NextPharma Acquires Lonza Sites; Catalent Divests BFS Sterile CDMO Biz

The latest from CDMOs, CMOs, and suppliers featuring Lonza, NextPharma, Catalent, Piramal Pharma Solutions, Asymchem, Aji Bio-Pharma, Rentschler Biopharma, and others.

Chemicals/Chemical API Manufacturing

Asymchem Expands Oligonucleotides Mfg Capacity
Asymchem, a Morrisville, North Carolina-based CDMO, has expanded its active pharmaceutical ingredient (API) manufacturing facilities in China to provide peptide and oligonucleotide products.

The initial oligonucleotide commercial-scale production site will comprise 5,775 square meters as an expansion of Asymchem’s existing small-molecule API facility in Tianjin, China. The GMP facility will accommodate gram to metric ton production scales. Phase I of the facility is scheduled to be fully operational in the third quarter of 2022 and will include an oligo process production line with an annual capacity of 50 kg to 100 kg. The Tianjin site has the capacity to accommodate 12 or more oligo process production lines.

Source: Asymchem

Piramal To Acquire Peptide Producer Hemmo Pharmaceuticals
Piramal Pharma Solutions, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has agreed to acquire a 100% stake in Hemmo Pharmaceuticals, a Mumbai, India-based company that develops and manufactures peptide APIs, for an upfront consideration of INR 775 crores ($105 million) and earn-outs linked to achievement of milestones.

Hemmo has more than 38 years of experience in supplying peptide products and custom peptide synthesis. The company has strong expertise in both solution-phase and solid-phase synthesis of peptides. This acquisition marks Piramal’s entry into the development and manufacturing of peptide APIs.

The acquisition is expected to add more than 250 employees to Piramal. The acquisition agreement is subject to customary regulatory closing conditions.

Source: Piramal Pharma Solutions

KD Pharma Acquires Mfg Assets
The KD Pharma Group, a Bexbach, Germany-based contract pharmaceuticals and nutraceuticals, has acquired the manufacturing assets of Rohner AG, a former CDMO of fine chemicals and active pharmaceutical ingredients (APIs) based in Pratteln, Switzerland.

The KD Pharma Group has an existing CDMO site in the UK, a contract softgel manufacturing site in the US, and omega-3 manufacturing sites in Norway and Germany. The acquired Rohner assets will allow KD Pharma to further expand its pharmaceutical CDMO business. In addition, KD Pharma has hired several personnel from the former Rohner team.

Source: KD Pharma

Biologics Manufacturing

Rentschler Biopharma Names New CEO of US Subsidiary
Rentschler Biopharma SE, a Laupheim, Germany-based biologics CDMO, has appointed Dr. Martin Kessler as Chief Executive Officer (CEO) of Rentschler Biopharma Inc., the company’s wholly owned US subsidiary, and as Senior Vice President, Transformation, of Rentschler Biopharma SE.

Dr. Kessler brings more than 15 years of experience in pharmaceutical and biopharmaceutical operations and strategy. In his role as head of the US business, he will lead the ongoing expansion at the company’s Greater Boston area site, which includes expanding capabilities, capacity, and talent.

Dr. Kessler has held several leadership positions in the industry and in the consulting business before joining Rentschler Biopharma. In his last position, he was Associate Partner at McKinsey & Company and led the medical-device operations practice in Europe. He served leading pharma, biopharma, and med-tech companies in optimizing operations, specifically, supply chain, manufacturing, and quality. Dr. Kessler brings additional expertise in strategy and portfolio optimization as well as clinical development, including in the mRNA space. As a consultant, he has been working with Rentschler Biopharma across a variety of areas, including operations transformation, strategic innovation, and overall strategy for the US site.

Source: Rentschler Biopharma

mAbxience To Expand Biologics Mfg Capacity
mAbxience, a biosimilars company and biologics CDMO, is increasing its biomanufacturing capacity at its site in León, Spain through the addition of a 4,000-L single-use bioreactor system. The system will be commissioned in mid-2021 and will increase manufacturing capacity for biosimilars and CDMO projects.

Source: mAbxience and ABEC

Chime Biologics To Expand Biologics Mfg Capacity with $190-M Funding
Chime Biologics, a Wuhan, China-based CDMO, has secured a total commitment of $190 million in funding from institutional investors to expand its biologics manufacturing capacity.

The company has a modular biomanufacturing facility (GE KuBio) in the Wuhan Bio-Lake Biotech Industry Development Zone of China. Chime Biologics has started the second phase of a facility expansion to increase the total manufacturing capacity to more than 140,000 L within the next five years (as reported on March 26, 2021).

This recent financing round was led by VMS Group and followed by Fidelity International and Panacea Venture. In February 2020, Chime Biologics raised $125 million in funding.

Source: Chime Biologics

Thermo Fisher Launches New System for Biologics Sample Purification
Thermo Fisher Scientific has launched a high-throughput sample purification instrument designed to automate the extraction of DNA, RNA, proteins, and cells from an array of sample types.

The KingFisher Apex enables nucleic acid, protein and cell isolation while allowing users to customize protocols directly from the instrument. It automates preparation of nucleic acids and proteins, can process for 24 to 96 samples in 25 to 65 minutes, and elutes in low volumes (10 µL) for downstream applications.

Source: Thermo Fisher Scientific

Formulation Development/Drug-Product Manufacturing

NextPharma Completes Acquisition of Lonza Sites
NextPharma, a London-headquartered CDMO that specializes in oral and topical finished dosage forms, has completed the acquisitions of two sites from Lonza in Ploermel, France and Edinburgh, UK that specialize in lipid oral dosage forms.

The Ploermel and Edinburgh sites produce liquid-filled hard capsules and softgels (including for high potent and hormonal products.

The acquisition agreement was previously announced in January 2021.

Source: Lonza and NextPharma

Aji Bio-Pharma, AstraZeneca Expand Mfg Pact
Ajinomoto Bio-Pharma Services, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has expanded its manufacturing agreement with AstraZeneca to include drug-product manufacturing.

This agreement expands the scope of Aji Bio-Pharma’s service offerings to AstraZeneca to include aseptic fill–finish services at Ajinomoto Bio-Pharma’s San Diego, California facility in addition to small-molecule manufacturing services from its site in Belgium.

Source: Ajinomoto Bio-Pharma

SK Capital Acquires Catalent’s Blow–Fill–Seal Sterile CDMO Business
SK Capital, a New York-based investment firm, has completed the acquisition of Catalent’s blow–fill–seal (BFS) sterile CDMO business. The business has been renamed Woodstock Sterile Solutions.

Woodstock is a BFS sterile CDMO that operates out of a single site in Woodstock, Illinois and provides services for clinical development and commercial products.

The acquisition agreement was announced in January 2021.

Woodstock has also announced the appointment of Paul Josephs as the company’s CEO effective immediately (as reported on March 31, 2021). He most recently served as Head of Contract Development & Manufacturing and Global Business Development at Mylan (now Viatris). Previously, Mr. Josephs held several leadership roles at DPT Laboratories, a CDMO specializing in semi-solid and liquid dosage forms.

Source: SK Capital

Aenova Expands Sterile Mfg Capacity
Aenova, a Starnberg, Bavaria-based CDMO of sterling manufacturing, has increased ampul capacities at its site in Gronau, Germany.

The new ampoule filling and closing line, the company’s sixth sterile line at the Gronau site, includes a new fully automatic optical control line and a new packaging line to bring sterile production capacity to more than 100 million ampuls and vials annually.

The company also is proceeding with capacity expansions in tablet production at the following sites: Tittmoning, Bavaria, Germany for tablet production; Regensburg, Bavaria, Germany highly potent active ingredients (up to OEB 5); and Latina, Italy for an additional line for aseptic filling. COVID-19 vaccines will be filled at the Latina site.

Source: Aenova

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