Complex Biologics. Clear Momentum.

Talia Biologics is a modern CDMO built for complex biologics, specialty drug product, advanced delivery systems, and nonstandard manufacturing programs that do not fit cleanly into traditional outsourcing categories.

We support biotechnology, biopharma, animal health, diagnostic, rare disease, oncology, and emerging therapeutic companies from early process development through GMP manufacturing, sterile drug product, analytical control, tech transfer, and clinical supply.

Talia was created around a simple idea: biologics development should be scientifically serious, operationally flexible, and commercially realistic at the same time.

Many sponsors do not need the largest CDMO in the world. They need a partner with enough scale to matter, enough technical range to solve unusual problems, and enough attention to move without losing the programme inside a giant system. Talia exists for those sponsors.

We are headquartered across three strategic life science locations: Taipei, Taiwan; Stuttgart, Germany; and Prince Edward Island, Canada.

From Taiwan, we draw on speed, precision manufacturing culture, engineering discipline, supplier responsiveness, and Asia-Pacific biomanufacturing access. From Stuttgart, we draw on German process rigour, quality systems, mechanical engineering excellence, European regulatory seriousness, and the industrial discipline that has shaped some of the world’s most exacting manufacturing sectors.

From Prince Edward Island, we draw on focused North American biomanufacturing strength, applied biotechnology, animal health expertise, fermentation culture, and the practical execution needed to turn complex biology into controlled supply.

Together, these locations give Talia its personality.

Fast, but controlled.
Creative, but documented.
Flexible, but quality-led.
Global, but personal.
Precise, but practical.

Komplexe Biologie braucht klare Prozesse.

讓複雜的生物製程，走向清晰、可靠、可放大的未來。

A CDMO for Biology

The biologics industry has changed.

The classic CDMO model was built around familiar categories: monoclonal antibodies, recombinant proteins, standard microbial expression, standard mammalian expression, standard vials, standard quality packages, standard clinical batches.

Those categories still matter. Talia supports them.

But many of today’s most interesting programmes are not standard.

They may be antibody-drug conjugates, multispecific binders, peptide conjugates, long-acting injectables, radiopharmaceutical precursors, high-concentration subcutaneous biologics, inhaled proteins, nasal biologics, oral delivery platforms, microneedle vaccines, engineered enzymes, VHH-Fc constructs, immunocytokines, fusion proteins, complex recombinant proteins, biosimilars, veterinary biologics, or rare disease products requiring small but highly controlled GMP campaigns.

These programmes are difficult because the molecule, process, route, analytical package, and product format all interact.

A biologic is not only a sequence.
It is not only a cell line.
It is not only a fermentation run.
It is not only a vial.

It is a system.

Expression affects impurity burden. Purification affects yield and aggregation. Formulation affects stability and route. Container closure affects extractables, leachables, particles, adsorption, and dose accuracy. Analytical strategy affects release, comparability, regulatory confidence, and commercial readiness. Tech transfer affects every future batch.

Talia Biologics was built for that full reality.

We do not look at biologics as isolated technical tasks. We look at the complete CMC path: molecule, process, product, analytics, documentation, supply, and risk.

Our Locations

Taipei, Taiwan

Talia’s Taiwan presence is centred in Taipei, with access to the broader Taipei–Hsinchu life science and technology corridor. This gives the company proximity to Taiwan’s advanced manufacturing culture, engineering talent, supplier networks, electronics and instrumentation ecosystem, precision process mindset, and rapidly growing biotechnology sector.

Taiwan is an ideal location for a biologics CDMO built around speed, flexibility, and careful execution. The culture rewards responsiveness, technical problem-solving, dense supplier coordination, and disciplined manufacturing. These qualities matter in biologics, especially for sponsors that need quick feasibility work, practical development feedback, and rapid movement from concept to controlled process.

Our Taiwan operation is designed to support early development, process optimisation, analytical development, formulation screening, microbial and mammalian process work, drug product development, and flexible pilot-scale manufacturing.

It is also the natural home for Talia’s work in emerging biologics, specialty delivery systems, digital manufacturing, data-driven process control, and Asia-Pacific sponsor support.

Stuttgart, Germany

Talia’s European base is in Stuttgart, Germany, one of Europe’s strongest engineering and industrial regions. Stuttgart gives Talia direct access to German manufacturing culture: process discipline, documentation, system thinking, mechanical precision, quality control, and long-term operational planning.

For a CDMO, these values are not abstract. They determine whether a process can be transferred, repeated, validated, inspected, and scaled.

Our Stuttgart operation supports European clients, global regulatory expectations, late-stage process discipline, GMP readiness, quality systems, tech transfer, commercial planning, sterile drug product strategy, and advanced manufacturing partnerships.

Germany gives Talia a quality and engineering backbone. Taiwan gives Talia speed and adaptability. The combination allows us to support sponsors who need both movement and control.

Charlottetown, Prince Edward Island, Canada

Talia’s North American facility is located in Charlottetown, Prince Edward Island, the geographic centre of one of Canada’s most focused bioscience clusters. PEI gives Talia a practical, specialised, and highly collaborative base for biologics development, animal health products, fermentation, natural products, marine bioactives, and applied biotechnology.

Prince Edward Island adds a different kind of strength to Talia’s global model. Taiwan gives us speed and technical responsiveness. Stuttgart gives us engineering discipline and European quality structure. Charlottetown gives us focused North American execution: close collaboration, flexible development capacity, bioprocessing experience, and a regional life science culture built around moving specialised products from early promise toward controlled manufacturing.

PEI is especially well suited for programmes that need serious development support without being absorbed into an oversized CDMO system. Its bioscience ecosystem is strong in human health, animal health, diagnostics, natural product chemistry, fermentation, and bio-based manufacturing. These strengths make the location a natural fit for complex biologics, veterinary biologics, recombinant proteins, enzymes, microbial processes, bioactives, specialty formulations, and practical GMP manufacturing pathways.

Our Prince Edward Island operation is designed to support North American clients with process development, analytical support, pilot manufacturing, formulation screening, microbial and mammalian process work, animal health biologics, specialty drug product strategy, and scalable supply planning.

It is also a natural home for Talia’s work in nonstandard biologics: products that require careful development, clear analytics, flexible batch strategy, and practical manufacturing discipline rather than a generic platform approach.

Charlottetown gives Talia a grounded North American manufacturing presence. It strengthens our ability to support sponsors that need flexibility, technical clarity, and development work close to the realities of clinical supply, veterinary use, bioactive production, and commercial readiness.

Taipei moves quickly.
Stuttgart structures deeply.
Charlottetown builds practically.

Together, these three locations give Talia a balanced global footprint across Asia-Pacific, Europe, and North America.

What We Manufacture

Talia Biologics supports a broad range of biologic and biologic-adjacent modalities, including:

• Monoclonal antibodies
• Bispecific and multispecific antibodies
• Antibody fragments
• VHH, VHH-Fc, Fab, and scFv constructs
• Fc-fusion proteins
• Recombinant proteins
• Enzymes
• Cytokines and immune proteins
• Fusion proteins and receptor traps
• Immunocytokines
• Biosimilars
• Peptides and peptide conjugates
• Antibody-drug conjugates
• Bioconjugates
• Targeted protein therapeutics
• Veterinary biologics
• Diagnostic proteins and reagents
• High-concentration biologics
• Long-acting injectable biologics
• Specialty sterile biologic drug products
• Emerging biologics that require custom development paths

We are especially focused on programmes where ordinary CDMO categories are not enough.

If a sponsor has a standard recombinant protein, we can support it. If the sponsor has an unstable fusion protein, a high-viscosity subcutaneous biologic, a conjugated peptide, a multispecific binder, a veterinary sterile injectable, a rare disease biologic, or a drug product route that creates manufacturing risk, Talia is designed to engage early and help define the path.

Capabilities and Scale

Talia is built as a focused mid-scale biologics CDMO: large enough for serious development and GMP manufacturing, but flexible enough for emerging and nonstandard programmes.

Our platform is designed around modular scale, route-specific drug product strategy, and integrated analytical control.

Upstream and Fermentation Scale

Talia’s development and manufacturing network is designed to support both microbial and mammalian systems, with capacity ranging from bench development to significant clinical and commercial scale.

Representative scale includes:

• 2 L to 10 L bench-scale process development
• 20 L to 50 L development bioreactors
• 100 L to 250 L pilot-scale systems
• 500 L intermediate development and engineering runs
• 1,000 L to 2,000 L clinical manufacturing scale
• 5,000 L microbial and biologics production scale
• 10,000 L to 20,000 L large-scale fermentation capacity
• Up to 40,000 L commercial-scale microbial fermentation capability through integrated manufacturing infrastructure

This gives Talia the ability to support early development, process optimisation, pilot material, toxicology supply, GMP clinical manufacturing, process characterisation, and larger-scale supply planning.

For microbial programmes, we support E. coli, yeast, and other microbial expression platforms where appropriate. For mammalian programmes, we support CHO, HEK293, and related biologics expression workflows through development, scale-up, purification, and GMP manufacturing strategies.

Downstream Processing

Downstream processing is where many biologics programmes succeed or fail. Expression alone is not enough. A process must remove impurities, protect product quality, maintain yield, preserve biological activity, and create a material that can be formulated, filled, tested, and released.

Talia supports downstream dev and manufacturing activities including:

• Clarification
• Depth filtration
• Centrifugation strategy
• Ultrafiltration and diafiltration
• Chromatography process development
• Affinity purification
• Ion exchange chromatography
• Hydrophobic interaction chromatography
• Size exclusion polishing
• Viral clearance strategy
• Endotoxin reduction
• Host-cell protein reduction
• Residual DNA control
• Aggregation control
• Buffer exchange
• Concentration
• Process scale-up
• Process robustness evaluation

For complex biologics, downstream processing cannot be treated as a generic template.

A VHH-Fc construct, bispecific antibody, enzyme, fusion protein, ADC intermediate, high-concentration biologic, and veterinary injectable may each require a different purification and analytical strategy.

Talia develops downstream workflows around the molecule, not around a fixed platform that may or may not fit.

Drug Product and Fill-Finish

Talia gives special attention to drug product because this is where many biologics programmes encounter late risk.

A molecule may express well and purify cleanly, but still fail as a product because the formulation is unstable, the concentration is too high, the route is difficult, the container closure is incompatible, the product aggregates, the lyophilisation cycle is weak, the fill volume is too small, or the final presentation does not match clinical and commercial use.

Talia supports drug product development for:

• Sterile liquid biologics
• Lyophilised biologics
• High-concentration subcutaneous products
• Vial presentations
• Prefilled syringes
• Cartridges
• Autoinjector-ready formats
• Ophthalmic sterile biologics
• Nasal biologics
• Inhaled biologics
• Long-acting injectables
• Peptide and peptide-conjugate injectables
• Veterinary sterile products
• Rare disease and orphan drug products
• Small-batch clinical supply

Our fill-finish and drug product capabilities are designed for sponsors that need flexible sterile supply without being forced into an oversized commercial system too early.

Talia supports small-batch clinical fill, pilot fill, formulation screening, container closure evaluation, lyophilisation cycle development, visual inspection strategy, release testing alignment, and packaging readiness.

Advanced Services

Talia is not only a process development and GMP manufacturing partner. The brand is also built around advanced service categories that are increasingly important to modern biologics.

ADC and Bioconjugation Support

Talia supports antibody-drug conjugate and broader bioconjugation programmes through conjugation strategy, linker-payload coordination, purification, analytical development, DAR control, impurity assessment, stability strategy, and sterile drug product planning.

We view conjugation as a platform, not only as an ADC category. Bioconjugation can include antibody-drug conjugates, peptide-drug conjugates, radioconjugates, diagnostic conjugates, fluorescent conjugates, polymer conjugates, antibody-enzyme conjugates, and albumin-binding formats.

Peptides and Peptide Conjugates

Peptide therapeutics are expanding rapidly across metabolic disease, oncology, rare disease, immunology, and long-acting delivery. Talia supports peptide and peptide-conjugate programmes through development planning, analytical strategy, formulation, sterile drug product, long-acting delivery, and GMP manufacturing coordination.

We are especially interested in peptide products that require more than sequence synthesis: conjugation, depot delivery, high-purity analytics, sterile fill, lyophilisation, device compatibility, or controlled-release formulation.

Radiopharmaceutical and Theranostic Support

Radiopharmaceuticals operate on a different clock. They require disciplined coordination, short half-life logistics, precise chelation chemistry, sterility, fast release, and specialised quality controls.

Talia supports radiopharmaceutical and theranostic programmes through development planning, chelation and radiolabeling strategy, conjugate characterisation, sterile manufacturing coordination, release testing alignment, and time-critical supply chain design.

Oral, Nasal, Inhaled, and Transdermal Biologics

The future of biologics will not be limited to intravenous infusion and standard subcutaneous injection.

Talia supports alternative biologic delivery strategies including:

• Oral biologics
• Enteric protection
• Permeability enhancement
• Microencapsulation
• Nasal biologics
• Mucosal delivery
• Inhaled proteins and peptides
• Dry powder biologics
• Nebulised biologics
• Transdermal systems
• Microneedle biologic delivery

These routes create formulation, stability, device, analytical, and manufacturing challenges. Talia helps sponsors evaluate those challenges early instead of discovering them after the programme has already committed to the wrong development path.

Long-Acting Injectables and Depot Systems

Long-acting delivery can transform a product’s clinical and commercial value. It can also make development significantly more difficult.

Talia supports long-acting injectable development, including depot systems, PLGA microspheres, injectable suspensions, implants, and controlled-release biologic and peptide formulations.

Our approach connects formulation science, release kinetics, process reproducibility, sterility, particle control, syringeability, stability, and manufacturing scale.

Analytical Development and Quality Control

Analytics are not an accessory to biologics manufacturing. They are the foundation of control.

Talia supports analytical dev & quality control for complex biologics, including:

• Method development
• Method qualification
• Release testing strategy
• Potency assay development
• Cell-based assays
• Binding assays
• Purity and impurity analysis
• HCP analytics
• Residual DNA testing
• Endotoxin and pyrogen control
• Aggregation analysis
• Charge variant analysis
• Glycosylation analysis
• Peptide mapping
• Mass spectrometry strategy
• Stability-indicating methods
• Forced degradation
• Comparability studies
• Extractables and leachables support
• Container closure integrity
• Viral safety and clearance strategy

For many programmes, the analytical package is the real development bottleneck. A process cannot scale if the product cannot be measured. A formulation cannot be defended if stability is unclear. A tech transfer cannot succeed if comparability is weak. A biosimilar cannot advance if analytical similarity is not disciplined.

Talia builds analytics into the programme early so sponsors can make decisions with evidence rather than hope.

CMC Rescue and Tech Transfer

Many of the most valuable CDMO projects begin when things have already gone wrong: processes fail to scale, yields collapse, products aggregate, formulations become unstable, timelines break, or documentation falters—leaving programs technically alive but operationally stuck.

Talia Biologics delivers CMC rescue and tech transfer for biologics programs under pressure. Our team quickly assesses what’s known, what’s missing, what can be recovered, and what must be rebuilt by reviewing process history, analytical methods, batch records, deviations, impurities, scale-up assumptions, and regulatory risks.

We then build a clear path forward—through process redevelopment, analytical rescue, formulation redesign, comparability planning, new CDMO transfers, GMP readiness, or clinical supply recovery.

When the path breaks, Talia rebuilds it.

This is a defining strength of the company. Promising biologics rarely fail because the biology is wrong—they fail when the CMC path becomes disorganized. Talia exists to restore structure.

Biosimilars and Commercial Readiness

Biosimilars require a different kind of discipline. They are not simply “generic biologics.” They require deep analytical similarity, process control, comparability, regulatory strategy, cost discipline, and scalable manufacturing.

Talia supports biosimilar and biobetter development through:

• Reference product analysis
• Cell line and expression strategy
• Process development
• Analytical similarity
• Comparability studies
• Glycosylation evaluation
• Potency assay strategy
• Scale-up
• Formulation
• Device and presentation planning
• GMP manufacturing coordination
• Regulatory documentation support

For biosimilar sponsors, the work is not only to make the molecule. The work is to prove, repeatedly and defensibly, that the product belongs in the same therapeutic conversation as the reference product.

Talia helps build that evidence.

Packaging, Labeling, Serialization, and Cold Chain

A biologics programme does not end at manufacturing. It must be packaged, labelled, stored, shipped, tracked, and delivered under controlled conditions.

Talia supports clinical and commercial supply preparation, including:

• Clinical packaging
• Labeling
• Serialization strategy
• Aggregation planning
• Kit assembly
• Temperature-controlled packaging
• Cold chain logistics
• Ultra-cold storage planning
• Cryogenic supply support
• Stability-aligned shipping
• Chain-of-custody planning
• Chain-of-identity planning for applicable products
• Import/export coordination support
• Depot and distribution partner coordination

For complex biologics, supply chain is part of product quality. Temperature excursions, labeling errors, packaging incompatibility, and distribution delays can damage a programme as severely as upstream or downstream failure.

Talia treats packaging and supply as part of the CMC system.

Industries We Serve

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Talia works with sponsors across several life science sectors.

Biotech and Emerging Biopharma

We support venture-backed, founder-led, university spinout, and emerging biopharma companies that need practical CDMO support before they have large internal CMC teams.

Established Biopharma

For larger companies, Talia supports specialty projects, overflow work, tech transfer, analytical development, nonstandard formats, drug product strategy, and programmes that require flexible attention.

Oncology

Talia supports oncology programmes including ADCs, radiopharmaceuticals, bispecifics, immunocytokines, targeted protein therapeutics, antibody fragments, and specialty injectables.

Rare Disease

Rare disease programmes often need small-batch, high-touch, flexible manufacturing models. Talia supports orphan biologics where scale may be limited but quality requirements remain serious.

Animal Health

Veterinary biologics require practical development strategies matched to species, route, economics, dose, stability, and real-world use. Talia supports sterile injectables, oral biologics, topical biologics, animal vaccines, recombinant proteins, and specialty animal health products.

Diagnostics and Research Tools

Diagnostic proteins, antibody fragments, enzymes, conjugates, and reagent-grade biologics require manufacturing discipline even when they are not therapeutic products.

Talia supports development and production strategies for these markets.

How We Work

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Talia’s working style is direct.

We begin by understanding the programme: molecule, modality, expression system, stage, indication, route, current data, process history, quality expectations, target batch size, regulatory path, and timeline.

Then we identify the central risk.

For some programmes, the risk is expression. For others, it is purification. For others, it is potency. For others, it is formulation. For others, it is sterile filling. For others, it is the fact that no one has yet defined what the product actually needs to become.

We do not assume the answer before understanding the system.

Our teams build development plans that are technically grounded and commercially aware. We know sponsors must make decisions under budget pressure, investor timelines, clinical deadlines, and regulatory uncertainty. A good CDMO does not ignore those pressures. A good CDMO helps organise them.

Talia is designed to be transparent, responsive, and serious. We do not hide behind vague platform language. We help sponsors understand what is possible, what is risky, what should be done first, what can wait, and where the programme needs stronger evidence.

The Talia Difference

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Talia Biologics is built around five operating principles.

1. Complex Biology Needs Custom Thinking

Not every biologic belongs on a standard platform. We adapt the process to the product.

2. Drug Product Matters Early

Route, formulation, container closure, fill-finish, and stability should influence development decisions before it is too late.

3. Analytics Create Confidence

A programme cannot move confidently if the product cannot be measured clearly.

4. Scale Must Be Designed, Not Assumed

A 2 L result does not automatically become a 2,000 L process. Scale-up requires engineering, controls, and comparability.

5. Speed Without Quality Is Not Progress

Fast work only matters if it creates usable, defensible, transferable data.

These principles shape how we work with every sponsor.

Built for the Next Generation of CDMO Clients

The next generation of biologics companies will not all look the same. Some will be virtual. Some will be AI-native. Some will be platform companies. Some will be rare disease companies with one asset. Some will be animal health innovators. Some will be diagnostic companies moving into therapeutic manufacturing. Some will be oncology companies with conjugates, radioligands, and multispecifics. Some will be developing delivery technology as much as therapeutic biology.

Talia is built for these companies.

We support sponsors that need a CDMO partner capable of thinking across modality, route, analytics, quality, supply, and future scale.

Our role is to help turn difficult biology into a controlled development path.

From Taipei to Stuttgart to Charlottetown, from early process to GMP manufacturing, from molecule to drug product, from stalled programme to renewed momentum, Talia Biologics exists to help clients advance complex biologics with precision, flexibility, and confidence.

Taipei gives Talia speed and technical responsiveness. Stuttgart gives Talia engineering discipline and quality structure. Charlottetown gives Talia a focused North American base for practical biomanufacturing, animal health, fermentation, specialty biologics, and scalable supply planning.

Together, these locations form a CDMO model built for the next generation of complex biology.

讓複雜的生物製程，走向清晰、可靠、可放大的未來。