Maravai Lifesciences Expands Its Contract Development and Manufacturing Organization (CDMO) Capabilities at Trilink Biotechnologies

Maravai Lifesciences | August 25, 2020

Maravai LifeSciences, a global provider of life science reagents and services to researchers and biotech innovators, is expanding its contract development and manufacturing organization (CDMO) capabilities at TriLink BioTechnologies for the second time in less than a year. The expansion is expected to be completed in the first quarter of 2021 and will increase TriLink's small molecule manufacturing capacity with a focus on additional scale-up of CleanCap®, its proprietary messenger RNA (mRNA) capping technology, for global mRNA vaccine and therapeutic programs. To further address the increasing demand for mRNA development and clinical programs, the company is currently completing the construction of its plasmid DNA production facility as well. Last November, TriLink opened their new headquarters in San Diego, CA and expanded mRNA and small molecule capacity as it opened five Current Good Manufacturing Practice (cGMP) suites. The current investment will further expand the operation with an additional three cGMP suites and four cGMP manufacturing support suites.

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Applikon Biotechnology is a world leader in developing and supplying advanced bioreactor systems from laboratory scale to production scale. We are the only company that can take a customer from the initial screening stage up to full-scale production using the same platform. This minimizes scale-up risks and guarantees the shortest time to market for our customers' new product development.

Spotlight

Applikon Biotechnology is a world leader in developing and supplying advanced bioreactor systems from laboratory scale to production scale. We are the only company that can take a customer from the initial screening stage up to full-scale production using the same platform. This minimizes scale-up risks and guarantees the shortest time to market for our customers' new product development.

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INDUSTRIAL IMPACT

Ecological Laboratories, Inc. announces acquisition of TOMCO Chemical to Bolster Reach into Hog Farming Waste Management.

Ecological Laboratories, Inc. | July 08, 2022

Ecological Laboratories, Inc. a Biotechnology company that develops and manufactures novel, proprietary, liquid microbial formulations capable of solving many of the most challenging environmental problems, announced that it has acquired TOMCO Chemical. TOMCO Chemical has provided bacterial products specifically to breakdown solids and reduce odors for Hog Farms in the United States. "We are thrilled to bring together the TOMCO team with Ecological, which gives us critical mass to research, support and deliver against producer's farm waste challenges today and tomorrow." Ecological's CEO Nick Favret Ecological Laboratories, Inc. has been servicing the Hog Farming Waste Management Industry for more than forty years. By acquiring TOMCO, Ecological will be able to reach more farming leaders looking to use Biologically friendly solutions moving forward. TOMCO's premier product Pit-Perfect, a component of their In-Gest-O-Bac product series has been a tool used by farmers with great success. As Bio-Gas and Sustainable Agriculture continue to scale globally, Ecological recognizes the further demand of their microbial solutions. Ecological's Farm Waste Management solutions under the brand MICROBE-LIFT is the most effective way to improve farm waste processes. With unmatched capabilities to breakdown waste, and reduce toxic gases. MICROBE-LIFT technology drives down costs, increases operation efficiency, provides return on investment and supports regulatory compliance. "I am proud to announce the merger of TOMCO Chemical and Ecological Laboratories, Inc. By joining forces with Ecological we have the capacity to bring the best solution in waste management to a level that has not been seen before", said Tom Elsner President & CEO of TOMCO Chemical. Ecological Laboratories, Inc. continues to innovate with our propriety microbial formulations focusing on solutions for the Commercial Waste Water, Farm Waste, Aquaculture, Composting, Eco-System Restoration and Bio Gas Industries as well as the Retail Water Garden, Lawn and Garden, Aquarium, Pet, Hydroponic and Septic markets.

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INDUSTRIAL IMPACT

Enveric Biosciences Advances Drug Development for Mental Health Indications and Intellectual Property Portfolio

Enveric Biosciences, Inc | July 14, 2022

Enveric Biosciences, Inc. a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, today revealed drug discovery and development progress targeting mental health indications and intellectual property advances achieved during the first half of 2022. “The first half of 2022 was foundationally successful for Enveric. We validated and executed on the corporate premise that we can deploy PsyAITM, our proprietary artificial intelligence tool, and PsybraryTM, our expanding proprietary portfolio of new chemical entities and drug candidates, to design and improve upon new drug molecules inspired by legacy psychedelic drugs,” Dr. Joseph Tucker, PhD, Enveric’s Chief Executive Officer “Enveric is pleased to advise that our predictions have materialized, and our platforms have successfully generated a large number of promising new molecules that have successfully passed primary screening and moved on to lead optimization, providing us with a strong slate of drug candidates. Our leading program, EVM-201, includes a number of new molecules currently in lead optimization that are geared towards providing improved characteristics and drug-like properties compared with psilocybin. The successful outcomes from our testing efforts completed in the first half of 2022 have positioned the company very well to advance our drug candidates towards the clinic,” continued Dr. Tucker. Clinical-Need Driven Based on extensive direct clinical understanding of the current unmet needs in anxiety, depression, PTSD, and other mental health indications, coupled with in-depth knowledge of the current treatment landscape, Enveric’s Clinical Team is well positioned to tackle the challenges ahead, while aiming to shepherd novel new treatments for a host of mental health indications. Enveric’s Clinical Team is led by a past Board-certified psychiatrist and clinical trialist Chief Medical Officer, Dr. Bob Dagher, MD. Dr. Dagher joined Enveric in December 2021, bringing a wealth of clinical trial management and new CNS-drug development experience from his past roles, including at WCG, Cadent, Covance, Sanofi and GSK, in addition to his first-hand experience in treating patients from his previous clinical practice in psychiatric medicine. Next-Generation Drug Discovery Enveric’s Discovery Team, spearheaded by Chief Innovation Officer Dr. Peter Facchini, PhD, an international leader in natural product biochemistry and biotechnology, completed the rational design of more than 300 Generation-2 (“Gen-2”) psilocin prodrug candidates using well-established design strategies, but adapted to the unique structure of psilocin. The 300 Gen-2 original concept designs, now housed within the PsybraryTM, were screened using PsyAITM. The assessment helped predict chemical structures with appropriate receptor binding, toxicology, and pharmacokinetic profiles that would trigger the desired mechanisms of action while reducing undesirable side effects, and the initial candidate evaluation included, among other metrics, prodrug-likeness, toxicity, ease of chemical synthesis and degree of IP-white space surrounding the molecule. Ranked scoring of these and other AI assessments, as well as commercial considerations (e.g., ease of procuring synthetic starting materials), prioritized 31 novel Gen-2 molecules that have been synthesized in sufficient quantities (~10 mg, 95% purity) for preliminary pharmacological screening. Enveric’s Chemistry Group, led by Dr. Kaveh Matinkhoo, PhD, completed these syntheses, 29 of which were deemed stable enough to advance. Deep-dive chemical structure searches, patentability, and freedom-to-operate reviews were performed on all 29 candidates, under the leadership of Lead Internal Counsel C. Michael Gegenheimer. All the patentability analyses indicated potential patentability results, and 25 of the 29 molecules presented minimal concern with freedom to operate. To strengthen the IP protection for the overall Gen-2 prodrug program, three provisional patent applications, covering 7 structurally diverse clinical classes and thousands of additional potential new drug candidates, have been filed so far in 2022, and additional provisional and PCT filings are expected to continue throughout the year. In other IP developments, an additional three of Enveric’s international patent applications protecting tryptamine derivatives have been published by the World Intellectual Property Organization, bringing the total published so far to seven. EVM-201 Drug Candidate Testing Following the initial Gen-2 ideation, patent filing, synthesis, and screening efforts, more extensive assays were performed on the advancing drug candidates. Numerous internal assays were performed under the leadership of Dr. Jill Hagel, PhD, Vice-President of Innovation and Dr. Sheetal Raithatha, PhD, Director of Research and Development. The internal results were then confirmed and validated using leading independent, third-party Contract Research Organizations (CROs), covering 122 Toxicology tests, 72 receptor-binding and potency tests, 31 pharmacokinetic tests and 24 animal-model tests to provide ample information to support candidate nomination. The synthesis and analysis of these comprehensive pharmacology and toxicology datasets, both internal and external, was led by Dr. Kevin Leach, PhD DABT, Vice President of Preclinical and Translational Research. Enveric is now moving towards lead-candidate nomination and, in preparation for IND filing, has initiated numerous IND-enabling studies on several of the leading candidates at third-party CROs. Recognizing the need for stable drugs with robust, reproducible, and cost-effective manufacturing, several Contract Development & Manufacturing Organizations (CDMOs) are currently engaged with Enveric’s Chemistry Team to determine how best to manufacture our molecules. Enveric has plans in place to produce material at commercial facilities and the CDMO personnel have worked with our chemists to validate that our processes will work at their facilities. This is another necessary step prior to filing the IND. Finally, preliminary formulation work is underway, with a particular focus on enabling improved routes of administration. “The first half of the year has indeed been busy and productive for the dedicated team here at Enveric. We are all very excited at how those efforts have begun to bear fruit. We look forward to advising our shareholders of further key developments, which we anticipate will continue to unfold during the remainder of 2022,” concluded Dr. Tucker. About Enveric Biosciences Enveric Biosciences, Inc. is a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines. Enveric's robust pipeline supports drug development from the clinic to commercialization aimed to help millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more.

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MEDICAL

Be Bio and Resilience Announce Strategic Collaboration to Manufacture Engineered B Cells, a New Class of Cellular Medicines

Be Bio | May 20, 2022

Be Biopharma, Inc. (“Be Bio”) and National Resilience, Inc. (Resilience) today announced a strategic collaboration to advance initial programs in Be Bio’s rare disease pipeline. Be Bio’s proprietary engineered B Cell Medicines (BeCM) platform is harnessing the power of the human B cell to create a new class of autologous and allogeneic cellular medicines that durably and redosably produce therapeutic proteins in vivo without toxic pre-conditioning. The two companies are investing to drive innovation and reliability in cell therapy manufacturing, a critical success factor for broad and meaningful patient impact. As part of this unique partnership, Resilience will dedicate personnel solely to produce and supply Good Manufacturing Practices (GMP)-grade viral vector and cell therapy drug product for the initial programs in Be Bio’s rare disease pipeline. Through a creative cost and risk-sharing model, Resilience will be responsible for manufacturing costs and receive potential future milestones and royalties. Over the past year, Be Bio has built a strong foundation with our BeCM platform, pipeline, team, and recent $130 million financing. Manufacturing is critical to rapidly progress our BeCMs to the clinic and we have built non-GMP manufacturing capabilities in our Cambridge facility. This deal allows us to drive GMP manufacturing with an outstanding partner, and in a capital efficient manner, Resilience’s broad manufacturing capabilities, strong collaborative spirit and dedicated resources to our platform, make them an ideal partner for our BeCM programs.” Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio. Resilience will lead clinical GMP manufacturing of both the viral vector and the cell therapy drug product for Be Bio’s initial rare disease programs to support first-in-human clinical trials. Resilience will apply its pioneering bioprocessing solutions and network of cell therapy sites, including facilities in Research Triangle Park, NC, Philadelphia, PA, Waltham, MA and Marlborough, MA to conduct the work. This collaboration shows our excitement for the promising science of Be Bio’s proprietary BeCM platforms, and our confidence in their expertise to deliver transformative cell therapies, By working alongside Be Bio early in the drug development process, we aim to accelerate the development of their B cell medicines with the potential to unlock a pipeline of product candidates across a variety of serious diseases.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. About B Cells – A New Class of Cellular Medicines Imagine what could “Be?” In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas. About Be Biopharma Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BeCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy. About Resilience Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.

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