15

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

      66

      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

    • 71

      Recommendations are made on the clinical development, potential study designs and safety

      72

      considerations for allergen products within the scope of the guideline.

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

      94

      quality and clinical development according to the current knowledge.

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      in moderate to low-sized study populations
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      127

      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

      128

      conditions will require separate clinical trials (see Section 6).

    • 129

      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

      130

      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

      131

      substantially to the allergen products as discussed above.

    • 1

      156

      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

      157
      158

      of allergic diseases - CHMP/EWP/18504/2006
      ?

      159
      160
      161

      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

      ?

      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

      199

      case, a reduced validation should include all relevant manufacturing process steps that are considered
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      in moderate to low-sized study populations
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      product specific.

    • 290

      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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      intracutaneous or provocation testing.

    • 298

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      7.1.

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      in moderate to low-sized study populations
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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

      378

      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

      376

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

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      455

      8.2.1.

    • 493

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      In general, sensitivity and specificity of the product should be determined.

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      10.2.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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Preliminary QIG Considerations regarding Pharmaceutical Process Models

Retrieved on: 
Tuesday, March 12, 2024

6

Key Points: 
    • 6

      Preliminary QIG Considerations regarding Pharmaceutical
      Process Models

      7

      Background

      8

      This Quality Innovation Group (QIG) document follows on from the first QIG Listen & Learn Focus

      9

      Group (LLFG) on Continuous manufacturing and the second QIG LLFG on Digital novel technologies,

      5

      10

      held on 13 March 2023 and 12-13 October 2023 respectively.

    • 12

      It is recognised that regulatory expectations for process models in pharmaceutical manufacturing are

      13

      evolving; the intent of this document is to share QIG?s current thinking with stakeholders and seek

      14

      their comments.

    • This, in turn, supports adoption of advanced process

      25

      control strategies, continuous process verification, real-time process monitoring and optimisation, and

      26

      automated or even autonomous operation and management of manufacturing processes.

    • Process

      27

      models play an increasingly important role in process design and validation, in control strategies and

      28

      during manufacturing process lifecycle.

    • The expected outcome from the use of process models is

      29

      enhanced process understanding, (multivariate) monitoring and control, robustness, performance and

      30

      adaptability.

    • 31

      A model (in the context of pharmaceutical manufacturing) is a mathematical representation of a

      32

      physical or biological process or system.

    • Empirical models (e.g., multivariate models used for Statistical Process Control, regression models

      39

      derived from data collected from Design of Experiments), and

      40

      3.

    • 45

      Scope

      46

      This document addresses preliminary considerations (general principles) for process models, reflecting

      47

      the use of performance-based approaches in pharmaceutical manufacturing processes.

    • 48

      The scope of this document is limited to process models such as first-principle models, regression

      49

      models, system models, multivariate statistical process control models, and Machine Learning models

      50

      (ML).

    • Complex datasets need not be
      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      submitted.

    • 137

      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      Of note, these are just examples.

    • Process validation for finished products ? information and data to be provided in regulatory submissions
      (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1)
      Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory
      submission (EMA/CHMP/BWP/187338/2014)
      4
      5

      Preliminary QIG Considerations regarding Pharmaceutical Process Models
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      Some models may have a dual purpose e.g., used for process development and used as part of the

      164

      control strategy e.g., to set control limits.

    • 200

      Process validation (as described in the process validation guidelines) has an overarching role to ensure

      201

      that the process consistently delivers material of the intended quality.

    • Depending on the model risk, a model verification protocol may be requested,
      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      209

      including the model performance metrics and the manufacturing process IPC and CQAs that should be

      210

      followed, the respective acceptance criteria, the number of additional data (independent) that would be

      211

      used, and the monitoring period (parallel testing).

    • Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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